Job Search

Considering local San Francisco Bay Area candidates only.

The Senior Administrative Associate supports the assigned manager and team with a variety of departmental administration and operational activities:

• Act as the departmental "go-to-person" for general operational, administrative questions or other inquiries
• Assist the assigned team in various administrative or operational activities such as coordinating, scheduling and preparing for meetings or presentations, gathering information and/or conducting analyses needed for the department's work, formatting or editing departmental materials, presentation or other documentation, channeling communication between the department and other GNE groups, planning, coordinating and managing various meetings and events, payment and expense report processing, etc.
• Ensure all assigned work is completed on-time and without compromise to quality; fully meeting or exceeding expectations, goals and targets
• Improve work unit efficiency by streamlining and reducing administrative or operational burdens from manager and other team members
• Work collaboratively, effectively and efficiently with all internal/external partners & stakeholders
• Participate, as and when needed/appropriate, in cross-functional or other project teams; helping the overall business of Genentech to continuously evolve, improve & excel
• Follows all laws, regulations and policies that govern the conduct of all activities. Is accountable for being fully knowledgeable of all relevant policies and for abiding by these
• Does not compromise ethics or integrity, or undertake legal risks while pursuing business goals
• Demonstrates leadership among peers by consistent application and modeling of the appropriate compliance, behavior and conduct

Who You Are

• High school diploma, Bachelor's degree a plus
• Minimum 7 years of related experience supporting management (experience gained in the pharmaceutical/biotech industry is a plus)
• Experience working globally, including knowledge of setting up video conferences globally
• Knowledge of Roche systems such as PlanSource, PharmaRes.
• Ability to work starting at 7:30am PST in South San Francisco.
• Must demonstrate outstanding computer skills and specific proficiencies with Microsoft Word, Excel, PowerPoint, and Google Calendar
• Previous experience must include responsibilities for managing confidential information
• Previous experience for training other staff in company or departmental systems, processes, and other general or administrative tools is strongly preferred
• Must demonstrate aptitude to learn GNE - specific calendar and other operational systems
• Proven track record of meeting or exceeding objectives & goals
• Impeccable ethics and integrity
• Strong time management, organization, & prioritization skills with proven abilities to work independently
• Strong project management skills: proven abilities to effectively and efficiently manage multiple, often competing, priorities through to successful conclusion
• Strong attention-to-detail
• Strong communication skills, both written & verbal
• Financial acumen capable of effective & efficient tracking, analysis and reporting on departmental budgets

POSITION SUMMARY
The convergence of scientific knowledge and advanced technology has created an unprecedented opportunity for the biotechnology industry to improve outcomes for patients today and in the future. The Personalized Healthcare (PHC) function aims to transform drug development and enable patient access and patient care by leveraging meaningful data at scale – high-dimensionality datasets with longitudinal clinical trial and real-world data from large cohorts of patients, with deep characterization of individuals using techniques such as whole genome sequencing, transcriptomics, immune system profiling, anatomic and pathology imaging, and digital approaches to continuous monitoring. The PDP function builds capabilities for data and insight sharing; applies advanced analytics to identify novel targets and biomarkers to increase development productivity and new methods for characterizing disease states and quantifying disease activity; generates insights to fundamentally change the drug development paradigm; and shapes the internal and external environment to enable value recognition from these insights.

The Digital Health Platforms department within PDP is chiefly responsible for late-stage development of digital tools, including devices and mobile medical applications, which enable patient data collection, monitoring, and optimized care of patients across a range of therapeutic areas. This newly created role, Senior/Principal Scientist, Digital Health Platforms, reporting to the Global Head Digital Health Platforms will collaborate closely with the I2O function, other digital health groups across Roche, as well as internal partners within PDP, Product Development, the Research and Early Development (gRED, pRED) organizations, Roche Diagnostics, Pharma Partnering and Information Technology to set and implement the strategy and direction for digital health to transform drug development in specific areas of respiratory disease.

RESPONSIBILITIES

• DEVELOP & DRIVE DIGITAL HEALTH STRATEGIES: In collaboration with clinical development programs and other digital health groups within Roche, develop and drive overarching digital health strategies to support research and development of our molecules and enable personalized patient care and access. Lead/participate in investigator meetings, advisory committee meetings.
• DELIVER PORTFOLIO AND BUSINESS: Resource molecule and disease area teams and initiatives effectively with internal and outsourced capabilities to deliver high quality, rigorous and fit-for-purpose digital health solutions according to company priorities and opportunities to impact business. Provide expert advice to the Program team for the clinical development of digital platforms and therapeutics. Originate, review and provide valuable input into clinical documentation to support clinical development and regulatory filings.
• SHAPE INTERNAL & EXTERNAL ENVIRONMENT: Lead or contribute significantly to functional, cross functional, enterprise-wide or external digital health communities, networks, collaborations, initiatives or goals on knowledge-sharing, methodologies, innovations, technology, IT infrastructure, policy-shaping, etc. to enable broader and more effective use of digital health platforms to support business.
• ACQUIRE EXTERNAL CAPABILITIES: Collaborate with internal partners in due-diligence to assess and acquire/ collaborate with external capabilities in digital health, etc. of strategic business fit to the business.
• INNOVATE OUR FUNCTION: Define functional objectives and strategy, identify opportunities, gaps and priorities, and contribute to best practice standards. Stay abreast of emergent applications, methodologies, technologies, and external guidelines, and implement change to positively evolve the function’s capabilities and impacts.
• FOSTER OUR CULTURE: Develop strong internal partnerships to promote effective collaborations. Lead by example in promoting a collaborative and entrepreneurial culture and a global mindset. Be an agent for change and engage support for innovative ideas and solution.

MINIMUM QUALIFICATIONS

• MD, PhD or equivalent, with significant experience in drug development.
• Subject matter expertise and clinical experience in respiratory medicine preferable in asthma.
• Track record of success in developing digital health platforms, including validation, evidence development for clinical utility, and regulatory clearance/approval.
• Experience with digital application, concepts, tools, language.
• Track record of effectively building, leading and managing in a matrix environment with global, international team with members coming from scientific, business and operational backgrounds, using influence without authority.
• Proven ability to identify and implement innovative ideas.
• Excellent communication skills. Proven ability to translate and communicate complex ideas, concepts, and data science solutions to diverse audiences.
• Excellent collaboration and leadership skills. Ability to motivate and inspire teams and manage change
• Proficiency in English, both written and verbal.

• PREFERRED QUALIFICATIONS

  Licensed and Board-Certified in Pulmonary Medicine.

  *LI-PD-HB 

• Technical leadership and/or support of GMP processes, process analysis and process equipment:
  • Having a customer service mindset to provide technical leadership supporting manufacturing operations through process monitoring, trouble shooting of processes to ensure the health of the process and equipment.  Have the ability to identify issues, analyze the potential risk, formulate and implement corrective actions.
  • Uphold quality standards by ensuring compliance with Pharmaceutical Quality Systems and with Global Standards and Process; providing technical leadership to ensure the efficacy of risk assessments, providing technical support for complex investigations, CAPAs and quality discrepancy while driving closure to timelines.
  • Provide technical leadership for the tech transfer of new and commercialized products by leading facility fit, process capability and process gap analysis.  Leading cross-functional teams to execute process characterization and support regulatory filings.   
  • Have the ability to author and/ or provide guidance for the authoring of controlled documents to support process validation, equipment commissioning, and qualification of equipment and complex systems.
  • Participate in cross function teams to support expense/capital projects through design, construction, implementation, commissioning and qualification activities; with the ability to provide guidance and oversight of contract staff.  Participate in system and equipment design, utilizing engineering documentation such as PFDs, P&IDs, URSs, Design Specifications, data sheets, piping isometrics, Installation/ Operation Qualification, Process Qualification and Process Validation.
  • Ensures the integration of environmental health, safety, and security into the business processes, systems, and programs while reporting safety and environmental incidents including injuries, illnesses, and safety suggestions within one’s functional area.  Fosters a positive safety culture in which no one gets hurt.
  • Interact with vendors to assist in projects, trouble shooting and investigations.  Review vendor information packages, including drawings and specifications. 

• Supplementary Responsibilities:
  • Have the ability to participate in cross functional teams to coordinate activities and provide engineering leadership.
  • Participate in cross functional teams representing Process Engineering as the technical steward of the process and process equipment.
  • Participate on global teams to implement network initiatives at the local level.
  • Have the ability to support senior staff to drive outstanding items to closure without compromising quality.
  • Have the understanding of automated processes, instrumentation and control systems.
  • Present data and concepts at department, project team and other meetings within company and at outside conferences.
  • May provide direction to sub-contracting groups in the design and installation of process and clean utility systems.  Participate in the design specification testing and execute field studies.

Job Requirements

Education and Experience

• Bachelor’s or Master’s degree in Engineering (Chemical or Electrical preferred) and 5 years of experience, or Master’s degree in Engineering (Chemical or Electrical preferred) and 4 years of experience.
• Minimum of 5 years applicable instrument and control system experience.
• Minimum of 3 years in the pharmaceutical/biotech industry/GMP experience.

Knowledge, Skills and Abilities

• Knowledge of cGMP guidelines and familiarity in working with controlled documents.
• Ability to comply with cGMP requirements to work in clean manufacturing spaces, i.e., gowning protocols, documentation and procedures.
• Experience in process monitoring and process capability.
• Ability to review process data, analyze trends and make process recommendations.
• Ability to assess impact of changes on the process and equipment.
• Experience in the design, installation and operations of GMP process equipments.
• Validation/Commissioning experience of large scale process equipment and systems.
• Ability to generate engineering design drawings and specifications.
• Ability to perform validation and/or engineering studies and analyze the results to write formal reports.
• Understanding of clean/aseptic manufacturing process and equipment.
• Demonstrate good organizational and time-management skills.
• Demonstrate strong interpersonal skills including the ability to interact with individuals of various backgrounds and levels of technical expertise.
• Demonstrate strong written and verbal communication skills.
• Ability to work in a fast-paced environment including the ability to adapt to changing priorities as necessary to achieve department and corporate goals within established timelines.
• Ability to communicate technical issues to a diverse group, ranging from process scientists to field technicians.
• Demonstrate the ability to make decisions using excellent business and technical judgment.
• Ability to comply with cGMP requirements to work in clean manufacturing spaces, i.e., gowning protocols, documentation and procedures.
• Demonstrate proficiency in word processing, spreadsheet, database, project management and presentation software applications.
• Demonstrate a high-degree of analytical and problem-solving skills, with emphasis on very technical issues relating to process controls, automation systems, and general control theory.

Work Environment/Physical Demands/Safety Considerations

• Work in standard office environment.
• May work in the clean room environment that requires gowning in the form of hospital scrubs, bunny suits, gloves and steel toe boots be worn.  Also, no make up or jewelry can be worn when working in the clean room environment.
• May work with hazardous materials and chemicals.

* This is for temporary employment for a duration of 12 months *

Responsible for producing innovative biotherapeutic medicine by interfacing with highly automated production systems and controls in cGMP manufacturing environment, and maintain areas in high state of inspection preparedness.  Operates production equipment for cell culture or purification that may include culture growth, process monitoring, sampling, harvesting, purification, formulation, freeze thaw and transfer.  Performs media/buffer solution preparation operations.  Maintains records and clean room environment to comply with regulatory requirements utilizing current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP).  Responsible for being proficient in one functional area.  Understands and applies biological, chemical and mechanical principles and techniques.

Job Responsibilities

• Operate systems that clean and sterilize tanks and filtration systems. 
• Prepare solutions for the production process.
• Review documentation and check all calculations (e.g. tickets, labels, equipment reading).
• Trouble shoot equipment and process problems.
• Comply with safety requirements, cGMP, SOP and manufacturing documentation.
• Use of automation to perform production operations.
• Provide support to Manufacturing to meet production demands.
• Operate automated systems for equipment operation.
• Assemble and prepare equipment for production.
• Exhibit detail oriented documentation skills.
• Communicate effectively and ability to work in a team environment.
• Exhibit professional interpersonal skills.
• Work with coworkers and supervisor to effectively troubleshoot minor equipment and process issues.
• A good working knowledge of biopharm technology and processes. 
• Trained and skilled in all operational procedures of at least one manufacturing department.
• Demonstrated ability to independently document and record information related to the process.
• Occasionally makes routine decisions based on experience.  Identifies and suggests solutions to common basic problems.
• Recognizes non-routine problems, investigates and suggests potential solutions.
• Judgment is required in resolving problems and making routine recommendations. 
• Ability to recognize deviation from accepted practices is required.
• All employees with jobs that require access to the Warehouse must be able to pass the Transportation Security Administration (TSA) Security Threat Assessment (STA).
• Follows established safety and environmental guidelines and procedures for all work performed.  Immediately reports safety and environmental incidents including injuries, illnesses, near misses, and safety suggestions.  Fosters a positive safety culture in which no one gets hurt.

Supplementary Responsibilities

• Operate fermenters, centrifuges, other harvest systems and protein purifications units.
• Operate and clean fixed tank and filtration systems.
• Operate large scale column chromatography systems.
• Operate small-scale cell culture areas and systems by operating cleaning, set up, and maintaining 20L batch feed fermenters; inoculating and maintaining spinner seed cultures using aseptic techniques, maintaining cell banks; and performing general seed lab operations.
• Perform Solution Preparation activities (media and buffer make-up).
• Clean, assemble, and sterilize equipment using glass washers and autoclaves.
• Perform automated CIP and SIP of fixed equipment.

Job Requirements

Education and Experience

• Degree in Life Sciences or Engineering and 1 year related experience, or Associate degree and 3 years experience, or High school and 5 years experience.
• Biotech certificate from approved program.

Knowledge, Skills and Abilities

• Strong oral and written communication skills.
• Familiarity of computer-based systems.
• Background in fermentation.
• Ability to receive, interpret and provide basic information and materials involved with the day to day activities of performing the job.
• Schedule could include a non-rotating 12 hour shift, one weekend day, evening or night hours, or full off-shift hours.

We are seeking a Scientific Manager in the Department of Molecular Biology to develop and oversee a newly founded Cell Engineering Lab. She/he is expected to manage a broadly-functional team that will facilitate the design, execution, and validation of cell line engineering projects initiated by researchers across Genentech -- with the ultimate goal of generating more effective in vitro/ex vivo disease models and contexts for functional genomic screening. In addition to developing and optimizing methods for immortalized cell, primary cell, and organoid growth or manipulation, the Cell Engineering Lab will work closely with Genentech’s world-class cell line validation team (https://www.nature.com/articles/nature14397) to establish a centralized resource of modified cell lines. The candidate is expected to work creatively and independently within an extremely dynamic, collaborative research environment.

A highly-motivated candidate with a PhD in Genetics, Molecular Biology, Biochemistry, Cancer Biology, or a related discipline. Qualified individuals will have direct managerial experience and a skill set demonstrating successful application of molecular genetics/genome engineering either in cell-based systems or model organisms. Furthermore, candidates should have substantial, documented experience with some or all of the following: DNA nucleases, 2D and 3D cell culture, RNA interference, reporter gene assays, primary and/or stem cell models, molecular cloning, RNA/DNA/protein quantification, epigenetics, and viral vector development/use. Working knowledge of Next-Gen Sequencing (NGS), biostatistics, and/or basic bioinformatics is desirable. The successful candidate will be organized, a pro-active collaborator, and have excellent communication skills, both written and verbal.

The Senior/Clinical Project Manager leads medical writing and editing projects primarily for Early Stage Clinical Development but also the Late Stage Clinical Development organization, partnering closely with key stakeholders: Clinical Science Leaders (CSLs), Medical Directors, Clinical Scientists, and protocol authoring teams. This position resides within the Product Development Clinical Science (PDC) organization.

Functions/Responsibilities:

· Oversees the development of protocols, including timeline development, protocol drafting, coordination of  reviews, incorporation of team review comments, publishing, and signoff.

· Acts as a key strategic thinking partner for the Development Subteam Leader (DSTL) and other gRED Early Clinical Development (ECD) team members on protocol development and the above deliverables.

· Is a key strategic participant in project teams and committees.

· Acquires and demonstrates a deep understanding of needs for the gRED ECD organization.

· Is a key member of the PDC Business Operations Group, keeping team members apprised of projects and timelines.

Who you are

· Bachelor’s degree with a minimum of 8 years of medical writing and clinical project management experience, preferably in the Biotech/Pharmaceutical industry

· Masters or PhD degree in the biological sciences or liberal arts preferred

· Superb written and oral communication skills, with a proven ability to communicate effectively with all levels in the organization.

· Demonstrated experience in clinical and nonclinical document preparation and finalization.

· Strong project management and team facilitation skills.

· Demonstrated ability to collaborate and negotiate business solutions in a complex and fast paced matrix environment.

· Team player with demonstrated strong interpersonal skills and ability to build effective working relationships throughout all levels of the organization.

· Strong analytical and problem solving skills, paired with strong partnering and performance consulting skills.

· Ability to work independently and as part of a team.

· Strong planning and organizational skills, including ability to prioritize and organize high volume workflow and follow a project through to completion, ensuring attention to detail, and highest level of accuracy within required timeframe.

· High degree of customer focused sensitivity towards both internal and external customers and business partners.

This job may require approximately 5% international travel.

Main Accountabilities and Responsibilities:
• Accountable for local oversight of the Roche-QuintileslMS FSP model -- and other CROs where applicable, which perform
activities under Roche sponsorship -- to the quality, standards and competency level required.
• Ensures optimal performance and drives best practices, high performance and delivery; also provides proactive issue
management and resolution through collaboration and effective partnership.
• Provides guidance to local study teams on ensuring QuintileslMS (and other CROs as required) are provided with relevant
portfolio/study information and related projected country requirements to ensure study requirements are met effectively
in terms of resources, competency, skills and experience.
• Leads all local partnership meetings with all vendors, to align and oversee goals, training and implementation of
continuous improvement.
• In accordance with all applicable local employment laws, ensures there is effective two-way communication/feedback
with vendors to support performance management discussions by responsible line managers.
• Seeks and measures internal and external stakeholder/customer satisfaction with local CR0 service levels and implements
appropriate escalation and resolution as needed.
• Identifies areas for continuous improvement within scope of vendor management and is responsible for rolling out
related change management initiatives.
• Reviews, analyzes and reports Key Performance Indicators (KPIs) and performance metrics against benchmarks for local
vendors and their staff, ensuring proactive problem solving and continuous improvement.
• Creates and maintains effective communication plans between Roche and local vendors at the local level. If working in a
regional/subregional setting, is responsible for following the regional/subregional communication plan. Ensures
information flows to/from internal stakeholders and appropriate vendors.
• Responsible for cascading and distributing information to internal Roche stakeholders and to appropriate vendors.
• Ensures effective resource management with the CR0 counterpart, liaising with other CCO staff (Therapeutic Area
Leaders, Resource Manager) as required.
• Implements and maintains accurate service agreements/contracts and budget information as it relates to local vendor
management in collaboration with Procurement, Finance and other Roche stakeholders. Ensures local delivery is aligned
with the global Master Service Agreements (where in place).
• Develops tools, processes and instructions to continuously improve vendor management locally.
• Trains local Roche staff on the principles and procedures governing collaboration with vendors.
• Ensures vendor oversight and performance in compliance with regulatory requirements and represents Roche in audit
and inspection activities related to vendor management.
• Accountable for risk management, locally, of all vendors and vendor activities by close oversight and collaboration with
internal and external stakeholders.
Qualifications:
University Degree or equivalent preferably in a medical/science-related field. Recommended senior experience in Clinical
Research/Development or related industry. Experience working with procurement and/or collaborating with/managing
vendors. Previous line management experience/supervision of staff (if applicable).
Competencies:
• Communication — conveys information and ideas clearly and concisely to individuals or groups in an engaging manner
that helps them understand and retain the message; listens actively to others.
• Building Partnerships — develops and leverages relationships within and across work groups to achieve results.

• Decision Making — identifies and understands problems and opportunities by gathering, analyzing and interpreting
quantitative and qualitative information; choosing the best course of action by establishing clear decision criteria,
generating and evaluating alternatives, and making timely decisions; taking action that is consistent with available facts
and constraints, and optimizes probable consequences.
• Planning and Organizing Work — establishes an action plan for self and others to complete work efficiently and on time
by setting priorities, establishing timelines, and leveraging resources.
• Resolving conflict — Helps others deal effectively with an antagonistic situation to minimize damage to the relationship
and promotes shared goals; uses appropriate methods to reduce tension or conflict between two or more people and
facilitate agreement.
• Influencing — uses effective involvement and persuasion strategies to gain acceptance of ideas and commitment to actions
that support specific work outcomes.
• Building Customer Relationships — ensures that the customer’s internal or external needs are met; builds productive
relationships with high-priority customers; takes accountability for customer satisfaction and loyalty; uses appropriate
interpersonal techniques to prevent and resolve escalated customer complaints and regain customer confidence.
• Creating Culture of Trust — fosters a work environment that encourages people to act with integrity and treat each other
and their ideas with respect; creates and protects a high-trust environment by setting an example, advocating for others in
the face of challenges, removing barriers to trust, and rewarding others for demonstrating behaviors that cultivate trust.
• Technical Knowledge/Skills — Has achieved a satisfactory level of technical, functional, and/or professional skill or
knowledge in position-related areas; keeps up with current developments and trends in areas of expertise; leverages
expert knowledge to accomplish results.
• Adaptability — maintains effectiveness when experiencing major changes in work responsibilities or environment (e.g.,
people, processes, structure, or culture); adjusts effectively to change by exploring the benefits, trying new approaches,
and collaborating with others to make the change successful.
• Facilitating Change — encourages others to implement better approaches to address problems and opportunities; leads
the implementation and acceptance of change within the workplace
• Innovation — creates novel solutions with measurable value for existing and potential customers (internal or external);
experiments with new ways to solve work problems and seizes opportunities that result in unique and differentiated solutions.
Other:
• Availability to travel domestically and internationally if required.

Join a Biotechnology Leader

For more than 30 years, Genentech has been at the forefront of the biotechnology industry, using human genetic

information to develop novel medicines for serious and life-threatening diseases. Today, Genentech is among the

world’s leading biotech companies, with multiple therapies on the market for cancer and other serious medical

conditions.

Our founders believed that hiring talented, enthusiastic people would make Genentech a success. Today, we still believe

our employees are our most important asset. For this reason, we aim to provide employees with a stimulating and

collaborative environment where they can make important contributions to medicine and thrive as professionals.

Commercial Rotation Program Overview

The Commercial Rotation Development Program

The Commercial Rotation Development Program provides the opportunity for high potential future leaders to gain

exposure to functions that are critical to the Commercial Organization. This is accomplished over an approximate

two-year period through a mix of field sales and home office rotational assignments potentially in the following areas:

Marketing, Commercial Training & Development, Market Analysis and Strategy, Managed Care and Customer Operations,

and other business units. The rotation assignments are tailored to provide new hires with challenging and meaningful

assignments, training in both technical and managerial skills and coaching from the Commercial Leadership team. The

Commercial Rotation Development Program gives recent graduates the opportunity to gain a broad perspective on the

core Commercial functions that are critical to the commercialization of Genentech products.

Program Structure:

o Associates will complete 12 -16 month field sales assignments* and two six-month home office assignments within the

Commercial Organization

o Associates will formally report to a manager in each assignment

o Associates will be assigned a senior leader as a mentor for the duration of the program

Training and Development for Participants Includes:

o Formal training integrated with the Commercial Training & Development group

o Informal learning opportunities such as Executive Lunch and Learns

o Program and networking events

o Coaching through a Mentor Program

* Field sales assignment may be anywhere in the United States.

Qualifications

Join a Biotechnology Leader

For more than 30 years, Genentech has been at the forefront of the biotechnology industry, using human genetic

information to develop novel medicines for serious and life-threatening diseases. Today, Genentech is among the

world’s leading biotech companies, with multiple therapies on the market for cancer and other serious medical

conditions.

Our founders believed that hiring talented, enthusiastic people would make Genentech a success. Today, we still believe

our employees are our most important asset. For this reason, we aim to provide employees with a stimulating and

collaborative environment where they can make important contributions to medicine and thrive as professionals.

Commercial Rotation Program Overview

The Commercial Rotation Development Program provides the opportunity for high potential future leaders to gain

exposure to functions that are critical to the Commercial Organization. This is accomplished over an approximate

two-year period through a mix of field sales and home office rotational assignments potentially in the following areas:

Marketing, Commercial Training & Development, Market Analysis and Strategy, Managed Care and Customer Operations,

and other business units. The rotation assignments are tailored to provide new hires with challenging and meaningful

assignments, training in both technical and managerial skills and coaching from the Commercial Leadership team. The

Commercial Rotation Development Program gives recent graduates the opportunity to gain a broad perspective on the

core Commercial functions that are critical to the commercialization of Genentech products.

Program Structure:

o Associates will complete 12 -16 month field sales assignments* and two six-month home office assignments within the

Commercial Organization

o Associates will formally report to a manager in each assignment

o Associates will be assigned a senior leader as a mentor for the duration of the program

Training and Development for Participants Includes:

o Formal training integrated with the Commercial Training & Development group

o Informal learning opportunities such as Executive Lunch and Learns

o Program and networking events

o Coaching through a Mentor Program

* Field sales assignment may be anywhere in the United States.

Qualifications

Preferred Qualifications:

o Education: MBA, PhD, or PharmD within the last 2 years

o 5 years of work experience prior to graduate school in one of the following areas: Biotechnology, pharmaceutical or

healthcare industry. Will also consider experience in consulting, finance, or other related business fields industries

o Strong quantitative and analytical skills

o Demonstrated ability and experience in effectively interacting with Executives and Senior Leaders

o Passion and motivation to advance to leadership level opportunities

o Demonstrated leadership skills and experience

o Exceptional oral and written communication skills; Exceptional presentation skills

o Must be able to travel and relocate

Roche’s Personalized Healthcare (PHC) strategy aims to transform the treatment of disease and improve patient outcomes globally by bringing to bear meaningful data at scale and advanced analytics for drug development and personalized patient care.  Insights into patient and disease heterogeneity as well as clinical outcome will emerge from analysis of high-dimensionality datasets including longitudinal clinical trial and real-world datasets from large cohorts of patients, with deep characterization of individuals using techniques such as whole genome sequencing, transcriptomics, immune system profiling, anatomic and pathology imaging data, and digital approaches to continuous monitoring.  This effort is building capabilities for data and insight sharing; applying advanced analytics to identify novel targets and biomarkers to increase R&D productivity; identifying new methods for characterizing disease states and quantifying disease activity; generating insights to fundamentally change the drug development paradigm; and shaping the internal and external environment to enable value recognition from these insights.

The newly created leadership position of Global Head of Digital Health Platforms will lead a group which partners with other Digital Health groups in the company to advance digital solutions, such as devices and mobile medical applications, to enable development of our therapies as well as more personalized care of patients across a range of therapeutic areas.  Specifically, the Digital Health Platforms group will focus on late-stage development of novel digital biomarkers and endpoints, including the design, conduct, and analysis of analytical validation, clinical validation, and clinical utility studies to meet clinical and regulatory requirements, as appropriate.

The leader will closely collaborate with the therapeutic areas, other Digital Health groups across Roche, as well as Data Science, Advanced Analytics, Medical, Technology, and other subject matter experts within the Personalized Healthcare area and the Research and Early Development (gRED, pRED) organizations, Roche Diagnostics, Pharma Partnering, and Information Technology, to define and execute the strategic direction of Digital Health to transform drug development and patient care.

Key Accountabilities:

• Lead the newly formed Digital Health Platforms function within the Personalized Healthcare group in Global Product Development, developing and driving an emerging and transformative capability of the company focused on innovative and fit-for-purpose Digital Health technologies.
• Drive the development of a visionary Digital Health strategy to support research and development of our molecules and enable personalized patient care and access, in collaboration with the therapeutic area teams and other Digital Health groups within Roche.
• Build a focused, nimble team with deep expertise and experience in late stage development of novel digital biomarkers and endpoints to collaborate with Roche’s network of internal Digital Health experts and practitioners to achieve exponential value in a highly matrixed, multi-cultural global organization.
• Resource molecule and disease area teams and initiatives effectively with internal and outsourced capabilities to deliver high quality, rigorous and fit-for-purpose Digital Health Platforms according to company priorities and opportunities to impact business.
• Guide the design, conduct, and analysis of validation studies required for late-stage development of digital platforms and therapeutics. Originate, review and provide input into documentation to support clinical development and regulatory filings.
• Lead or contribute significantly to functional, cross-functional, enterprise-wide or external Digital Health communities, networks, collaborations, initiatives or goals on knowledge-sharing, methodologies, innovations, technology, IT infrastructure, policy-shaping, etc. to enable broader and more effective use of Digital Health Platforms to support business
• Align and mobilize PHC resources along with internal and external strategic partners to build key capabilities and infrastructure including the potential acquisition of new Digital Health and associated technologies to accelerate implementation of PHC. Identify opportunities and establish strategic partnerships with leading companies and academic institutions.

Key Qualifications and Experience:

• Proven ability to lead innovation and significant change in a leading academic institution or the pharmaceutical, biotech, tech or diagnostics industry to generate value through development of Digital Health technologies, including validation, evidence development for clinical utility, regulatory clearance/approval, and/or commercialization.
• Recognized expert in Digital Health applications, concepts, tools and language.  The ideal candidate is a recognized leader at the confluence of Digital Health technology and science/medicine, with strong familiarity with drug development in multiple disease areas.
• Ability to lead, motivate, inspire and develop diverse, cross-functional teams in a highly matrixed, multi-cultural global environment
• A critical thinker with the ability to analyze possibilities and solutions and make pragmatic trade-offs, as well as a “big picture” innovator who can recognize possibilities and lead creative organizations;
• Entrepreneurial, venture capital, management consulting, business development or similar network thinking experience.

Key Attributes:

• Agile Leader: demonstrated results in providing strategic vision and leading across geographies to optimize the function’s performance and contribution. Proven ability to innovate, manage ambiguity and derive actionable insights from complex data.
• Collaborative: highly effective teamwork and collaboration skills that enable business results through skillful collaboration with others both internally and externally. 
• Achieving Results: aligns organizational objectives and resources to accomplish strategic objectives and financial results.
• Passionate and Decisive Leadership: demonstrates energy, passion, courage, vision and the drive to be at the forefront of a changing and competitive environment for the benefit of patients, our people and the business. Demonstrated competence in thinking strategically, analytically and innovatively.  Able to quickly and creatively analyze and provide solutions to complex challenges.
• Commitment to people development: proven compassionate and patient mentor who leverages strengths and addresses areas of development in team members, enabling broad scaling of impact and promotion of a culture of trust and support.
• Strong and Influential Communicator: exceptional influencing skills that demonstrate strong thought partnership and create effective relationships with internal and external stakeholders, patient advocacy groups, payors, regulatory bodies, and academic institutions. 
• English language fluency both written and oral.
• Ability to travel up to 25%

*LI-PD-HB

Genentech has an exciting opportunity within the People Analytics Strategy & Solutions team for a high caliber Solutions Strategist (SS). You will be a liaison to internal business clients and the People Analytics team playing a critical role to build customer relationships, delight customers, drive adoption of existing People Analytics tools and services, and support the development of the future pipeline of People Analytics. You will work very closely with technical People Analytics team members and build long-term business relationships that create alignment with business and analytics outcomes. The SS partner is a high impact, very visible role across Genentech.

About the People Analytics Team

The People Analytics team loves data and automation. We value being a top-notch organization with a strong data and engineering culture. We hold equally high standards for people, data, code, and systems. We value learning and growth (and not being bored) and seek others who also do. We strive to create a team of diverse, well-rounded, communicative people who enjoy collaborating, can trust and rely on each other, and ultimately succeed together. We appreciate that we've built a reasonably sized, highly effective team so far (10 staff) and strive to be a great place to work.  The team has two departments: Data Science & Engineering which builds data science models and tools and the Strategy & Solutions team which focus on customer delivery and internal process quality. The team integrates 3rd party platforms such as Visier and Glint with custom developed applications. The team reports to the CHRO of Genentech and supports the Genentech and Roche organization.

The People Analytics Solution Strategist will report to the Head of Strategy & Solutions. Your key responsibilities will be:

Key Responsibilities: You will engage with internal businesses across Genentech to advertise, scope, deliver, and drive adoption of People Analytics tools and services.

• Deeply understand customer needs, People Analytics offerings, and capabilities of HR data and infrastructure

• Delight customers and partners by providing pathways to improve people and business outcomes

• Increase adoption of existing People Analytics solutions by building ongoing relationships with business partners and contributing to stakeholder’s success

• Develop business requirements and business cases for new solutions by working together with business stakeholders and People Analytics team members

• Establish shared vision and goals for solutions and ensure that these are communicated and understood by the team

• Program manage key projects by developing approaches, pro-actively identifying risks, correcting plans, and problem-solving to ensure programs on track

• Contribute to the growth of People Analytics by actively contributing the team overall, working alongside technical and non-technical staff, and identifying strategic opportunities for People Analytics growth and expansion

Who you are

In hiring new employees, we look for people who are also inspired by our mission and who would fit in well with the collaborative, scientifically rigorous, and entrepreneurial spirit of Genentech’s culture. Because we know that employees are critical to bringing novel medicines to patients, we are dedicated to remaining a great place to work by providing employees with programs, services, and benefits that allow them to bring the best to the business and to their personal lives. 

Requirements:

• Bachelor's degree in quantitative field such as economics, statistics, mathematics, physical sciences, business, or related field

• 8+ years of quantitative consulting experience.  Business analyst, Business Management Consultant, Continuous Process Improvement, Pre-sales technical and customer roles, or implementation experience

• Experience working within a large corporate environment with strong Business acumen to understand corporate business levers and the need for pragmatism

• Experienced at question based consultative positioning or selling.  Guiding customers to technical solutions through listening, feedback, and questions.

• Effective at problem solving & critical thinking by understanding difficult problems and constructing appropriate solutions

• Polished speaker and communicator with the ability to evangelize data-driven solutions at various levels within a large organization. Capability to tell stories using data, visualizations, and technical insights

• Open, curious, and effective at listening.  Seek to learn regularly through asking questions and soliciting feedback often.

• Teamwork and collaboration with cross-functional teams that include a variety of technical and non-technical capabilities

• Self-directed and independent. You regularly check-in with team-mates and your manager but you enjoy autonomy

• Exposure to key analytics topics in areas such as statistics, data modeling, visualization, data architecture, data management

• Proven ability to analyze, design, and optimize processes through relevant methodologies such as Agile, Lean, and Six Sigma

• Ability to deal with ambiguity and react quickly and strategically to changing priorities with incomplete information

• Technical Project Management experience

• Experience with SQL and working with large datasets

• Experience with data science and visualization tools such as R, python, tableau, plotly

• Technical and scientific acumen

• People or HR data analysis acumen

• Survey Design

• Experience with HRIS and applicant tracking system

Preferred Requirements:

• Master’s or PhD in business, economics, statistics, mathematics, physical sciences or related field

• Relevant work experience in the pharmaceutical (pharma) or biotech industry with drug development

• Experience in HR

• PMP certification

• Experience with Workday

• Experience working with or in support of diverse communities

Role is based in South San Francisco; This position is not eligible for relocation.

The Clinical Safety Associate I (CSA I) supports the drug safety staff in the day to day operational job responsibilities, including but not limited to the collection, clinical review, evaluation, and processing of adverse event (AE) information received by US Drug Safety. The CSA I supports study management activities in collaboration with other functional groups and supports the US Drug Safety Case Management Manager (CMM) in all activities. All responsibilities are performed under the direction of the CMM.

Key Accountabilities:

- Completes drug safety monitoring and tracking in a timely, thorough and accurate manner in accordance with pharmacovigilance (PV) and related standards, regulations and Genentech/Roche Standard Operating Procedures (SOPs) (~60% and as per business needs)

- Reviews, evaluates and verifies potential AE information to determine required action per internal policies and procedures

- Provides medical assessment on all cases for seriousness / validity / causality and conducts quality review of all cases (as applicable) including medical review of information entered in the safety database for completeness and coherency

- Performs follow up (e.g. Drug specific questionnaires / Pregnancy reports etc.) for all reported cases (as applicable) based on their assessment (i.e. Medically significant, non-serious, invalid etc.) to capture complete medical picture of an ICSR

- Medically reviews ancillary documentation accompanying Individual Case Safety Reports (ICSRs) and identifies medically relevant safety information for incorporation into the Global Safety Database

- Demonstrates understanding of appropriate labeling documents for Genentech/ Roche molecules and products and performs labelling assessment for AE(s) received using clinical knowledge

- Identifies and collaborate with external stakeholders for Antibody testing requests

- Responsible for identifying ICSRs requiring expedited safety reporting to Health Authorities. (~5%)

- Responsible for review and implementation of internal Manuals, global / local safety SOPs / Work Instructions (applicable to USDS). Identify the need for creating additional or updating existing local Guidance Documents including but not limited to training matrix and identify appropriate target audience for training assignment. (~3%)

- Demonstrates a general understanding of protocol management in accordance with PV related standards, regulations and Genentech/Roche Standard Operating Procedures (SOPs) to support the protocol review process for supported/ funded studies (~10%)

- Perform Post Authorization Safety Assessment (PASS) classification for all Genentech /Roche supported studies based on medical knowledge and European Union (EU) regulations

- Assists in reviewing Safety Data Exchange Agreements (as applicable)

- Participates and supports the Supported Research Team (as applicable)

- Assists in AE reconciliation and/or Case Transmission Verification (CTV) activities (as applicable)

- Acts as single point of contact for safety related issues

- Acts as Safety Liaison between Safety Science and Supported Research Team

- Oversees Safety related activities for assigned Genentech/ Roche Product(s) managed by US Medical Affairs to include (~10%)

- Demonstrates advanced knowledge of the safety profile to include comprehensive working knowledge of appropriate labeling documents for assigned Genentech/ Roche Product(s)

- Communicates and updates Team of any process related issues/ concerns

- Acts as single point of contact for safety related concerns

- Acts as Safety Liaison between Safety Science, Supported Research Teams (SRT) and Medical Team

- Responsible for medical review and updating of safety sections for documents e.g. pregnancy letters and notify appropriate stakeholders of any changes in executive summary of aggregate reports

- Assist in implementation of Risk Management Plans (RMP) / Risk Minimization activities or Risk Evaluation and Mitigation Strategies (REMS) for assigned molecules / products

- Assists in projects under the direction of US Drug Safety management or project lead (~10%)

- Contribute to the preparation and development of Drug Safety presentations for internal/external stakeholders as applicable (~2%)

- Liaise with Compliance and Training (CAT) / Business Operations Analytics and Market Research and Patient Support (BAM) teams within USDS to ensure all processes are implemented

- Supports the onboarding and training of new personnel

- Provides support during audits and inspections

- Acts as Subject Matter Expert (SME) for safety related activities within Global Safety Database per Genentech/Roche SOPs

Competencies Identified for Success:

- Demonstrates capability to comprehend medical information

- Works effectively, independently and collaboratively

- Strong organizational skills, detail oriented and adapts in a fast paced, changing environment

- Demonstrates ownership, initiative and accountability

- Excellent communication skills, both written and verbal

- Ability to prioritize tasks in a timely manner

- Ability to interact effectively in a multifunctional, multidisciplinary team setting

Qualifications

Education, Experience, and Other Requirements:

- Health Care Professional degree (e.g. RN/BSN/MSN, NP, PA, RPh/ PharmD/ B.Pharm or MD) (Required)

- Minimum 1 to 2 years of clinical or Safety related experience (Preferred)

- Writing experience; science/medical writing (Preferred)

- Computer proficiency (Required)

- Able to travel as per business needs

We are seeking a Sr Scientific Researcher in the Oncology Biomarker Development group within Development Sciences. The successful candidate will be involved in cross-functional project teams, and will play a role in reviewing and assessing the relevance of available biomarker data from clinical studies and will develop and assess scientific questions. He/She must be able to work in a collaborative environment and have flexibility in order to focus on high priority goals of the department and program teams. 

Job Responsibilities:

• Aid in the generation and analysis of large-scale, genomic, phenotypic, and molecular data from internal and external sources.
• Play a role in designing, developing and implementing biomarker strategies for identification of patients more likely to benefit from cancer therapy.
• Work with clinical scientists to implement and coordinate sample collection and analysis in clinical studies.
• Write, review and coordinate biomarker plans in clinical trial protocols, regulatory documents and collaboration agreements.
• Collaborate with internal and external scientific experts to build a disease strategy and identify novel biomarker strategies
• Establish, track, and maintain relationships and data exchange with collaborators.
• Can independently design and carry out experiments and/or data analyses that address significant drug developments questions.  Designs subsequent experiments and/or data analysis plans upon interpretation of data. 
• Develop new methods to address project needs, adapting them to their own needs or developing new protocols themselves. Serves as a resource for state-of-the art practice in areas of expertise
• Play a significant role in the accomplishment of departmental/team goals, that directly impact significant drug development decisions and milestones.
• Outstanding record of accomplishment in his/her field as evidenced by co-authored or primary authored internal technical reports, patents, manuscripts or regulatory documents such as IBs, INDs/CTAs, NDAs/BLAs, and responses to regulatory questions.
• Broad use and application of current theories and principles of Oncology and Immunotherapy, use of techniques of the relevant areas of science, drug and assay development.
• Effective communicator of ideas, project goals and results. Organizes and independently presents work at department, company and/or and project team meetings Presentations are clear and effective.
• Effective written communicator of ideas and results.  Independently completes internal technical reports and may be a co-author or primary author and manuscripts.  Writing requires little revision, and authors documents independently and of high quality. May independently contribute to regulatory submissions as appropriate.   May edit and review internal reports written by others.
• Actively participates, Demonstrates and fosters teamwork at the group, department, and team levels.  Represents department in team meetings. Acts as a resource within the department in a recognized subject or technology.
• Defines approaches and expectations to achieve pre-defined goals to team. Provides timely feedback.  Anticipates resource needs.

Candidate must have:

• Bachelor’s degree or Master’s degree and >6-9 years of work experience in related field, OR Ph.D. degree with optional postdoctoral experience 2-4 years of work experience in the related field.
• Outstanding scientific and organizational skills are a must.
• An interest in clinical development and oncology is required.
• Excellent verbal and written communication, and presentation skills.
• Independent and critical thinking and the ability to make data supported decisions.
• Familiarity with methodologies and platforms used for analyzing high-content NGS data. Contribute in the strategic development of personalized medicine in oncology.

*LI-gRED-NN2

The Clinical Compliance Manager is responsible for activities related to GCP Quality Management System (QMS) oversight, audit, and inspection follow up (CAPA) and will support readiness activities in the Early Clinical Development (ECD) organization. Coordinating closely with QCO members this position provides expertise and support in all continuous improvement activities. This position will also partner with key internal business stakeholders and work cross functionally on continuous improvement activities to drive effective, compliant, and sustainable solutions/ outcomes. Incumbent will apply quality management and continuous improvement theory, technical principles, expert judgment proactively assist the business in the identification of potential risk and lead activities to ensure mitigation and improve ECD compliance and enhance performance of key ECD activities. Core to these activities will be the ability to effectively manage projects and foster effective interdepartmental and cross-functional partnerships.

General responsibilities include but not limited to:

• Collaborates with members of the QCO on the implementation and maintenance of the ECD Functional QMS in alliances with the Quality principles outlined in the ECD Quality Plan and QMS Handbook.
• Serves as a technical subject matter expert (SME) regarding QMS in support of departmental functions.
• Develops, modifies, and utilize tools to track and trend areas of deficiency, potential compliance issues, and clinical trial quality.
• Supports process improvement initiatives and prepares/analyzes quality metrics.
• Partners with assigned management and teams to track and report metrics
• Produces routine reports and status updates for management and leadership as requested
• Works with stakeholders to develop solutions and corrective actions to remediate gaps in identified areas of deficiency such as process improvements and/or training
• Assists in the revisions of procedural documents to drive and support in-house continuous improvement including streamlining processes and maintaining GCP compliance
• Manages follow-up within the Clinical organization on all audits, inspection responses, commitments, post-inspection activities, and implementation of corrective and preventive actions (CAPA) and monitoring established controls after implementation.
• Participates in and supports internal audits and regulatory authority inspections, as required.
• Assists in the planning of compliance assessments including but not limited to vendor/contractor qualification when requested
• Participates in strategic, proactive planning of organizational activities, as required, with the goal of providing compliance expertise and to help ensure monitoring is efficient.
• Provides day-to-day support, and problem-solving expertise to applicable business partners to ensure business operations are conducted in full compliance with all relevant policies and procedures.
• Supports functional QCO objectives including risk assessment related initiatives that have a cross-functional and/or global impact as it relates to a critical compliance issue (s)
• Participates in department trainings, events and initiatives as required

Skills & Competencies:

• Applies deep understanding of GCP ICH, relevant Roche-Genentech, Early Clinical Development, Quality & Compliance Office & sub-function knowledge (e.g., policies, processes, events, tools and systems).
• Practical applications of Quality Management System of concepts, tools and regulations.
• Prioritizes and efficiently allocates time and attention, works in a structured manner and utilizes systems and tools to optimize own efficiency, follows through on deliverables by providing status updates and meeting expected deadlines.
• Identifies opportunities to improve processes.
• Applies good compliance practices, fiscal discipline, and environmental consideration in conduct of duties.
• Develops and maintains effective relationships at all levels internally and externally
• Addresses conflict constructively in an atmosphere of openness and trust
• Works effectively as individual contributor and team member in supporting functional and cross-functional projects.

Requirements/Qualifications:

• BS/BA degree with 10 years of pharmaceutical industry experience in drug development.
• Minimum 5 years directly related experience supporting drug development in a quality/compliance function /applicable compliance field.
• Knowledge of clinical drug development regulations and ICH GCP.
• Knowledge of QMS and CAPA related tools or systems is required.
•  Clinical Study Management, monitoring or audit experience is an asset
•  Experience with health authority inspections and inspection readiness activities preferred.
• Strong personal leadership with demonstrated competency interfacing with senior leaders is required
• Working knowledge of applicable US FDA, EU and ICH regulatory requirements and guidelines as applicable to clinical research.
• Excellent communication skills:
• Listening, interpreting and summarizing information
• Clear and concise verbal communication
• Professional and concise written communications –exceptional attention to detail
• Strong organizational skills, with the ability to effectively prioritize and manage multiple projects and tasks, with attention to detail.
• Strong interpersonal skills and the ability to assist personnel in a matrix organization, ability to proactively resolve issues in a diplomatic, flexible, and constructive manner.
• Highly ethical, self-motivated and self-directed; works effectively independently as well as in a team environment.
• Strong project management skills: MS Word, Excel, PowerPoint, Microsoft Project, Visio, Google applications.

Provides analytical and specialized administrative support to relieve executive, administrative, and line and staff managers of complex details and advanced administrative duties. Executes special or continuous research and data analysis tasks. Analyses problems, determines approach, compiles and analyses data, and prepares reports/recommendations. Coordinates activities between departments and outside parties. Contacts company personnel at all organizational levels to gather information and prepare reports. Work is generally of a critical or confidential nature. Assignments may be found in various functional areas.

As a core member of the Roche Scientific Infrastructure (RSI) team, the Data Management Engineer will be responsible for developing and maintaining all aspects of the data management environment, including meta data management, indexing, tiering and archiving software solutions. Working closely with other members of the RSI team and Infrastructure Services the successful candidate will apply their experience and knowledge, partnering with the storage operations group to develop and deliver an effective, scalable, solution for scientific use at Roche.

The successful candidate is expected to be familiar with multiple platforms including NAS, block/attached, tape/optical with deeper expertise in object storage technologies. You would be responsible for contributing to the evolving development and use of object storage and associated software management solutions providing technical consultancy to ensure effective long term utilization of tiered managed storage.
 

Responsibilities:

• Contribute to the strategy and engineering of the data life cycle management and tiering RSI service and overseeing the operation of the service.
• Consult and partner with scientists to modify and optimize their workflows to efficiently manage data, tiering it for performance and long term discovery and use.
• Responsible for engineering and maintaining the API interfaces for the data life cycle management and tiering RSI service including the store, retrieve, index, search and archive capabilities (e.g. iRODS, samverna, mediaflux, etc.). 
• Dedicated transfer protocols (e.g. aspera, zettar, etc) to ensure Data Lifecycle Management services API’s are performant at scale and over long distances.
• Work closely with other members of the RSI team to ensure that all data managed by the data life cycle management and tiering RSI service can effectively and efficiently be accessed by all the other RSI services (cloud, container, HPC) and integrate with other core services (network, Identity & Access Management, automation).

This position is not eligible for relocation.

Qualifications:

• Bachelor’s degree (advanced degree preferred) in a relevant field of technology, science or business.
• 5 to 10 years’ experience with engineering storage systems and their integration and use in scientific environments.
• Experience in one or more object storage technologies and familiarity with at least one meta data management technology.
• Experience in tuning and optimizing high volume RESTful store/retrieve operations on high bandwidth/high latency networks.
• Experience in one or more scripting languages (Python, Ruby) used to automate data manipulation operations as well as definition languages (e.g. YAML/JSON) for maintaining configurations and data catalogues.
• Familiarity with one or more high performance data transport protocol (gridFTP, aspera, zettar).
• Demonstrated passion for excellence and ability to partner and deliver exemplifying the Roche Leadership Commitments

#LI-CG-MT1

Purpose:

Maintain the site’s Right to Operate and enable excellence in manufacturing by providing technical support to the production organization that results in safe, high quality, and continuously improving production.

• Continuously monitor, analyze, optimize, and ensure validation of ongoing operations (production equipment, automation, and production and cleaning processes).
• Anticipate, respond to and permanently resolve issues that arise during production
• Partner with external and internal functions to transfer, implement, validate, file, and license new products/processes and maintain existing products/processes.

Key Responsibilities

Leadership & People Management:

• Create an environment of strong team spirit, timely and effective communications, sense of urgency, high motivation and inspire teams to achieve goals in the immediate and longer term.  Be an active and visible change agent, promoting flexible and open mindsets to new opportunities.
• Establish strategic goals and objectives and maintain full strategic responsibility for the MSAT organization.
• As a site leadership team member, drive collaboration within site and across network activities, cross-functional planning, and decision making.
• Accountable for overall budget and financial performance of the MSAT organization.
• Proactively promote positive Safety Culture and cGMP operating principles.
• Embody PT lean leadership principles and methods while fostering a continuous improvement mindset

Technical:

• Ensure Right to Operate through compliance with cGMP and regulatory requirements applicable to the department
• Direct areas of responsibility:
• Validation: Own, execute and improve the validation program for equipment, processes, and cleaning, and ensure compliance with PQS and HA requirements.  Represent Validation program during HA inspections.
• Automation: Own, integrate, maintain and improve all production automation platforms at the site, and ensure compliance with PQS and HA requirements.
• Tech Transfer: Partner with global and site functions to specify, transfer, file and license new products/processes in the plant.
• Process Engineering: Establish oversight to ensure production is performed in conformance with license requirements, cGMPs, and global Health Authority expectations, and represent state of compliance during Health Authority inspections.  Drive continually monitoring of process to implement continuous improvement process
• Technical Services: Respond to and proactively identify issues, determine root cause, and solve forever: Develop, prioritize and drive continuous improvements and other readiness operational maintenance activities that reduce safety risks, operational costs, lead times, and scrap/discrepancy rates across all aspects of production. 
• Manufacturing Support: Provide technical support to manufacturing organization that includes process and product monitoring, master data and documentation management, compliance to Roche quality systems, and other readiness operational support activities
• For specific sites:  Pilot Plant Operations: Build and maintain pilot plant operations to support Make-Assess-Release activities, tech transfers, and continuous improvement of the production plant.  Launch and PTD partner.
• Operate as one network: Partner with global MSAT teams and network peers at other manufacturing sites to share and adopt best practices across the network that drive continuous improvement in all technical aspects of production.
• Serve as a core member of the relevant Technical Council, provide site contributions to network technology roadmaps, ensure funding and execution of assigned projects on the respective site level.

Requirements:

• Bachelors Degree required (science or engineering). Graduate or higher-level Degree is preferred.
• 12 or more years’ work experience in the pharmaceutical or related industry
• 8 or more years’ people management experience
• 4 or more years’ relevant engineering or project management experience in the pharmaceutical industry and/or a cGMP environment
• Extensive experience with start-up and validation of manufacturing equipment, utility and process systems, including requirements for documentation and testing
• Expert knowledge of clean room or classified area design/requirements
• Deep process, equipment, automation, validation and technical knowledge
• Possesses strong verbal and written communication skills and the ability to influence at all levels.
• Builds trustful and effective relationships
• Able to think strategically and translate strategies into actionable plans
• Takes responsibility, drives results, and achieves expected outcomes

Job facts:

Are you interested in working in an exciting and challenging position that will work across functions, across companies and across the world?

The Industrial Hygienist develops, coordinates, implements, and evaluates companywide health and safety programs.  This role will coordinate activities with manufacturing affiliates across the US, Canada, and Germany for the development, implementation, and sustaining the Roche Diagnostics global product safety, health, and environmental review process.

The opportunity:

• Conducts industrial hygiene investigations to anticipate, identify, evaluate and control exposures to chemical, biological, physical or ergonomic factors of employees or operations. Assesses safety and health risks associated with equipment, materials, processes, facilities, or personal abilities in order to identify and control hazardous conditions or actions that may cause injury, illness or property damage. 
• Manages various health and safety programs to ensure that the operations out of Indianapolis complies with applicable regulatory and company requirements, utilizes best-industry practices to identify and manage risk, and conforms to company directives and standards.
• Serves as the primary resource for assigned programs, providing related guidance and support to business areas, colleagues and management through training courses, inspections, written programs, and SHE website content.  Such program areas responsible for but not limited to: chemical hygiene, hazard communication, indoor air quality, respiratory protection, personal protective equipment, noise, and lasers.
• Direct contact with the Mannheim, Germany affiliate for the development, implementation, and sustaining the DIA global process for Safety Data Sheet development
• Provides support services responsibilities for US and Canada manufacturing affiliates around development of Safety Data Sheets that includes coordination of hazard communication for labels, classification of dangerous goods for shipping, and collaborating with site environmental on needs related to import/export and disposal regulations. Assists with government regulatory agency interactions relative to regulated health and safety programs, including reporting, notification, facilitating regulatory inspections, and ensuring closure of corrective actions

Who you are:

• Bachelor’s Degree from an accredited 4-year college or university with a major in physical science, life science, engineering, safety, industrial hygiene, or other relevant field.
• 5+ years (10+ years highly preferred) of progressive experience within an industry sector such as: automobile, diagnostics, chemicals, pharmaceuticals, oil and gas industry, or other relevant industries or a Master’s degree with 3+ years of experience.
• Professional certification such as a Certified Safety Professional (CSP), Certified Industrial Hygienist (CIH), Professional Engineer (PE), or ability to obtain.
• Knowledge, interpretation, and application of laws and regulation and the ability to identify issues and make sound decisions under conditions of risk and uncertainty.
• Ability to attain program specific certifications (e.g. industrial equipment, fire protection, confined spaces, fall protection, etc.) as needed. 
• Ability to operate chemical, biological, and physical hazard sampling equipment.
• Highly proficient project management skills, team building, and organizational ability to implement new projects and programs in a timely and effective manner and to arrange competing tasks into logical steps.
• Strong written and verbal communication skills:  written (business e-mail, technical documents, programs) and verbal (meeting leading, presentation, and training) 
• Strong interpersonal and negotiation skills necessary to develop and maintain smooth, cooperative working relationships and to drive change across business areas.
• Requires use of Microsoft Office suite packages
• SAP knowledge highly desired
• Must be able to learn and develop new areas of subject matter expertise. 
• Ability to travel approximately 10%

Please note this is a Night Shift position

Under the direction of the Filling Production Manager, the Aseptic Operations Supervisor will be accountable for Aseptic Production Operations of liquid or lyophilized products, including capping, tray-off and Automated Inspection.  Including overseeing drug substances thaw/compounding process and small part autoclaving and sterilization.  In addition to managing the responsibilities below, the successful candidate will need to demonstrate the following traits.

• Able to collaborate with both plant and corporate organizations seamlessly
• Has the passion and drive to develop and maintain a LEAN culture dedicated to providing the best results for our internal and external customers
• Embraces World Class principles and behaviors
• Is constantly in search of the most creative and innovative solutions to maintaining the highest levels of productivity
• Is able to provide the leadership necessary to maintain a high performance culture

  Responsibilities:

• Ensure work environment meets Genentech and industry standards
• Create and maintain a safety culture that delivers injury and incident free operations
• Drive achievement of departmental safety performance targets and manage operations so that all departmental, functional and site objectives are met
• Reinforce safety practices/behaviors throughout the shift
• Provide oversight and support to ensure safety improvement initiatives are consistently identify and implemented
• Ensuring that all shift personnel have applicable safety training requirements assigned and completed
• Ensure the facility is always regulatory inspection-ready
• Participate in the development of quality goals and oversee operations to ensure targets and objectives are achieved
• Review trend data to ensure quality compliance and correct negative trends as required
• Reinforce quality practices throughout the department
• Provide oversight and support to ensure adequate quality improvement initiatives are appropriately identified and implemented in a timely manner
• Maximize production output and labor efficiency while meeting required safety and quality levels
• Manage operations to ensure that production, productivity, and financial targets and objectives are met
• Ensure business processes are followed and improved to deliver production performance at Class A levels
• Maximize equipment utilization and Overall Equipment Effectiveness (OEE)
• Apply operational excellence tools to define standard work, reduce process variability and steadily deliver measurable efficiency gains
• Ensure that Continuous Process Improvement teams are supported, trained and facilitated
• Manage the execution of the production schedule and shop order sequencing to optimize use of available capacity
• Maintain data and transactional sources required to support capacity models to understand real time capacity utilization and capability
• Comply with all company policies and procedures related to personnel management
• Manage and mentor the performance planning process for all direct reports to ensure their success Coach and develop leads, specialists and technicians via effective development planning
• Coordinate shift level hiring and staffing plans
• Complete all required training activities (i.e., safety, cGMPs, technical skills, processing operations, etc)
• Ensure lessons learned or best practices are shared across the department
• Leverage knowledge to maximize organizational effectiveness
• Identify and manage the development and implementation of novel approaches to solving complex technical problems while maintaining required levels of safety, quality (including regulatory compliance), and production
• Actively manage shift labor, overtime and spending to within the approved budget on an ongoing basis
• Review and approve manufacturing documentation including batch records and SOPs. Review and support closure of discrepancy records
• Participate in strategic planning, objective self analysis for compliance, safety and quality risks, and analysis of operational strengths, weaknesses, opportunities and threats

  Requirements/Qualifications:

• Bachelors degree in a science or engineering discipline or equivalent
• Demonstrated ability to manage people and projects. Ability to work with internal teams, partners, suppliers and customers
• Excellent written/spoken communication and interpersonal skills

  Desired:

• Possess a minimum of 5 years of progressively responsible experience in pharmaceutical manufacturing and specific experience in parenteral manufacturing
• Current understanding of FDA and EMA guidelines, cGMP’s for Manufacturing Parenteral Drug Products, including validation requirements
• Operational Excellence and Industrial Engineering skills
• Proficiency with validated change management, discrepancy management, inventory management, and production control systems

  Currently this position is on D Shift, which is a compressed night shift on the back half of the week. Work hours for this shift are currently Wed, Thursday, Friday and every other Saturday night from 18:00 to 06:00.

  The shift is subject to change based on the needs of the business.

Genentech is seeking a highly adaptable individual with strong technical expertise and a passion for delivering innovative solutions to join the Process Development Engineering (PDE) function within PTDUO (Pharma Technical Development U.S. Operations & Engineering) at our South San Francisco, CA site. As a member of PDE, you will have the opportunity to implement technologies in clinical manufacturing and to drive long-term technology and engineering initiatives related to the needs of both Process Development and Manufacturing.

Members of PDE are tasked with innovating and delivering technologies for Process Development and Manufacturing. A successful candidate will closely collaborate with customer groups, quickly learn new technologies, rapidly prototype, and deliver solutions that continuously advance the capability and efficiency of Process Development and Manufacturing. This requires a combination of adaptability to our fast paced environment, excitement for learning,  delivering meaningful solutions to our business, passion for Single-Use technologies and forthcoming communication skills.

PDE is comprised of a group of engineers with diverse skill sets. The department work leverages engineering principles, but specific technology areas evolve as required by the business. Current areas of focus include data management, data science, automation, new technology implementation and process engineering. This position will collaborate with multi-disciplinary team members to design, develop and implement novel single-use technologies and equipment for end-to-end integrated continuous biomanufacturing facilities of the future. The successful candidate will have the opportunity to add significant value in defining the future of drug manufacturing processes.

Responsibilities

• Tackle technology projects with passion and urgency. Leverage existing technical experience and rapidly learn new technologies to meet business needs.
• Provide exceptional customer service, technical support, and engineering services to customers and partners in Process Technical Development (PTD) and Manufacturing
• Collaborate with partners and customers within PTD and Manufacturing global network to ensure PDE is developing impactful technical solutions that meet customer needs.
• Innovate and challenge conventional assumptions to drive change and bring new technologies/projects to enhance our manufacturing operations (i.e. maximize success rates, reduce recurring discrepancies, increase capacity/productivity, increase levels of safety and/or compliance)
• Participate in internal and external collaborations that take calculated risks on new technologies that may provide the business with a competitive advantage in the future
• Influence the industry through participation in external communications, both written and verbal
• Support an engaging and fun workplace for all employees that fosters full engagement and collaborative problem solving

Qualifications

• B.S. in biochemical engineering or related discipline with 5-10 years related experience or a M.S. or Ph.D with equivalent combination of work experience and education.
• Significant technical expertise in one or more areas related to process development and/or manufacturing of biologics.
• Prior experience developing or implementing single-use technologies for flexible manufacturing
• Ability to work seamlessly with a diverse team of engineers to design and develop technology investments in collaboration with customer groups.
• Demonstrated record of technical innovation, including the ability to identify and implement novel solutions.
• Strong verbal and written communication skills. Must be able to communicate complex technical content and influence peers and leadership.
• Candidate must be comfortable with working in a dynamic, innovative and change-oriented environment.
• Prior experience working on integrated, closed and fully continuous production platform is a plus