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Date Job Title Job Level Location
8/21/18 Head of Human Resources Manager with direct reports Singapore, Central Singapore

Provide strategic direction in creating an effective and integrated strategy for advancing the business through human resource planning, employee relations, talent management, staffing, HR operations, performance management, organizational development, leadership development, compensation and benefits.

8/21/18 Manufacturing Technical Specialist II/Engineer I, Upstream Pilot Plant Individual contributor Oceanside, California

Summary

Responsible for providing scientific and technical support to GMP Manufacturing Operations in a multi-product, large scale, automated biopharmaceutical facility. This includes activities related to safety, compliance, quality, targeted innovation, and plant performance and success. Deliverables include but are not limited to implementation of targeted new technologies and procedures, assessing, evaluating and providing immediate corrective actions for GMP discrepancies and intra batch process monitoring, analysis and reporting. May troubleshoot equipment and systems; develop new equipment requirements and operating parameters, providing factory acceptance testing and validation support. Investigates operational and process discrepancies, implements corrective action, and develops and validates manufacturing improvements.

Job Responsibilities:

  • The Engineer I will be an integral member of the Oceanside Laboratory and Pilot Plant (OLP) upstream team. 
  • Perform required operations at pilot and small scale.
  • Execute and lead small/pilot scale studies in close collaboration with customer and all involved groups to support: make-assess release, tech transfers, and network.
  • Automation and Engineering Solutions and act as a member of a high functioning team. These tasks will include those associated with coordinating and performing operations (i.e. set up, inoculating, maintaining, harvesting and cleaning equipment/bioreactors)
  • Experiment data recording, collection, and analysis. He/she should be able to present information timely, clearly, and confidently. 
  • Lead technical transfers of phase III molecules from late stage process development to commercial launch scale and commercial scale to commercial scale: verification of scale-down model and site dependent/facility fit studies.
  • Lead close communication between late stage process development and molecule recipient commercial site.
  • Lead technical teams in support of site investigations and commercial make-assess-release.
  • Lead scale up of processes:
    • ability to generate feedstock for downstream pilot-scale studies
    • harvest process parameter range studies (pilot scale)
    • characterization at pilot scale to ensure optimal operability at large scale: consistency runs (thaw to formulation) and verification of manufacturing process robustness at pilot scale.
  • Liaison between Operations and the Pilot Plant customers.
  • Offer technical/operational expertise, attentive customer service, and work as an integral partner in the successful execution of experiments.
  • Provide and spearhead troubleshooting assistance with equipment and processes
  • Trainer for other technicians and support personnel.
  • Specific focus on continuous process improvement, new technology/process implementation and will design experiments and apply theories to execute projects. 
  • Lead and manage independent projects as well as participate on cross-functional teams as a representative of the laboratory and pilot plant upstream team.

Requirements:

  • The ability to work independently under limited supervision
  • Coordinating and performing operations and tasks associated with cell culture experiments at pilot and small scale.
  • Having a solid understanding about CHO processes and experience with analytical instruments is preferred.
  • The ability to display a strong focus on collaboration, customer service, attention to detail, analytical ability and intellectual curiosity.
  • Must be able to work on a team with diverse skills and objectives and interact with customers in a productive manner. 
  • Operational and technical troubleshooting skills and creative, flexible problem solving skills are required. 
  • Project coordination/management skills are needed and must have demonstrated the ability to take a project from idea inception to implementation.
  • Interfacing with customer groups by seeking opportunities for collaboration, and proactively communicating and presenting information timely, clearly, confidently, and concisely and offer relevant views and information to impact decisions.
  • High level of demonstrated initiative, exhibit flexibility in work approach, and demonstrate strong follow through and accountability.
  • Must be self-driven to learn and keep current with new technology developments and be organized and capable of multitasking, have effective problem solving abilities, and have demonstrated reliable decision-making. 
  • Demonstrates flexibility to ensure that all cell culture operations at pilot and small scale are supported to meet run schedule demands while managing other areas of responsibility, such as project support.
  •  Bachelor's, Master's, or Ph.D. degree in Chemical/Biochemical Engineering or Life Sciences.
  • Must have 4 - 6 years of hands-on cell culture experience and a familiarity with pilot plant and lab techniques and processing. 
  • Mechanical aptitude, knowledge, and experience with computer systems are also needed.
  • Must be able to lift up to 40 pounds

This position is not eligible for relocation.

8/21/18 Mfg. Technical Specialist II/Engineer I, Downstream Pilot Plant Individual contributor Oceanside, California

Job Responsibilities

Summary

Responsible for supporting operations in the Oceanside Pilot Plant and Science and Engineering Purification/Analytical Lab.  Deliverables include but are not limited to: HPLC-based analytics, rapid bioburden/endotoxin, lab scale and pilot scale chromatography, UFDF operations, buffer prep, column packing, equipment maintenance and preparation of technical reports.  May commission new equipment, troubleshoot equipment and systems, develop new equipment requirements and operating parameters, and provide factory and site acceptance testing.  Provide scientific and technical support to GMP Manufacturing Operations in a multi-product, large scale, automated biopharmaceutical facility.  Support process validation through large and small-scale studies, protocol and report preparation, validation sampling, and sample shipments.

Job Responsibilities

  • Will contribute to the daily operations in the Oceanside Process Engineering (PE) pilot plant and/or analytical laboratory
  • Assist with the tech transfer of new products to Oceanside
  • Implement new purification processes and analytical methods into PE pilot plant and analytical lab
  • Perform pilot-scale studies as needed to support commissioning and optimization of the manufacturing scale and purification process tech transfers
  • Perform analysis of in-process intermediates and raw materials using HPLC, rapid bioburden and endotoxin, particle analysis, and small-scale protein purification and filtration for a variety of purposes, including investigations, process validation, process development/ improvement and routine testing.
  • Assist with the factory acceptance testing (FAT), site acceptance testing (SAT), setup, and commissioning of S&E pilot plant equipment
  • Prepare area SOPs
  • Monitor small scale and large scale cell culture or purification processes to identify and resolve complex equipment and process issues
  • Contribute to process validation/characterization efforts, including but not limited to: large and small-scale studies, protocol and report preparation, validation sampling, and sample shipments.
  • Contribute to advances in technological capabilities
  • Provide technical support for all associated Make-Assess-Release activities, including monitoring, trouble-shooting, corrective action and assessment and remediation of discrepant incidents impacting manufacturing materials, methods and equipment.
  • Support implementation of manufacturing continuous improvement initiatives and support of New Product Introduction (NPI)
  • All employees with jobs that require access to the Warehouse must be able to pass the Transportation Security Administration (TSA) Security Threat Assessment (STA)
  • 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.
  • May act as Subject Matter Expert for the purposes of training S&E personnel
  • Embraces open communication, teamwork and transparency by aligning efforts and knowledge sharing
  • Gathers data on campaign material consumption and creates detailed material requirements
  • Communicates changes for site logistics and planning functions to ensure correct inputs for

Job Requirements

  • Bachelor's or Master's degree in Engineering or Life Sciences.
  • 4-6 years experience in relevant field.
  • 2-4 years with Master
  • Proven knowledge and practical experience with core regulatory requirements
  • Demonstrated working knowledge of process control, manufacturing execution and enterprise resource planning systems.
  • Proven management, communication, interpersonal, organizational and project management skills.
  • Demonstrated ability to work as part of a multi-disciplinary team.
  • Demonstrated proficiency in the application of basic manufacturing, engineering, and/or scientific theories, principles, and techniques used in biopharmaceutical manufacturing processes.
  • Ability to interact within and across work groups and with outside collaborators and vendors on technical matters.
  • Demonstrated technical proficiency, leadership, creativity, and strategic thinking.
  • Practical and theoretical expertise in biopharmaceutical manufacturing processes engineering and applied technologies.
  • Strong oral and written communication skills.

8/21/18 Utility Plant Operator / Sr. Utility Plant Operator Individual contributor South San Francisco, California

Genentech’s South San Francisco Production (SSFP) group manufactures medicines that improve the lives of patients around the world.  SSFP is the first cGMP production site established by Genentech and includes facilities, equipment, and staffing to perform end-to-end manufacturing that is scheduled and supported 24 x 7.

SSFP currently has opportunities available for Utility Operators to join the day shift. These positions operate utility systems and subsystems in an FDA regulated environment to ensure:

  • All preventative maintenance is performed in a timely manner and at appropriate intervals
  • Equipment remains in its designed cGMP and/or validated state at all times
  • All equipment operation is in accordance with federal, state, local and company regulations, procedures and policies

Responsibilities include:

  • Manage the day to day operation of plant utility systems; monitor the overall operation and status of the utility systems and submit work notifications for system repairs as needed
  • Ensure/maintain all utility equipment areas in a constant state of inspection readiness
  • Continuously evaluate the operation of all utility systems and utility subsystems; identify specific process improvement needs and provide recommendations for system upgrades
  • Identify training deficiencies, provide recommendations for training and provide training as needed
  • Continuously evaluate all operational Standard Operating Procedures and Preventive Maintenance procedures for accuracy and applicability
  • Provide operational support to Facility Services, Engineering, Manufacturing, and Research and Development
  • Perform Confined Space Entry on an as needed basis
  • Complete preventive maintenance and assigned paperwork in a timely manner following all cGMP documentation guidelines
  • Gather and document appropriate information associated with a System Discrepancy (an event in manufacturing process and/or support system that is outside approved operating parameters or approved procedures)
  • Work with various chemicals, steam, pressurized gases/liquids of various temperatures
  • Work in close proximity to moving equipment
  • Act as point of contact for customer guidance and support
  • Ensure all Utility rounds are completed and missed rounds are documented
  • Monitor Utility work request queue and advancing notifications into work orders
  • Assist in troubleshooting efforts for all Utility equipment that is directly impacting manufacturing processes
  • Attend all required cGMP and Safety training

We are seeking local applicants who possess the following qualifications. The level of the position will depend on the qualifications of the selected candidate.

  • Minimum 2 years of experience in an industrial / manufacturing maintenance role with demonstrated strong mechanical aptitude
  • Completion of a relevant technical school program, or accredited 2-year program, may be considered in lieu of work experience
  • High school diploma or equivalent
  • Technical degree, certificate, or coursework a plus
  • General knowledge of shop tool operation and safety
  • Ability to respond to and evaluate a variety of situations involving mechanical, electrical and systems controls
  • Practical knowledge of equipment maintenance, operation, control and cleaning for process equipment; HVAC/R; clean utility systems; process air systems; waste neutralization systems; bulk chemical and gas systems; RW/Glycol Systems is required for the senior level
  • Working knowledge of electrical switchgear and distribution systems in the medium to low voltage range is also required for the senior level
  • Ability to perform preventive maintenance and equipment servicing according to Standard Operating Procedures
  • Effective verbal and written communication skills including the ability to prepare technical reports and the ability to read and understand Standard Operating Procedures (SOPs)
  • Detail oriented with the ability to demonstrate good record keeping practices
  • Ability to understand and adhere to federal, state, local and company regulations, procedures, and policies
  • Computer skills with the ability to use word processing, spreadsheet, database, and email applications
  • Ability to work safely in an environment containing hazardous chemicals, high and low temperature liquids, high pressure liquids and gasses, steam, and moving machinery
  • Strong interpersonal skills with the ability to work effectively as part of a team
  • Ability to work with minimum or no supervision.
  • Ability to work a regular shift that includes one weekend day, and flexibility to work overtime or a temporarily modified shift schedule to support manufacturing operations as needed

We are seeking local applicants for these positions. Only applicants who reside in the San Francisco Bay Area will be considered. No relocation.

#LI-PTD-JM

8/21/18 Senior Scientific Researcher/Antibody Engineering, Genentech Research Individual contributor South San Francisco, California

The Position

We are seeking a highly motivated Senior Scientific Researcher to join the Department of Antibody Engineering. The successful candidate will work in the development of new antibodies for therapeutic and research applications using molecular biology and protein engineering approaches. The position also has a strong emphasis on developing new technologies for antibody discovery, optimization and engineering using antibody phage display and Next-Gen sequencing of immune and synthetic repertoires. The individual is expected to work in a highly collaborative environment, demonstrate initiative in solving difficult technical challenges and to work simultaneously in multiple projects.

For more information, please see Isidro Hotzel's Sr. Scientist profile on Gene.com: https://www.gene.com/scientists/our-scientists/isidro-ha-tzel.

Who You Are

Requirements include an MS or PhD degree in biochemistry, molecular biology or related discipline with 5 years (MS) or 3 years (PhD) of relevant research experience.

Successful candidates will have expertise in molecular biology, including cloning and mutagenesis, familiarity with concepts of protein biochemistry and structural biology and computational skills for analysis of large datasets.

Experience with protein/antibody engineering and directed evolution methods such as phage display or related methods and analysis of protein interactions by surface plasmon resonance (Biacore) and related methods is a plus. Qualified candidates will have demonstrated ability to rapidly and independently become proficient in new and diverse experimental techniques and have strong oral and written communication skills. Excellent organizational, experimental data recording and time management skills are also required.

#LI-gRED-HB2

8/20/18 (Senior) CSSD scientist Individual contributor Shanghai, Shanghai

Title: Sr. CSSD Scientist

Position type: Full time

Location: SSF, Basel, Welwyn, Shanghai and Beijing

 

Purpose

 

The Sr. CSSD Scientist supports early and late phase development activities as a member of the safety team under the leadership of the SSL providing essential safety oversight and input into all aspects of study management across the entire development portfolio. In the post-market setting, this role contributes to safety science deliverables required to maintain license to operate and to manage and communicate the evolving safety profile. 

 

 

Job Responsibilities

 

?      Represent Safety Science with business process owners on processes executed by Safety Science

?      Responsible for coordination and collaboration with vendors servicing Safety Science

?      Acts independently to manage safety responsibilities on study teams and in activities supporting safety science

?      Trains and mentors more junior members of the safety team

?      Takes on responsibility for more complex deliverables

?      Takes on team leadership responsibility in order to manage and complete projects requiring more coordination and insight for low-medium priority projects

?      Understands how safety activities contribute to development goals and takes measures to maximize safety value to the organization

?      Takes on speaking opportunities and team leadership opportunities

?      Demonstrates independence and high competence in the conduct of all safety science responsibilities

?      Demonstrates behaviors consistent with Roche values and engenders confidence from senior management

 

In collaboration with the SSL:

?      Responsible for individual and aggregate case reporting activities including ICSR case management (medical review) and aggregate reporting (i.e. DSUR, PBRER

?      Responsible for signal detection and management activities including, but not limited to STAR maintenance, ISMP maintenance, and drug safety reports.

?      Contributing to risk management activities including preparation and maintenance of CCDS, labeling document maintenance, risk communications, RMP, REMS

?      Contributing to study management through SMT/PET and document review across the development continuum (early phase to post marketing studies), including PASS

?      Interfacing with business process owners on processes executed by Safety Science

?      Coordinate and assist in responding to Health Authority requests

?      Responsible for supporting processes involving safety science such as the expected terms list, MedDRA baskets, ICF process, etc.

?      Supporting product quality issues

?      Responsible for carrying out activities related to quality system management for safety science

Education, Skills and Experience

 

Minimum:  Bachelor’s degree in healthcare related field or equivalent experience and 3 years of relevant experience.

 

?      Work experience in pharma safety, pharmacovigilance or other related pharmaceutical development area

?      Understanding of GxP and regulated processes and end to end clinical trial lifecycle

?      Strong orientation towards process improvement and cross-functional teamwork

?      Effectively work with remote partners on a global team

?      Excellent communication skills, both written and verbal

?      Perform application of data analysis / statistical methods to evaluate, interpret and present scientific data with clarity

?      (For roles in China) Fluent in Mandarin and English

8/20/18 Competitive Intelligence Manager- GPS Individual contributor South San Francisco, California

Level:  E4

The position can be located in South San Francisco, CA

Self-motivated, dynamic candidates for a Global Competitive Intelligence position within the Strategic Insights and Analysis Department at Roche (SSF)

You will act as a strategic business partner to Lifecycle Teams (LCTs), International Business Teams (IBTs) and other cross-functional and affiliate teams.

You will provide objective competitive assessments and analyses to enable effective and informed decision making.  This includes insights on dynamic market changes on competition and other insights that positively impact business decisions and strategy.

You will also ensure that all competitor information and competitive intelligence is available and easily accessible to key customers, partners and other stakeholders.

In this position, you will be primarily accountable for consistently, effectively:

Acting as a competitive intelligence (CI) expert in developing and delivering regular CI analyses, insights and reporting, including competitor landscapes, threat assessments, strategic workshops, SWOTs, target product profiles of competitor products, etc.

Partnering across Business Insights & Operations, Global Product Strategy and key affiliate teams to understand business strategies and needs and ensure delivery of targeted CI to meet or exceed internal partner/stakeholder objectives

Leading the collection of CI from internal and external sources and undertaking the synthesis and dissemination of this information to support decision-making

Promoting and maintaining best practice CI

Leading the coordination, planning and execution of CI at conferences

Conducting strategic workshops

Partnering with International Strategic Insights Managers (ISIMs) and US CI to support global and affiliate brand teams on key strategic decision-making

Managing external CI or other relevant vendor relationships and deliverables

Ensuring assigned goals and objectives are met and that assigned projects and other work are completed on time, to high standards and within budget

***THIS POSITION REQUIRES 25% TRAVEL - DOMESTIC/INTERNATIONAL***

 Qualifications:

 At least 3 years in similar roles within industries operating in the pharmaceutical sector or strategic consulting firm for pharmaceutical and healthcare industries

International or global work experience is a plus

Experience with quantitative and qualitative CI techniques and projects

Experience includes past responsibilities for integrating and synthesizing findings from multiple sources to enable informed strategic decision–making and business insights

Experience in Hematology/Oncology

Project management experience in a complex and multiple project environment

Excellent analytical thinking, communication skills, project management

Flexible and adaptable team player

Fluent in English; Other languages are a plus

PLEASE NOTE:

All qualified candidates are encouraged to apply and will be actively considered.  Our talent review and succession planning process has, however, pre-identified potential candidates for this position.

8/20/18 Medical Director or Senior Medical Director - Ophthalmology US Medical Affairs Individual contributor South San Francisco, California

Key Responsibilities for all Medical Directors:

In this role the Medical Directors will be required to perform one or more of the following activities depending on areas of expertise or assignment to specific activities, molecules, or disease/therapeutic areas:

  • Design, execute, and monitor medical strategies, plans and tactics spanning the lifecycle, including but not limited to:
    • clinical data generation design and management
    • sponsored and supported trials
    • registries, exploratory data analysis
    • publications
    • thought leader interactions
    • scientific exchange/engagement and scientific communications/collaborations
    • medical content creation and review
    • medical education
    • scientific congress planning and support
    • evaluate, synthesize, and visualize clinical and economic data and develop written scientific communication
    • identify access-related medical issues and opportunities
  • Monitor adverse events reported and partner with medical monitoring team to identify signal vs. noise
  • Identify clinical strategies to mitigate risk for REMS plan [Risk Evaluation and Mitigation Strategies]
  • Provide clinically meaningful perspective for regulatory and other scientific communications
  • Actively participate and contribute to relevant communities of practice

Key Accountabilities for all Medical Directors: 

  • Maintain an in-depth understanding of relevant medical strategy and clinical, patient/caregiver, payer and healthcare/market landscapes
  • Facilitate Genentech/Roche sharing of information within, across and outside of U.S. Medical Affairs to enable medical progress
  • Depending upon areas of assignment for specific activities or molecules, disease/therapeutic areas or for the full portfolio, acting as a medical individual for relevant study design and monitoring, data interpretation, medical content development and review, scientific exchange and collaboration, clinical training and insights generation to internal stakeholders and external customers.
  • Accountable for implementing strategy through medical tactics, tapping into the network of relevant expertise and insights
  • Contribute medical expertise to Genentech work products and coach/mentor others as needed
  • Act as a guardian for high standards of compliance, ethics and safety; putting patients at the center of all actions

Qualification:

  • MD (Board Certified MD in Ophthalmology and Retina fellowship are preferred)

Required Experience:

  • 3-10 years of pharmaceutical/biotechnology relevant industry experience preferred - preferably in Medical Affairs or product development or is a recognized expert in the field or therapeutic area (with a minimum of 2 years’ clinical experience) 
  • Strong academic/teaching background preferred
  • Understanding of and/or previous experience with Phase I - III and/or Phase IV drug development 
  • Considerable experience in the principles and techniques of data analysis, interpretation and clinical relevance, and medical writing/publication/presentation
  • Proven record in developing strong relationships with constituents in the health care system preferred (therapeutic area clinical experts, professional societies, health systems or payers, etc.)
  • Proven track record of meeting or exceeding objectives and goals; demonstrated self-motivation to design and execute projects at a exemplary level

Skills:

  • Strong customer orientation/focus
  • Ability to flex and thrive in an ambiguous environment undergoing transformational change
  • Works well within teams and is effective in collaborating with others inside and outside organizations
  • Analytical and problem-solving capabilities and skills. Has demonstrated the ability to anticipate and solve problems of moderate complexity and scope e.g. evaluate, interpret and present highly complex data
  • Communication and presentation skills; highly effective at summarizing and presenting key considerations and decision-points
  • Strong business acumen: knows the healthcare industry, key competitors, marketplace factors/dynamics
  • Ability to effectively and efficiently manage multiple priorities
  • Good interpersonal and influencing skills; can effectively and quickly establish rapport with all key internal/external partners and stakeholders and influence without authority
  • Good negotiation skills: can drive discussions and decisions towards desired results
  • Understanding of legal and regulatory considerations impacting pharma/biotech industry and ability and judgment to apply principles to daily activities
  • Strong attention-to-detail
  • US and International business travel, by air or car, is required for internal and external business meetings, generally once a month but on occasion, a few times a month.
8/20/18 Cross-Portfolio Lead, Senior Manager Individual contributor South San Francisco, California

               

The Pipeline & Portfolio Planning (PPP) group, within Portfolio & Product Development Strategy (PPS), drives proactive portfolio management, product development strategy, and lifecycle planning. As a trusted partner to teams and decision makers, PPP delivers robust portfolio strategies, guides investment decisions, provides portfolio insights and analytics, and supports decision making to maximize Roche late stage portfolio value for the benefit of patients and Roche.

The Cross-Portfolio Lead leads or supports various strategic planning and portfolio reporting processes and/or initiatives and/or tools across late stage and the REDs, supporting both colleagues in PPP and project teams, as well as governance and partners in GPS, Finance, Partnering etc.    The Cross-Portfolio will focus primarily focus on Portfolio Knowledge and Systems, which are critical to enabling portfolio insights and valuation as well as portfolio strategy.  This role have close collaboration across the entire PPP team and think about the needs of  key external stakeholders (includingdecision-makers, project teams and functional heads /resource managers). 

Major Responsibilities and Accountabilities: (as appropriate)

  • Lead/support development of portfolio systems and represent the voice of PPP in corporate IT systems and related change processes.  Participate on teams in close collaboration with project management, informatics, finance and PD functions.  Role will also own development of training materials, handbooks, and related change management communications.  
  • Lead/support PPP in cross-functional initiatives, including portfolio reviews and portfolio strategy development.  Support the Late Stage portfolio committee in developing / refreshing TA strategies, and assessing portfolio level options for sustainable value generation. 
  • Maintain knowledge of company products, competition, and broader market dynamics that frame the business context both present and over the next few years, and act as a thought partner in strategic discussions outside of own projects
  • Lead/support regular reports on the status/progress of portfolio, incl. the REDs.
  • Lead/support cross PPP/PPS/PD projects and deliverables as appropriate.
  • People/team/system/project management as appropriate.

Qualification, Experience and Expertise:

  • Ability to identify, scope and manage systems-related projects, maintain responsibility for deliverables and timelines, adapt to shifting priorities, and manage stakeholder relationships and expectations.
  • Prior experience on teams responsible for building and managing portfolio systems required.  Direct experience with agile team methods a plus. 
  • Strong communication and presentation skills.
  • Strong communicator; ability to build cross-functional partnerships and influence without authority.
  • Understanding of relevant portfolio management tools, systems and software.
  • Advanced degree in science, business, engineering or computer science; MBA or PhD a plus.
  • Experience in management consulting, strategic planning or IT ystems design/management are a plus. Strong financial acumen also a plus.  Experience with data visualization (Tableua, Spotfire, Domo) tools is a plus.
  • Knowledge of drug development, R&D trends, strategy and markets; preferably through at least 5 years’ work experience in biotech, pharmaceuticals or a related field.
8/20/18 Scientific Researcher, Biochemical and Cellular Pharmacology Department, Genentech Research Individual contributor South San Francisco, California

We have an opening for an enthusiastic and talented Scientific Researcher to join our Biochemical and Cellular Pharmacology Department. The successful candidate will primarily be responsible for developing, validating and executing innovative biochemical and cellular assays to support small molecule drug development projects for Immunology and Cancer Immunology indications in our South San Francisco location.

Strong education in cellular and molecular biology is highly desirable. The ideal candidate would have experience working with human primary cells and physiologically relevant models. Familiarity with automated or semi-automated instrumentation is preferable. Experience with both qualitative and quantitative data analysis methods and software is required. The position requires good organizational skills, the ability to work well as part of a team and excellent communication skills.

The qualified individual will possess at a minimum a B.S degree, M.S. is preferred, and at least 3 years of relevant experience on small molecule drug discovery projects in the pharmaceutical or biotechnology industry. Familiarity with rigorous data analysis methods and software, including automated dose-response measurements, is preferred. The position requires application of rigorous quantitative biochemical and cell assay approaches, the ability to present scientific data intra- and inter-departmentally and the ability to work well as part of a team.

#LI-gRED-MK1

8/20/18 Regional General Manager - Oregon, Idaho, Montana Individual contributor Oregon, Oregon

Regional General Manager - Oregon, Idaho, Montana

Regional General Manager must reside within the Portland, Oregon area.

The RGM is responsible for managing a diverse set of targeted and complex regional customers including:  managed care organizations (Health Plans), Medicare Administrative Carriers (MACs), state Medicaid agencies and large integrated hospital delivery networks (IDNs). 

RGMs are held accountable for delivering against key business metrics including: ACCESS, REVENUE, VALUE and LEADERSHIP; while modeling Account Management Excellence (AME). They are expected to develop a deep marketplace understanding and serving as the regional healthcare market expert ensuring that both Genentech and their key GNE field partners are positioned for optimal short, medium and long-term success.  They are expected to accomplish this by leveraging in-depth market and cross-segment knowledge to understand the interplay among disparate customers and segments in order to strengthen the position and/or representation of Genentech products to improve patient access, and support Genentech brands in achieving financial results.

RGMs are also called upon to serve as Key Account Lead (KAL) in select IDN accounts which also have various Genentech cross-functional Business Unit account management partners assigned.  In this role, they are responsible for developing a “ONE GENENTECH” Account plan annually with their BU account manager counterparts to ensure they are customer centric in their engagement and effectively prioritizing in order to maximize overall business results, thereby aligning with Genentech’s Operating Principles of being: “Genentech’s Ambassador”, “Owning our Business”, “Partnering with a Purpose” and “Empowering for Action”. 

They are also expected to represent their assigned markets and customers to ensure both are consistently and appropriately incorporated into cross-functional strategies, plans and objectives. Additionally, they are responsible for developing and maintaining key contacts and strategic relationships, facilitating business-to-business relationships, negotiating and managing contracts and facilitating pull-through at the local market level.

They are expected and responsible for providing fair, accurate and complete information and compliantly representing Genentech's products and services while complying with all laws, regulations, policies and procedures that govern our business. 

Key Responsibilities

  • Representing Genentech’s products to the highest ethical and professional standards and in accordance with guidelines, strategic direction and key brand marketing direction while using only approved resources and messaging
  • Ensuring targets, goals and objectives for the assigned accounts are met or exceeded, including favorable negotiation outcomes that align with approved strategies
  • Modeling Account Management Excellence (AME) principles and practices; performing in accordance with AME standards
  • Creating and maintaining product ACCESS to our FDA approved indications in assigned accounts
  • Developing and implementing strategic and tactical business plans across multiple account segments and in full alignment with brand and corporate Genentech objectives
  • Developing relationships and influence across multiple account segments for immediate- and sustainable financial and business results.  Includes ensuring favorable negotiation outcomes that align with approved Managed Care & Customer Operations (MCCO) strategies
  • Conducting quarterly business reviews with assigned account to ensure terms are adhered to and to identify additional collaborative opportunities
  • Serving as a local health care market expert for Genentech field teams regarding the general regional marketplace and within all targeted accounts
  • Serving as a Key Account Lead (KAL) in select IDN accounts to ensure effective planning, prioritization and collaboration across cross-functional BU account management partners
  • Working closely with your manager, peers, and other partners to review historical business analysis and market-related research to assess, synthesize, identify and recommend strategic opportunities to maximize business results
  • Responsible for identifying and recommending resources necessary to meet or exceed account plans, goals and objectives

The successful candidate will demonstrate the following competencies critical to this role:

  • Strategic agility – Links responsibilities with the mission of the organization; focuses on activities that add the most value
  • Achieving results – Is goal-directed and persistent; is accountable for meeting commitments’ recognizes the contributions of peers
  • Teamwork and collaboration – Creates an atmosphere of openness and trust; collaborates; offers support and encouragement
  • Technical and business expertise – Applies emerging knowledge and trends; builds strong relationships; contributes to expertise within and beyond assigned area

Qualifications

  • Bachelors Degree
  • MBA or other related graduate-level degree is preferred
  • Average of 10 or more years’ work experience
  • 4 or more years’ previous managed care account management experience, preferably gained within the biopharmaceutical industry segment.  Experience working simultaneously with customers across multiple account segments.
  • Previous experience working within Health Plans or Integrated Delivery Networks (IDNs) is strongly preferred
  • Must demonstrate in-depth knowledge of managed care strategy development, including contracting strategy, administration and pull through
  • Must demonstrate current, strong relationships with multiple customers in regional accounts
  • Previous field sales management and/or marketing experience in the biotechnology, pharmaceutical, or related industry is preferred
  • Proven track record for consistently meeting or exceeding financial and/or other quantitative targets, as well as qualitative goals
  • Previous experience in developing and implementing attainable business plans for accounts across each account segment (private payers, public payers and hospital systems)
  • Previous experience in successful project management and special projects/assignments that have resulted in improvements in areas beyond those of his/her immediate scope and responsibilities is desired
  • Proven track record in coaching, training and/or mentoring peers or others as assigned; helping such others to better meet or exceed their goals, targets and other responsibilities

This position requires significant use of either a company provided or personal vehicle to perform the essential duties and responsibilities of the role.  As a result, Genentech, Inc. (Company) from time to time will check your motor vehicle record for purposes of determining your eligibility for driving a Company vehicle or driving any vehicle on Company business.

This is a remote position

8/18/18 Project Manager - IT, Research & Early Development Individual contributor South San Francisco, California

Project Manager -IT, Research & Early Development

The Position:

The primary mission of the Genentech Research & Early Development (gRED) organization is to discover and rigorously assess promising molecule candidates for viable therapeutic benefits.  

As the gRED IT Project Manager, your primary responsibilities include the planning, execution and monitoring of IT projects that are needed to ensure that gRED can deliver on key business objectives. You are required to lead cross-functional IT teams in delivery of project goals while managing project scope, time and costs.

You are a great team player who works well with other IT professionals and business stakeholders towards the common vision of delivering on solutions to enable the company in providing novel therapeutics to our patients.?

Responsibilities:

  • Provides project management and business analysis for various applications

  • Can concurrently manage 1 – 3 projects of diverse scope across functional areas. Primary responsibility will be to support the Knowledge Management functional area which includes document management and collaboration platforms.

  • Manages projects using the corporate IT Project Management Methodology (PMM) lifecycle

  • Creates and/or assists with required project documentation practices such as user requirements, functional specifications and testing plans

  • Directs developers and SQA resources in the creation and testing of applications to support business requirements

  • Manages project statements of work (SOW), change requests, requests for proposal and other procurement activities in conjunction with IT planning teams as required

  • Effectively communicates to stakeholders in verbal and written form and represents both gRED and IT to interfacing departments and external affiliates

  • Manages project budgets, scheduling, planning and contractor resource assignment and track vendor and consultant performance including billing against budget and contract

  • Collaborates effectively with business, technical and validation resources, to ensure project delivery and on-going support of business services and applications

Minimum Qualifications:

  • BS or BA degree in information systems or engineering discipline

  • 5-7 years of project management experience

  • A strong understanding in the application of information systems management and modern technology platforms and trends. Experience in managing projects across multiple technologies and platforms

  • Experience in multiple delivery techniques: SDLC, Agile

  • A professional focus on solution delivery and strong customer-service

  • Preferred: Previous experience working in life sciences or drug development

  • Preferred: Previous experience with SharePoint

8/17/18 Principal Quality & Compliance Manager Manager without direct reports South San Francisco, California

Position Summary:

This position serves as the primary Quality and Compliance Office (QCO) single point of contact for GCP/GVP compliance support for Genentech Early Development (ED) therapeutic area and clinical study teams. The key activity of the role is providing expertise and guidance regarding regulatory requirements, GCP guidelines and Roche Standard Operating Procedures (SOPs) for the conduct of clinical studies.

As an expert, the Clinical Quality Compliance Lead (CQCL) will utilize a risk-based strategy to prioritize QCO support for clinical trial activities, identify and escalate compliance issues, enable pro-active decision-making, and support the development and execution of effective and comprehensive action plans to address quality and compliance risks. In addition the

CQCL will partner with Quality, Regulatory, Safety and other key functions to enable transparency and escalation of quality and compliance matters.

This position serves as an important conduit to the broader organization to ensure a culture of quality and compliance. Incumbent will leverage his/her compliance expertise coupled with a comprehensive understanding of the R&D landscape to proactively contribute to the Genentech Early Development organization. Incumbent will communicate and interface with a host of internal cross-functional partners, both within Genentech and other Roche functions; identifying areas for improvement and ensuring compliance with current regulatory policy, legislation and guidance. The CQCL will actively contribute to the development and implementation of Policy/Standard Operating Process / Procedures in addition to tools, and templates deemed controlled in supporting regulatory requirements for application in drug development and clinical trial execution within the Genentech Early Development organization.

The CQCL is expected to foster an open and collaborative environment across the global site network and will ensure implementation of Global Quality (GCP/GVP/ICH), Legal and Healthcare Compliance strategies within assigned functions.

Key Responsibilities:

• Provide quality leadership and direction to Genentech ED stakeholders on GCP related activities/issues and act as GCP expert/consultant for QCO colleagues.

• Act as QCO member of clinical study teams for relevant Therapeutic Areas.

• Develop strong relationships with ED personnel across functions and teams providing coaching and compliance guidance as needed.

• Collaborate with stakeholders in conducting ongoing risk assessment of clinical trial activity in order to identify: priority studies, compliance metrics for tracking, high-risk vendors, and key QCO activities (i.e. protocol review, vendor evaluations, inspection readiness).

• Identify and escalate significant compliance issues to QCO and relevant leadership, including the assessment of serious breaches.

• Participate as member of Contract Research Organization (CRO)/Vendor governance teams for assigned Therapeutic Areas/Studies.

• Establish relationship with CRO Quality Team member for the ongoing review of quality and compliance issues.

• Participate in vendor evaluations as a Subject Matter Expert (SME) as needed.

• Support ED clinical teams/functions in drafting responses and CAPAs to internal and external audit findings.

• Provide support and guidance for ED Quality Management System activities including selfreporting

deviations, root cause analysis and Corrective Action/Preventative Action plan development and evaluation.

• Present GCP training to ED functions based on identified needs.

• Facilitate the presentation and interpretation of audit and inspection metrics.

• Identify and anticipate trends in quality issues and collaborate with department management to ensure risk-managed solutions are implemented in a timely fashion.

• Maintain high level of expertise in international GCP regulations and internal Policies and Procedure that may impact drug development.

• Promote cross-functional communications and alignment with other GCP/GVP and Healthcare Compliance partners within the organization.

• Provide regular updates to senior management functions and participate in the resolution of quality issues.

• Liaise with respective training functions to assess job role training requirements and participate in the development and execution of GCP, SOP or Policy related training (as required).

• Provide support and guidance during and following internal audits and external regulatory inspections (as required).

• Support investigations and corrective action plans for appropriate discrepancies as it relates to ED and /or direct the internal investigation of compliance issues as required, collaborating with relevant Compliance Partner(s).

• Provide expertise and consultative guidance on business initiatives involving systems, processes, procedures, regulations and tools intended for use in clinical trial conduct and/or regulated drug development activities.

• Supports ED Inspection Readiness program and make recommendations for its continuous improvement.

• Serve as an advisor to management, as needed, and act as an internal/external spokesperson for the organization on matters pertaining to policies, quality plans, objectives and business goals.

• Work collaboratively with all internal and external business partners and key stakeholders to assess clinical business systems and processes and provide input on any unique business requirements.

• Lead or participate on quality and compliance initiatives, as assigned.

Who You Are

Qualifications:

• Bachelor’s degree in scientific, health sciences or quality related field.

• Minimum of 12-15 years with in a pharmaceutical drug development GCP related discipline.

• Expert knowledge of international GCP drug development regulations, including USA

(FDA), EU (EMA, MHRA) and ICH Guidelines.

• Previous experience managing quality and GCP compliance issues.

• Experience with cross-functional stakeholder management.

Skills:

• Expert knowledge of the drug development processes.

• Demonstrated strength in analytical and strategic assessment of regulatory compliance risks and the ability to articulate potential business impact.

• Must be flexible and comfortable with a risk-based approach to quality and ownership of quality across functional lines.

• Ability to influence people at different levels and negotiate cross functionally in matrix organization to resolve conflicts.

• Ability to build and sustain meaningful relationships with business stakeholders and partners.

• Pro-active, solution oriented mindset and sound judgement for evaluation of risks, guidance and escalations

• Strong project management skills including team leadership, consultative facilitation, risk analysis, and project planning.

• Highly self-motivated, well organized, confident, possessing a solution oriented mindset and able to develop innovative solutions to issues.

• Strong computer literacy in MS Word, Excel, Project, Visio and PowerPoint.

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8/17/18 PHC, Data Science Imaging Individual contributor South San Francisco, California

The PHC Data Science Imaging group seeks a talented and motivated Imaging Data Scientist to join us in supporting the efforts of the Personalized Healthcare (PHC) Group. To aid in the development of novel imaging biomarkers in PHC and their potential use in clinical drug development, the RWD Imaging Group at Roche is responsible for generating and executing plans to: (1) curate and analyze clinical imaging data from Roche’s late stage (Ph3) clinical trials, and (2) devise plans to gain access to (and analyze) clinical imaging data from a RWD setting (e.g., health registries, hospital systems, etc.).

The position requires extensive cross functional collaborations working with a diverse team of clinical subject matter experts, data- and imaging scientists, statisticians, and IT staff.  Your responsibilities will primarily support image analysis efforts within the group, focusing especially on applying Machine- and Deep Learning approaches to oncology-, neuroscience-, and ophthalmology projects. In addition to developing and applying novel, data-driven approaches to solving RWD image analysis challenges, the position requires the Imaging Data Scientist to work closely with clinical imaging data management group to deploy, maintain and integrate computational solutions. The job will utilize and build on your experience in scientific/medical imaging, data and image management, application of novel statistical and machine learning approaches to `big data’, software development, and scientific data transfers.

Responsibilities:

  • Collaborate with internal imaging- and data scientists and external vendors to derive and validate novel imaging biomarkers in support of clinical drug development and RWD evidence (payer support) generation

  • Identify and gain access to external RWD imaging data sources

  • Curate/clean/organize large and messy clinical imaging datasets

  • Identify and support imaging data management solutions within PHC

  • Continually search for opportunities to automate workflows and streamline processes

  • Support and contribute to the development of advanced analytics and computational tools  

Required skills:

  • Proficient in at least two scripting languages such as Python, Matlab, R, Perl, etc.

  • PhD or MS in quantitative field (eg mathematics, statistics, computer science, EE, etc.), and/or adv. Life Sciences degree with significant computational experience

  • Documented experience with Machine Learning, Deep Learning, and statistics

  • Solid understanding of medical image formats (ie DICOM)

  • Experience with database applications

  • Excellent communication skills

  • Ability to multitask and prioritize while maintaining efficiency and quality of work

  • Internally motivated with a commitment to accuracy and quality

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8/16/18 Government Affairs Senior Manager - San Francisco or Washington, D.C. Individual contributor South San Francisco, California


Government Affairs Senior Manager  - This position will be based in either Genentech’s South San Francisco headquarters or the Washington, D.C. Government Affairs office.

The Alliance and Advocacy Relations team (AAR) within Genentech’s Government Affairs Department is seeking a qualified Senior Manager candidate.  The AAR team is responsible for leading the strategy and outreach related to Genentech’s business interests with external health care-focused advocacy organizations.  He or she will lead development, implementation and oversight of advocate engagement strategies, plans and programs for the lung, kidney, colorectal, brain and prostate products and other pipeline areas as needed.  She/he will represent Genentech to external advocates, establish and maintain in-depth awareness of the disease areas current and future business plans with among advocates current and future interests, and the relevant surrounding policy and legislative environment.  She/he may also play a leadership role in departmental projects, train, coach, mentor, and oversee some of the work of other AAR team members.  She/he will work as a member of the Genentech Oncology AAR team and will report directly to the head of AAR for Oncology.

Key Accountabilities

  • Maintain strong understanding of the oncology patient advocacy communities
  • Create strategies for effective engagement and communication on public policy, reimbursement, disease education and patient assistance programs
  • Develop and implement plans for relationship building, communication and collaboration with non-profit organizations
  • Maintain thorough scientific knowledge of Genentech oncology molecules
  • Cultivate critical and influential relationships with cross-functional business partners
  • Collaborate with patient organizations and internal team to identify and evaluate grants that support Genentech’s goals in the disease area and cross-portfolio
  • Represent Genentech at medical and patient meetings, conducting one on one meetings and larger briefings
  • Collaborate with USMA, PD, pRED and gRED on strategies to engage advocates and collaborate on patient-centric medical practices.
  • Represent Genentech's and Roche's focus areas to the highest ethical and professional standards and in accordance with guidelines, strategic and key business direction
  • Attend outside meetings or events, as appropriate, to stay abreast of national, local and/or regional changes, trends of advocate organizations

Core Competencies

  • Communication
  • Teamwork and collaboration
  • Technical and business expertise
  • Strategic agility

Qualifications

  • A BA or BS is required
  • Must be a leader who is willing and able to take responsibility and ownership for following and analyzing patient access issues and trends.
  • Strategic agility:  Qualified candidates must be highly motivated to take the initiative to further explore areas important to both Government Affairs and Genentech while working collaboratively with other team members in a dynamic and fast-paced environment.
  • Relationship management:  Candidates must have experience working with non-profit organizations, or other relationship-management expertise and project management skills built from similar experience over many years.
  • Communication:  Exceptional communication skills and ability to influence without authority, including demonstrated experience gaining senior leader perspectives and support.  Outstanding ability to build relationships and collaborate with diverse audiences with array of viewpoints.  Outstanding influencing and negotiation skills: demonstrable through considerable past achievements.
  • Speaking/Presentations: Highly level of comfort and ability to present information to large group of internal colleagues and external audiences including customers.  Strong communication skills, both written and verbal; including very good listening skills and an open attitude and acceptance to being coached
  • Project Management:  Strong planning and organization skills with the ability to set priorities effectively and efficiently, identify areas that need further research, and multi-task on a number of issues while notifying team members and supervisor of work progress in a timely and appropriate fashion.  Ability to effectively delegate project work to internal staff, consultants and agency partners. 
  • Collaboration:  Strong collaborative skills and ability to develop and maintain working relationships across multiple internal teams and external stakeholders.
  • Travel:  Willingness to travel 60% or more of their time
  • Proven track record for consistently meeting or exceeding expectations, goals, objectives, etc. in past positions

**** Location can be Washington, D.C or South San Francisco Office

8/16/18 Senior CMC Project Manager, Regulatory Project Management Office (PMO) - TEMPORARY Oceanside, California

This role is for temporary employment for a duration up to 12 months.

The Product Project Manager Position is dedicated to supporting Technical Regulatory Teams (TRTs) in managing programs efficiently and effectively and in executing regulatory activities. This role will be involved in all aspects of TRT operations, while maintaining a tight linkage to the PTR Product Portfolio Management Office (PMO). The Product Project Manager is an advocate of the PMO, utilizing best practice methodologies to support TRTs and providing clear communications to the PMO for assessment and trending at the portfolio level.

This role builds effective relationships with Technical Regulatory Leads (TRLs), TRT Members, Product PMO, Technical Development Teams, Technical Product Teams, and other program stakeholder to ensure visibility to TRT operations and cross-functional alignment of TRT strategy. The technical manager may act as a single point of contact for a TRT, second only to the TRLs, the primary accountable leaders of TRTs.

  • Support TRTs and TRLs in developing TRT charters, plans, detailed schedules, deliverables lists, status updates, resource requests and program specific communications for individual programs in the regulatory product portfolio including large molecules, small molecules, devices, antibody drug conjugates.
  • Provide technical management support to TRTs at any stage of the drug development lifecycle (i.e. clinical /development, marketing authorization or post-launch marketed phases).
  • Coordinate and facilitate TRT meetings and all aspects of program information management ensuring robust documentation and communications.
  • Partner with TRLs and site management, facilitating team interactions and mobilizing teams to deliver successfully on the agreed objectives.
  • Execute project management activities to support products for global market applications and product life-cycle activities.
  • Support issue-specific multi-product impacting regulatory projects to ensure alignment of regulatory strategy and compliance across the Biologics and Small Molecule platform.
  • Ensure regular and meaningful project communications, including dashboards, reports and metrics, to enable timely information and analyses to key stakeholders and decision makers.
  • Ensure product information flows between TRT members to ensure transparency, informed decision making, and optimal alignment of all technical regulatory deliverables.
  • Maintain linkage between TRT and TDT or TPT ensuring alignment of assumptions and communications at all times.
  • Facilitate regulatory program risk assessment and align with TPM and TDT processes. Develop, execute and report on risk mitigation or issue resolution activities.
  • Monitor critical path timelines and resources for assigned products using appropriate tools, principles and practices to deliver successfully on time. Collaborate with Program Managers from cross-functional teams as necessary (TDT, TPT, RAFT etc.).
  • Provide support to the Product PMO and to the PTR site management on major departmental and cross functional initiatives.
  • Leverage and continuously improve Product PMO business process and program management methodologies.
  • Develop and maintain the PMO resource library (templates, tools etc.) and improve it based on use and feedback by the TRTs.
  • Collaborate with Regulatory Operations and colleagues in PTR and PDR for regulatory submissions as needed.
  • Train junior PTR colleagues in the principles of Project Management and establish simple project management processes for early stage products.

Education & Experience

  • BA/BS in Scientific, Technical, Engineering or Business discipline.
  • A minimum of 5 years’ total work experience with at least 2 or more years’ relevant experience in project management within the pharmaceutical/biotech industry with a sound knowledge of drug development processes.
  • Project, Program, or Portfolio Management certification is preferred; Knowledge of Portfolio and Program Management methodologies, concepts, techniques and tools is required.
  • Prior experience managing portfolios in a strategic context is a plus.
  • PMP Certification preferred.
  • Prior regulatory experience a plus.
  • Six Sigma or other OE-related certifications a plus.

Knowledge/Skills/Competencies

  • Demonstrates, or has proven abilities to demonstrate PTR and Roche Core Competencies.
  • Proven abilities to effectively lead, organize and prioritize the work of others.
  • Strong influencing skills; consistently achieves targeted results without authority and by leveraging his/her expertise, business knowledge, interpersonal skills, organizational savvy and relationships.
  • Strong partnering skills; has exceptionally strong and highly effective working relationships with internal and/or external customers, partners and stakeholders.
  • Excellent interpersonal and organizational skills, including understanding of key change management concepts and methodologies.
  • Must work well as member of a diverse team and in a proactive, positive and collaborative manner; Ability to lead cross-functional teams.
  • Outstanding project management, planning, organization and time management skills. Can effectively and efficiently manage and complete multiple, large-scale and complex priorities and projects on-time and on-target.
  • Demonstrates Roche Values and Core Competencies.
  • Able to deal with ambiguity and constant change.
  • Able to work independently with minimal supervision.
  • Able to function effectively in a fast-paced, multi-tasking environment.
  • Knowledge of regulatory requirements, manufacturing or technical development processes, cGMPs or compliance experience a plus.
  • International or global business experience and cultural awareness preferred.
  • Highly Competent in MS office applications including Excel, PowerPoint, Word, Project, etc.

TRAVEL REQUIREMENTS

  • Ability to travel up to 20%

8/16/18 Principal Project Manager, Strategy and Risk Management Team Leader Oceanside, California

The Strategy, Communication, and Risk Management Principal position is aligned across the PT Manufacturing network per Blueprint implementation.  This position will report directly to Head of Business Support at the site and plays a key role in ensuring development and deployment of site strategy and goal cascade.  This role is responsible for developing, analyzing, and leveraging key metrics to improve overall site business performance. This role develops and oversees site-wide communication strategy and its execution.  This role also owns site risk management and business continuity management programs. 

Business Planning and Site Strategy Deployment

  • Develop site strategy, develop goals, execute operational reviews, drive annual business process
  • Lead the development of Site Business Plan
  • Lead and maintain site strategy realization
  • Coordinate the development, implementation and monitoring of Site Goals and KPIs
  • Ensure strategic alignment between the site and the Roche/Genentech network
  • On-board new goal leads and clarify roles and responsibilities, assist with charter creation and review of expectations
  • On-board new KPI Stewards and clarify roles and responsibilities, assist with KPI calculations and coordinate updates
  • Manage monthly and quarterly operational reviews and site metrics reporting
  • Manage metrics and performance collection and reporting to site and network

 

Communication Strategy and Execution

  • Develop and oversee site-wide communication and its execution-
  • Oversee full ranges of communication media, tools and applications on site
  • Provide effective communication tools for site goal and KPI status

 

Risk Management (RM) and Business Continuity Management (BCM)

  • Provide oversight and ownership for the Risk Management and BCM process at the site
  • Manages business risk portfolio and interface with MU KAM to ensure alignment between the site and the network.
  • Acts as the single point of contact (SPOC) for site RM and BCM program
  • On-board new members to the site RM and BCM teams
  • Advise site leaders on RM and BCM topics
  • Apply RM and BCM principles to site business process and operations
  • Promote best practice sharing and adoption aimed at continuously improving the network standard processes
  • Apply strong networking skills and focus on cross functional collaboration

 

Education and Experience

  • 10 or more years of experience in healthcare/ biotech/ pharmaceutical industry
  • 5 or more years in project or people management
  • BS or BA in Scientific, Technical, Engineering or Business discipline
  • MBA or other related graduate degree is highly preferred

Knowledge, Skills and Abilities

  • Strong verbal and written communication skills and ability to influence at all levels
  • Familiar with manufacturing and business processes at a biotech site
  • General understanding of the opportunities and challenges within a biotech network
  • Able to think strategically and translate strategies into actionable plans
  • A self-starter with demonstrated ability to anticipate/identify business challenges and implement effective solutions
  • Take responsibility and drive for results
  • Embody Roche PT Lean Leadership Principles and methods
  • Actively contribute to site business operation leadership team on broad business scopes
  • Highly Competent in MS office applications including Excel, PowerPoint, Word, Project, etc.

This position is not eligible for relocation. 

8/16/18 Principal Talent Partner, Pharma Technical Operations (PT) Individual contributor Vacaville, California

RESPONSIBILITIES

As a Principal Talent Partner, you will partner with senior management in the recruitment of talent to Genentech - individually managing a portfolio of openings and focusing on meeting or exceeding client's expectations and ensuring a positive candidate experience. In this position, you will be the primary Talent Partner/Advisor for Genentech’s state of the art Drug Substance manufacturing facility in Vacaville, CA.  You will work with employees and managers in the client organization to assure that we have the talent required to meet their business objectives – supporting Manufacturing, Quality, Engineering, Materials Management, Facilities Engineering, and other operations focused positions. As a leader within the group, you will foster a team environment and demonstrate collaborative leadership. You will partner with the Human Resource Managers and Talent Acquisition Management to develop and implement staffing plans and strategies for your client groups while ensuring that elements of diversity and organizational fit are included in the recruiting and hiring process.   

Additional responsibilities may include

  • Managing expectations of hiring managers and candidates, identifying and resolving issues
  • Drive the employment process and strategies within assigned organization, including developing complex recruiting strategies
  • Coach managers in providing feedback to candidates, developing offers, determining competencies, coordinating and training interview team
  • Perform executive recruiting, including identifying appropriate Contingency or Retained Search firms, maintaining relationships and partnering to ensure that candidates are interviewed expeditiously
  • Conduct interviews using in depth behavioral and skills assessment techniques
  • Attend job fairs, conferences and networking events
  • Contribute to the development of staffing process improvements.
  • Ensures recruiting solutions are consistent with Corporate Talent Acquisition objectives
  • Act as point person for clients in providing staffing reports and metrics
  • Act as project manager for client focused staffing projects (not just req focused)
  • Utilize, update and maintain applicant tracking system and CRM
  • Educate managers on legal implications in hiring
  • Develop advertising strategies for specific groups and coordinate advertising activities with recruitment advertising agency
  • Thorough understanding of relocation/Immigration process and resources
  • Thorough understanding and adherence and enforcement of internal staffing process
  • Partner with finance in determining headcount
  • Manage the reconciliation of the budgeted headcount vs. actual headcount
  • Negotiation skills
  • Demonstrate use of internal tools and resources
  • Demonstrate understanding business issues and impact to staffing
  • Presentation skills
  • Work with Talent Acquisition Manager on budget recommendations
  • Manage and oversee relocation/recruiting budget for individual client group at the officer level
  • Pipeline management, promotion and reporting
  • Partner with Client Group on internal talent management, including succession planning, talent review and internal candidate movement
  • Proactively manage escalation process related to all requisition activity (internal vs. external challenges)
  • Responsibility for Conference/Event management related to external recruiting, partner with Corp Talent Acquisition in strategic direction of event, and determine ROI for event participation

REQUIREMENTS

  • 8+ years of recruiting experience and Bachelors degree required.
  • Recruiting in a corporate environment is required and biotech or pharmaceutical recruiting experience is desirable.
  • Thorough knowledge of corporate business operations and the ability to translate business needs into recruitment strategies and actions
  • Strong technical expertise in where to source appropriate candidates for client groups
  • Substantial internal and external business knowledge
  • Thorough understanding of compensation guidelines and structures for a variety of roles
  • Ability to track and implement metrics to track recruitment success
  • Demonstrated expertise In utilizing progressive sourcing options such as direct sourcing, web 2.0 recruitment tools, networking, college recruitment, diversity recruiting, employee referrals
  • Strong assessment skills to evaluate candidates business and or technical background
  • Knowledge of behavioral interviewing techniques.
  • Experience supporting clients in operations (manufacturing, quality, engineering, supply chain, facilities) preferred
  • Additionally, the position requires excellent customer service skills and a consultative approach when dealing with internal and external clients and strong communication and relationship management skills.
  • Demonstrated ability to coach, manage and develop staff preferred.
  • Strong teamwork and collaboration skills are required as well as taking on additional responsibilities as needed.
8/16/18 Portfolio Manager - GIS Individual contributor South San Francisco, California

The GIS Portfolio Management Office helps prioritize, resource and enable a diverse variety of change activities to ensure we select the right activities and execute those activities well.  We provide adaptive and flexible portfolio management services to help deliver business outcomes consistently amid frequent change.

Responsibilities:

  • Contribute to the strategic vision, and then enable excellent delivery and quality assurance for activities such as projects and programs within the portfolio

  • Provide need investment advice that understands our business and technology context and priorities.

  • Create an integrated view to help others see how their work impacts or is impacted by others.

  • Report progress of the portfolio to senior management with specific emphasis on business objectives delivery, efficient resource deployment, effective risk and issue management, portfolio volatility with respect to scope and quality changes, and process improvements

  • Create project business cases, identifying the business impact, the probability of satisfying business needs, the anticipated business benefits, and the risks and consequences of failure

  • Create lean processes and templates to enable efficient project and portfolio delivery

  • Act with constant curiosity about processes, activities and strategy and ask good questions.

  • Flexibly shift between Executing, Coaching, Consulting, and Brokering postures depending on the context and partner need.

  • Measure, review, and audit projects and program management to ensure conformance to Group IT standards.

  • Identify and plan systematic corrective action to reduce errors and improve the quality of the projects through root cause examination

  • Consistently measure the benefits of our investments.

  • Direct and lead significant improvement programs while ensuring new methods and tools are adopted by users

  • Take part in professional activities and development outside the organization to bring out outside view in.

Skills and Qualifications:

  • Bachelor’s degree required

  • Master’s degree preferred but not required

  • PMP/PMI certification for Portfolio Managers preferred but not required

  • Exhibits strategic management skills at the highest levels and in a wide variety of contexts

  • Builds and sustains effective relationships at all levels, particularly with partners

  • Excellent interpersonal, planning, communication, and presentation skills

  • Able to understand, explain, and present complex technical ideas to both technical and non-technical audiences at all levels in a persuasive and convincing manner

  • Able to analyze and explain the risks involved in using, or not using, solutions to business or organizational problems

  • Hands-on experience in project/portfolio resource planning, reporting, prioritization, and budgeting

  • Has proven project management and leadership skills and a good knowledge of business analysis

  • Has achieved proficiency in the roles of project manager, senior project manager, and program manager (preferred but not required)

  • Demonstrated success creating clear insights from portfolio data using Excel, Business Objects and other tools

  • Strong process and detail orientation

  • Demonstrated ability to manage conflicting interests within a complex environment

  • Demonstrated ability to work within a virtual or geographically distributed team of project managers and portfolio analysts

  • Demonstrated influencing skills in a global environment

8/16/18 Principal/Sr. Project Manager - Pharma Informatics (IT) - Development Sciences Individual contributor South San Francisco, California

Principal/Sr. Project Manager – Pharma Informatics (IT) - Development Sciences

The Position

Genentech Research & Early Development (gRED) organization’s mission is to discover and rigorously assess promising molecule candidates for viable therapeutic benefits.

The Sr. IT Project Manager will be responsible for providing right-sized project management in support of delivery of programs and projects for the Development Science Group within gRED. The Sr. Project Manager will lead cross-functional project team(s) in partnership with the Business Lead(s), vendors and other cross-functional IT partners to achieve project goals while managing project scope, timeline and costs. This candidate will be proactive and detail-oriented with strong leadership skills, excellent problem solving and written/verbal communication skills. The Sr. Project Manager is expected to deliver outstanding customer service, provide technical and application support knowledge and ensure timely and effective communications to all levels of stakeholders including business sponsorship.

In addition to strong PM skills, the right candidate will support program/portfolio management responsibilities as required.  As a Program Manager, this position will work with the business teams and the broader IT organization, to participate in strategic discussions and and any discussions related to the technology roadmap upon request.

Major Responsibilities include:

  • Project Stakeholder / Communication Management - Create collaborative partnerships, with customers, vendors and other gRED teams to achieve project objectives. Ensure project objectives/requirements are clear and agreed to by all stakeholders.

  • Project Delivery - Plan, baseline, and control costs to ensure projects are delivered on time, within approved budget and with the expected benefits defined at project entry.

  • Project Risk, Assumption, Issue and Dependency (RAID) Management - Assess potential impacts with the project team. Formulate risk mitigation strategies, recommend solutions, actively managing and integrating with any dependent projects or activities.

  • Project Planning, Tracking, Control & Reporting - Track progress against baseline schedule through controlled and documented change management. Provide accurate and timely project status reports.  Escalate to sponsors, stakeholders, functional managers, and/or senior management, as appropriate to keep projects on track, in scope, and on budget.

  • Team Building & Leadership - Organize and supervise the appropriate involvement of project resources and actively managing and addressing the resolution of conflicts within the project team.  

  • Compliance – Directly accountable for ensuring compliance with project management, portfolio management and CSV policies, guidelines, process tools and reporting standards of the portfolio.

  • Forecasting and Budgeting- Provide monthly forecasts for projects and programs. Participate in annual budgeting activities as required.

Who You Are:

  • 10+ years of experience as a successful Information Technology Project Manager using structured project management processes

  • Bachelor's degree in CS, MIS, Life Sciences, Business; or equivalent experience

  • Deep understanding of SDLCs including Agile methodologies

  • Proven ability to obtain results in a matrix environment

  • Track record of delivering projects on time and on budget

  • Well versed in vendor management and can look for new opportunities to optimize our vendor contracts and relationships

  • Ability to see the interrelationship of a project across "the big picture" and understand its dependency on other projects in the program as required

  • Excellent verbal and written communication skills at all levels

  • Exceptional listening, problem solving, negotiation, and facilitation skills

  • Demonstrated success handling initiatives of high complexity and risk

Plus:

  • Understand Drug Development Early Stage/or Research (high-level) business processes

  • Basic understanding of SEND (Standard for Exchange Nonclinical Data)

  • Hands-on experience in managing data warehouse and/or data repository project that involves scientific/research data; project completed in R&D (Research and Development) setting

  • Experience managing and leading other project manager and team members preferred

  • Roche PMM methodology and/or PMI/PMP Certification

#LI-CG-MT1

Important Information

Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity protections, view the EEO is the poster.

If you have a disability and need an accommodation in connection with the on-line application process, please email us at US.Accommodation@roche.com.

Genentech will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.