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Genentech is seeking multiple interns either pursuing, or recent graduates from a MSc/PhD degree with expertise in advanced analytics to help us explore its potential applications in healthcare. The specific intern will work with the biostatistic function in product development organization in Roche. We propose to evaluate and implement a Bayesian dynamic borrowing approach to construct a hybrid control arms for ongoing and future clinical trials. This work will involve data types beyond randomized clinical trial data, including the clinical trials data and Flatiron datamart (RWD). The primary goal of the project is to provide ready to use tool and guideline for current and future clinical trials.

Qualifications

• Excellent R/Stan/Jags skill

• Solid Bayesian statistics knowledge

• Sufficient clinical trial design knowledge

• R package and shiny app development skill as a plus

The McCarthy postdoc group at SSF will focus on developing and implementing analytical and experimental strategies that maximise the value of human genetics for drug discovery and precision medicine. The research will build upon work undertaken in Dr McCarthy’s academic research program at Oxford. One major area of research interest will continue to revolve around the prioritization and functional characterization of therapeutic targets -- for example, through implementing strategies for connecting regulatory variants to their downstream targets, and the high throughput perturbation of those targets in suitable cellular systems. A second strand will involve the use of global and partitioned risk scores to stratify risk, and to capture etiological and clinical heterogeneity, and the translational application of those scores. The group will continue to develop and apply these approaches in the area of metabolic disease (in part through continued interaction with academic researchers in genetic and functional consortia), but will also seek to implement analogous approaches across the wider range of diseases of interest to Genentech. 

The successful candidate will have a PhD and/or MD from a highly reputable institution, with training in either the life sciences (biology, medicine etc) or computational sciences (maths, physics, computational science, bioinformatics etc), but with proficiency and experience that spans both. As well as a strong publication record, they will have excellent communication skills, and interest in exploiting the potential of human genetics to gain fundamental insights into the biology of disease. Postdocs in our lab work in a challenging and stimulating yet supportive and interactive environment, becoming independent scientists with the ability to lead their own research groups.

For more information about the postdoc program: https://www.gene.com/careers/university-and-early-career/postdocs

A Postdoctoral Research Fellow position is available immediately in Genentech’s Oncology Biomarker Department in the group of Mahesh Yadav to work on projects related to cancer immunotherapy. 

This is unique and rare opportunity for a post-doctoral fellow with a strong computational background to work with large biomarker data sets from Roche/Genentech’s cancer immunotherapy trials to gain new mechanistic insights into neoantigen-driven immune responses in human cancers and (Yadav et al, Nature 2014, Fehlings et al, JITC 2019). The goal will be to apply these findings in improving neoantigen specific therapies and also publish findings in top tier scientific journals. The position will have plenty of opportunities to interact and collaborate with scientists in a dynamic cancer immunotherapy community at Genentech (South San Francisco campus). 


Qualifications:

• Applicants must have a recent doctoral degree with strong computational expertise and a robust understanding in some area of biology. Preference is given for experience in immunology, oncology, genetics, or systems biology,
• The successful applicant will have a demonstrated record of innovative scientific accomplishments as evidenced by at least one first-author paper published or accepted in a top tier journal.
• Proficiency in programming using scripting languages (Perl/Python), R, and experience in standard bioinformatics toolkits and programs.
• Collaborate extensively with multi-functional teams to leverage cutting-edge technologies and expertise both internally and externally. Attend and present at international meetings and author manuscripts for publications in top-tier journals.
• Immuno-oncology PhD candidates with strong computational expertise are strongly encouraged to apply. 

What to expect from us:

• A highly functional and collaborative research environment where we aim to translate our understanding of cancer biology to develop personalized therapies and diagnostics to transform clinical practice to benefit patient health.
• Access to large clinical data sets and samples.
• Access to state-of-the-art technologies and pioneering research.
• Participation in seminar series featuring academic and industry scientists.  
• Campus-like life style with a healthy work-life balance.
• Mentored opportunities to further develop professional skills. 

Interested applicants should send their CV, a cover letter describing your research interests and a list of 3 references.

#LI-GREDGL1

Mission

As a Data & Analytics Specialist, you will work closely with multi-disciplinary teams to solve complex data problems enabling PD to transform data into actionable insights. You will partner with IT and business stakeholders to co-create data and analytics enabled solutions that help our teams fulfill our mission: to do now what patients need next.

Main Tasks & Responsibilities:

- Carries out day to day routine repair/maintenance instrument work. 日常儀器維護和維修工作。

- Installs equipment at customer's facility to ensure full functionality according to specifications. 在客戶便利時安裝儀器，確保依據說明書實現所有功能。

- Sales of Service Contracts. 勞務收入契約。

- Coordinates problem resolution with engineering, customer service, and other personnel to expedite repairs. 協同工程部，客戶服務及其他人員解決問題，加快維修進度。

- Maintains records of performance reports. 維護服務報告記錄。

- Develops service handbooks and bulletins based on field investigations, engineering changes, and overall knowledge of product. 通過現場調查，工程變化和整體產品知識創造服務手冊和報告。

- Develops and conducts training on the safe operations of the equipment and demonstrates skills to trainees, including team members, customers as well as distributors. 對員工，客戶及經銷商進行安全操作儀器的培訓和技巧的展示。

- Assists in the yearly budget exercise for Technical Service. 協助技術服務部的年度預算。

- Management of spare parts 零配件的管理。

- Interact with customers to resolve product or service problems by clarifying the customer's inquiry and complaints. 透過澄清客戶的詢問與投訴，與客戶互動以解決產品或服務之問題。

- Reporting and communicating problems with global service center of respective BA to determine the cause of the problem; expediting correction or adjustment; following up to ensure resolution and execution of required corrective actions. 與各BA之全球服務中心匯報及溝通問題，以確認問題原因、加快更正或調整，及後續追蹤以確認必要之糾正措施的決定和執行。

Job location 工作地點

North of Taiwan 台灣北部



Education 教育背景 :

Minimum qualification required is diploma in Electronic Engineering, Mechanical Engineering or Biomedical Engineering. 電子電機, 機械, 或醫工大專及以上學歷



Specific Knowledge & Skills 專業知識與技能 :

1. Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. 解決實踐操作問題及各種突發事件。

2. Able to handle computer Operating System such as Window NT and DOS.熟練操作電腦

3. Fluent in Mandarin is a must

Sr. Learning Technologist

The general purpose of this role is to research, develop and deliver the most effective and efficient distance learning and learning technology solutions to meet CMG training objectives and meet the needs of tomorrow’s learner. This role is part of the centralized CMG Training and Development Learning Design and Technologies (LD&T) team and will work closely with fellow team members and internal/external stakeholders.

We’re seeking an individual with a keen interest in emerging technologies to help us transform the way we deliver learning to our people. Must demonstrate a strong breadth and depth of skill in working with technology for learning, both digital and face to face.

Key Accountabilities:

Responsible for research & development, prototyping, piloting and embedding new technologies into our internal learning ecosystem, including production of any process documentation for its adoption. Demonstrate an innovative and creative approach to learning design and provide options for how to digitalize existing learning initiatives. Work with instructional designers to align on design approaches and collaboratively develop transformative learning solutions. Build relationships with 3rd party vendors and actively explore their platforms and tools to validate their value based on our learner solution needs. Act as an expert advisor, educating colleagues on emerging technologies as well as the best use of our current LD&T offerings, investing time to share your findings and expertise, and to help drive and develop a digital mindset. Analyze and interpret learning technology needs across CMG Training & Development and work with stakeholders across functions to understand current capabilities and areas for improvement. Proactively incorporate LD&T’s capabilities and offerings into other CMG Training & Development strategies, plans and programs. Support the LD&T function in implementing long-range visions for future initiatives, strategies, objectives and plans to optimize learning and development support to CMG. Complete all compliance training requirements. Reinforce with team the importance of adhering to compliance policies. Raise questions proactively and seek advice as needed.

At the Sr. level:

Incumbents in the Sr. Learning Technologist role are expected to demonstrate a higher level of leadership, impact and experience than that of a Learning Technologist. They are expected to:

• Assist with onboarding new team members and consistently mentor CMG Training & Development employees.
• Be involved in higher-level stakeholder management.
• Utilize expertise and experience to support Genentech stakeholders.
• Direct and manage performance of junior colleagues and/or serve as a point of escalation.
• Act as internal subject matter experts in Learning Technologies who understand and represent the long-term vision for the area.
• Provide ongoing leadership of projects and processes including management of complex matters.

Key Competencies:

Achieving Results

• Is goal-directed, persistent; driven to achieve objectives
• Holds self and others accountable for results
• Aligns behaviors to support the goals

Communication

• Reads verbal and non-verbal cues of others
• Uses appropriate methods or approaches to communicate with others
• Keeps others informed

Decision Making

• Thinks through problems clearly and logically
• Gathers information necessary to make decisions
• Makes decisions even when all information is not known

Teamwork and Collaboration

• Cooperates and supports colleagues to be successful
• Provides and solicits input and information
• Establishes and leverages relationships

Technical and Business Expertise

• Is acknowledged as an expert in the organization and acts as an advisor to those within and outside of CMG Training & Development
• Understands the challenges faced by Genentech and creates programs to address the same

Qualifications & Experience:

• Bachelor’s Degree is required; Graduate level or higher degree is preferred
• 6 or more years' experience with 4 or more years' experience in learning technologies, training and development and/or related project management preferably gained within the biotechnology or pharmaceutical industries
• Considerable experience and expertise with web and/or other learning technologies' content management tools
• 2 or more years' experience leading learning technologies' projects, includes development and management from Request for Proposal (RFP) to project completion through ongoing maintenance and development
• Considerable experience with standard project life-cycle management
• Previous field sales, field management or product marketing experience in biotechnology or pharmaceutical industries is a plus

We are seeking an exceptional Scientific Researcher/Senior Scientific Researcher to join our Biochemical and Cellular Pharmacology (BCP) Department within Genentech’s Research and Early Development (gRED) organization. The successful candidate will be responsible for supporting cellular and biochemical characterization of protein therapeutics for various therapeutic areas as part of the biologics drug discovery program in our South San Francisco location.  Specifically, this individual will need to have experience in biotherapeutic discovery and development with an emphasis on developing, validating, and executing biochemical and cell-based in vitro functional pharmacology assays to screen and characterize therapeutics, to support lead-finding and optimization efforts, as well as mechanistic characterization of candidates.  In addition, the individual will be expected to develop ex vivo pharmacodynamic and biomarker assays, incorporate assay automation in his/her daily work and employ novel assay technologies.

The candidate will function as part of a multi-disciplinary project team that will coordinate with Antibody Engineering, Protein Chemistry, Therapeutic Areas, and Translational Research groups to advance the projects’ lead molecules.  He/she will have the opportunity to present their work to project teams and senior management, and is expected to contribute to publications and present at scientific conferences.

Requirements:

• M.S. degree in Immunology, Biochemistry, Cell Biology or a related field with 3 to 8+ years of research experience in academia, biotechnology, or biopharmaceutical experience
• Proven expertise in the design, development, validation, and execution of biochemical and cell-based assays to characterize protein therapeutics
• Experience with flow cytometry, immunoassays, and the culture of mammalian cell lines and primary cells from various species
• Ability to work independently to design, execute, and interpret experiments, and also to collaborate well with project teams
• Record of achievement including publications that demonstrate expertise and knowledge
• Excellent teamwork, oral/written communication, time management, analytical, critical thinking, and organizational skills
• A passion for science and good experiences with interdepartmental and/or external collaborations

Additional desirable skills:

• Familiarity with microscopy and/or high content image analysis
• Familiarity with the multi-disciplinary activities of antibody lead profiling
• Familiarity with automated or semi-automated instrumentation

#LI-GREDES1

The Position

Position Summary:

Personalized Healthcare (PHC) creates opportunities to improve outcomes for patients today

and in the future. The Product Development Personalized Healthcare (PDP) function aims to

drive Roche enterprise transformation across the Pharma value chain by

• Accessing meaningful data at scale (high-dimensionality datasets with longitudinal

clinical trial data, real-world data, whole genome sequencing, transcriptomics, immune

system profiling, anatomic and pathology imaging data, and digital health data)

• Applying advanced analytics to accelerate insight generation
• Feeding forward insights re: disease activity/disease characterization to inform research and development decisions which improves our internal productivity and provides evidence to inform external decision-makers including patients, healthcare providers, governments, regulators and public and private payers.

As a Business Operations Leader (BOL) you will report to and work in close partnership with

the Head of the Business Management Office. You will be working in a hybrid role -- part

Project Management and Business Process Management attuned to the emerging functional

needs. In all cases, we look to you to provide strategic counsel in the form of thoughtful

input and insights, foster a collaborative team environment that excels at leveraging diversity

of thinking and expertise, apply design-thinking to challenges encountered, and disciplined

delivery to project/operational assignments. You will help define and operate functional

solutions to achieve PDP value delivery and business objectives.

Primary Accountabilities and Responsibilities

Business Manager to guide leadership team, committee, network or other forum

decision-making and achievement of shared business objectives set by senior managers and executives.

• Thoughtful planning: Gather and analyze data and solicit senior management input

to determine what is needed and desired; Leverage “SMART” goal setting; Implement

strong project management of critical path activities to set teams up for success to

achieve near-term and long-term objectives; Design, prepare for and effectively

facilitate team meetings and/or interactions (agenda setting and outcomes and action item management)

• Decision-making: Introduces fit-for-purpose decision-making framework appropriate

for the urgency, complexity of business context; Eliminates obstacles to decision making

• Relationship Building: Builds and maintain positive, trust-based working

relationships with key stakeholders; Partner with colleagues to design required

solutions to address identified gaps and emergent business needs

• Communications: Design and implement communication plans targeting relevant

individuals in the organization – individual contributors, management/sponsors and

external stakeholders

• Continuous Learning & Improvement: Promotes organizational learning from risktaking;

Fosters supportive environment to achieve change imperative; Builds in a

feedback loops to monitor leadership team/committee/network or forum “health” and

take steps to improve interaction/dynamics

Act as lead for functional operations lead and/or project manager for functional

capability development or improvement projects

• Needs Assessment: Gather data and solicit senior management input to determine

what is needed for functional and portfolio-enabling operations

• Solution/Project Definition: Partners with the function’s Leadership Team to align on

scope and desired outcomes for projects and/or functional performance objectives

• Leadership: Lead coordinated, thoughtful, fit-for-purpose solutions for both operations

and projects; Facilitate, influence teams and individuals to advance the business to

achieve stated objectives; Actively shape business process or technology solutions &

strategies to improve the likelihood of successful embedding into and acceptance by

the organization

• Goal/Value Tracking: Has system awareness of what drives value for Pharma; Leads

thoughtful planning, tracking and communication of functional/non-molecule specific

goals to ensure transparency and business impact.

• Agility: Incite and inspire others to seek sustainable and innovative solutions and

alternatives; Continuously integrate organizational priorities and challenges into

planning and execution of functional solutions/service delivery; Flexibly adapt

operations, project delivery and advisory services with the needs of the business

Skills/Abilities:

• Business excellence: Possesses system awareness of what drives value for Pharma

in order to appropriately prioritize competing business needs; Develops efficient

processes/approaches for the team based on business knowledge and proactive

collaboration with others to get things done

• Collaboration: Applies curiosity and practices continuous learning to effectively

collaborate within and across multiple organizations and with stakeholders of various

background and skill sets; Skilled in creating a respectful and collaborative team/group

environment that pursues truth and effective performance; Contributes actively to

group learning from both success and failures

• Communication: Able to simplify a complex set of components into a simple,

effective message; Proactively determines communication needs and implements change messaging and reinforcement interventions; Possesses strong executive

presentation skills and writing skills

• Initiative: Able to define priorities and focus on areas that add value; Self-motivated

and disciplined to deliver results; Asks for feedback to continuously improve own work

and that of the group; Finds ways to scale their assignments to make space for growth

opportunities

• Influencing: Demonstrated skills in persuading senior leadership on strategy,

initiatives implementation and decision-making; Possesses a strong self-awareness to

influence in varied situations and with various levels in the organization to achieve

business objectives; Has a track record of achieving outcomes that advance the

business

• Problem solver: Knows how to apply design thinking and problem solving

frameworks; Demonstrates an ability to work in unstructured and ambiguous

environments; Demonstrate ability to develop and present sound proposals and

recommendations; Brings experience in implementing and embedding solutions, not

just information-gathering to management.

• Leadership: Understands the impact of own actions to the business; Takes full

accountability for their work; Speaks up and volunteers to lead new work scope to

support team and function effectiveness; Role models Roche Leadership

Commitments and Product Development Behaviors

Qualifications:

Business Operations Leader

• Advanced degree preferred in business, life sciences, or related disciplines
• 10+ years in multi-disciplinary experience in the pharmaceutical/biotechnology academia/industry
• 5+ years proven availability to lead large-scale, complex projects –programs in a fast paced dynamic and matrix environment
• Significant experience in transforming and successfully introducing change
• Large-scale budget management
• Ability to travel internationally as needed, less than 10%

#LI-PDHB2

As a Sourcing Manager, you will be a part of the Global Procurement Region Americas team focusing on Marketing & Sales sourcing with a focus on Advertising and Production (creative agency, print/promotions, and meetings/events management) categories across Pharma and Diagnostics and is located at the South San Francisco site.

Global Procurement (GP) is a key function that delivers value to Roche by leveraging market knowledge, subject matter expertise and business insights in the procurement of goods and services and the management of Roche’s third party spend. Through collaboration with our external suppliers and internal business partners, GP helps bring innovative tests and medicines to patients.

The Americas Regional Procurement team is responsible for translating business requirements into Procurement activities and provides employees – from facilities managers, to brand teams, to research scientists – with all day-to-day procurement services. Our team represents Global Procurement to our regional stakeholders and is a key point of contact for employees to support their requirements for goods and services to sustain our business and operations. As a key link between stakeholders and the wider procurement organization, we ensure regional input and needs are considered as Global Procurement proactively develops strategies and solutions for our stakeholders’ current and future needs.

As a Sourcing Manager for the Marketing & Sales Agency and Production team in the Americas, reporting to the Advertising and Production Business Partner, Americas Sales and Marketing, you will be providing day-to-day procurement sourcing activities and will be responsible for the effective stakeholder management, project management and execution of various complex and high value operational procurement activities for business prompted, and in some cases procurement driven sourcing requests within Marketing & Sales in compliance with relevant policies, standards and operating procedures.

You have experience and knowledge of procurement and sourcing tools and the overall sourcing process and methodology, such as documenting requirements, conducting analysis and negotiations, and communicating with stakeholders and suppliers. The role has a strong understanding of Marketing and Sales stakeholder functions and category spend characteristics, and effectively establishes and develops business partnering relationship with key stakeholders to translate business needs into sourcing requirements. In addition to providing high levels of internal customer service, the role will also contribute to maximizing overall procurement savings and impact.

Your responsibilities:

1. Operational Sourcing Activities

• Perform operational sourcing activities by executing operational sourcing requests within the region ensuring a focus on efficiency and the quality of customer service.
• Understand end user requirements and leverage the applicable category buying guides and sourcing knowledge to determine the best method for driving value in meeting the requirement.
• Support the creation and review of relevant purchasing documents and communicate the status, progress, and outcomes of sourcing activities.
• Application of the sourcing process (RFIs, RFQs, RFPs) for the delivery of operational sourcing activity, including the application of eSourcing tools. Support the implementation of new processes, policies, and technologies.
• Collaborate with the requisition to pay (R2P) Procurement team to ensure that the requisitioning component of the procurement process is delivered.
• Execute escalated sourcing requests from site-based Procurement and provide a support role for site-based or regional Procurement as required.
• Responsible for maintaining information flows back to other regional Procurement and Global Category teams
• Ensure that Procurement operational targets and metrics on customer service are delivered. Track and monitor these metrics where required.
  
   

2. Business Partnering, Category and Procurement Activities

• Conduct operational Business Partnering with specific stakeholders within the region and in alignment with the Global Category and Supplier Management teams.
• Provide input and feedback on high value procurement opportunities and support the creation of Category Guides and Strategies.
• Deliver Category Strategy execution and Supplier Management activities for specific suppliers within the region and in alignment with the Global Category and Supplier Management teams.
• Support stakeholder handover to Transactional Procurement (i.e. SSC)

This position is not eligible for relocation.

Qualifications:

• University degree or equivalent work experience
• 3 - 5 years in marketing and sales business experience
• Experience and knowledge of strategic sourcing, supplier management and demand management approaches
• Experience or demonstrated understanding in supporting cost reduction and value improvement programs
• Excellent stakeholder management and communication skills and demonstrated experience in translating business requirements into procurement specifications with customer service in mind
• Experience and knowledge in procurement systems and processes for efficient management of contract documentation, templates and processing tools
• Experience or knowledge of Center of Excellence or Shared Services operating environments

Purpose:  

The Medical Science Liaison (MSL) is responsible for providing external and internal customers with clinical, scientific, and health economic information related to the appropriate utilization of products in the Genentech portfolio and with more general information about the relevant therapeutic area and disease state. This field-based position will proactively build healthcare provider, population health decision maker, and patient support, by using an approach that is aligned with the Squad objectives and of the overarching objectives of Genentech. Expertise tailored to specific customers will be expected. The MSL will need to be a credible and valued representative of Genentech in a variety of interactions with key stakeholders across their regions and accounts. In addition to these existing MSL responsibilities, MSLs will have a broader understanding of multiple therapy areas based on the squads they support, as well as be able to engage in a broad range of scientific exchanges in Neuroscience (Multiple Sclerosis, NMO, Lytics (stroke) and Alzheimer's Disease).

Key Responsibilities/Accountabilities:  

●    Representing the assigned molecules in Neuroscience (Multiple Sclerosis, NMO Lytics (stroke) and Alzheimer's Disease)  and overall Neuroscience Portfolio to the highest ethical and professional standards and in accordance with guidelines and direction across all customers

●    Build, cultivate, and share relationships with external scientific, medical, and managed care customers and advocacy organization representatives in their geographies to ensure strong understanding of evolving healthcare trends across the relevant landscape and customer needs

●    Demonstrate proficiency in topics beyond scientific exchange such as value / cost of care discussions, hospitalizations, risk of progression, drug pricing pressures, reimbursement education, patient treatment journey and AE management; actively attend and participate in upskilling training programs that grow MSL competency in role and for the future

●    Engage in continuous learning within the therapeutic area they represent, or across all the portfolio (depending on role), which includes utilizing appropriate resources to stay current with the scientific literature (e.g., conducting regular literature searches and library research), participating in various internal and external clinical and scientific education programs, meetings, presentations and other forums that provide in-depth clinical and operational expertise and insights regarding the assigned molecules, products and overall therapeutic area(s), as well as business related topics relevant to the therapeutic area

●    Be fluent in the value-based scientific information associated with Genentech products from the perspective of payers or others making population-based care decisions

●    Responding to on and off-label questions with integrity, compliance, and adherence to legal, regulatory, and Genentech guidelines, policies & procedures

●    Build and cultivate important working relationships across field partners to ensure an enterprise approach when working with customers.  Partner on Genentech account planning activities as appropriate, delivering the medical perspective for designated accounts

●    Identify and bring insights back in house to Genentech stakeholders through efficient and effective use of CRM system 

●    Assisting with Phase II - III - IV clinical trials, health economic outcomes research, other clinical studies and investigation; providing clinical expertise and feedback regarding operational management that effectively and efficiently guides clinical trials, other studies, and investigations

●    Providing clinical and value-based expertise in the development, management, and maintenance of clinical and scientific communications, including research, publications, and educational materials, meeting/event presentations and information, etc.

●    Conduction presentation and meetings with healthcare professionals and population health decision makers on disease state, clinical, scientific, and value-based information

●    Providing clinical and value-based input into Genentech communications and materials, as well as participate in/or assisting internal training & development activities

●    When assigned, identifying and completing special projects

●    Ensuring assigned goals and objectives are met and that assigned projects and other work is completed on time, with high quality, and within budget

●    Provide field support to generate applied science research demonstrating the value of Genentech products in real-world clinical use 

Additional Key Responsibilities/Accountabilities for Managed Care MSLs (MC MSLs):

●    Cultivate relationships with key access decision-makers and influencers to enhance access to and optimize formulary positioning for Genentech products 

●    Provide account relationship support to managed care account teams by identifying and developing relationships with key decision-makers in managed care organizations and other institutions that purchase, influence or manage the use of Genentech products

●    Participate in other segment initiatives (employers, pharmacy benefits management organizations, etc.) to provide medical expertise internally and externally to support optimized access and formulary access

Example Responsibilities in the MSL position, you will:

●    Focus the majority of time in the field with customers, including patients, advocacy groups and other stakeholders who are a part of the Neuroscience patient treatment teams

●    Support your player / coach Field Leads,  medical directors, and peers in gathering information, analyses, research and reporting to support national, regional, and local tactical planning

Requirements/Qualifications:

Candidates for this position should hold the following qualifications, have the following experience, and be able to demonstrate the following knowledge, skills and abilities to be considered as a suitable applicant. Please note that except where specified as “preferred,” or as a “plus,” all points listed below are considered minimum requirements. Years of experience listed below can be substituted with equivalent, relevant competency levels

●    Advanced Clinical/Science Degree is preferred (e.g., MD, PharmD, PhD, MSN, MPH, etc.)

 

Knowledge: 

●    GCP (Good Clinical Practice) and ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) proficient

●    In-depth knowledge of Phase IV/post-marketing drug development is preferred, Neuroscience and break-through, fast-track familiarity a plus

●    Understand Neuroscience regulatory and treatment pathways, patient access, advocacy and associated regional and socioeconomic differences in the United States that lead to the creation of unmet need in these small yet important patient populations 

●    Relevant therapeutic area knowledge, dependent on customer base

●    Comprehensive understanding of product and safety profiles

●    In-depth knowledge/understanding of managed care, health economics, healthcare reimbursement, managed care customers and the distribution channels relevant to pharmaceutical/biotechnology organizations

●    Familiarity with the current legal and regulatory landscape pertinent to the pharmaceutical/biotechnology industry

Required Experience: 

●    Minimum of 5 years related work experience (clinical, managed care, or industry experience)

●    Prior experience as a field medical science liaison is preferred

●    2 or more years’ clinical or health economic research experience (either in industry or in another, related setting) is preferred

●    2 years' experience in therapy area is preferred

Skills:

●    Ability, effectiveness and high degree of comfort and confidence in engaging with patients, patient advocacy groups, support and care-giver population

●    Excellent communication and presentation skills; exhibits professional maturity, confidence, and competence. Strong conflict resolution skills; proven ability to effectively and quickly achieve conflict resolution with affected parties.

●    Ability to summarize and communicate complex information and business objectives in a concise and effective way for important decisions and tailor communication to the right audience for maximum effectiveness and understanding

●    Embraces change, embodies a continuous improvement mindset, and exemplifies agile principles in day-to-day activities

●    Ability to learn other disease or product areas as business needs and product life cycles change

●    Outstanding organizational and time management skills; proven abilities to manage multiple, often complex and sometimes competing, objectives, goals and other priorities to effective and efficient conclusion

●    Proven track record of meeting or exceeding objectives and goals 

●    Strong attention-to-detail

●    Learning mindset, open to training and becoming an expert across customer types or multiple therapeutic areas 

●    Outstanding business acumen; knows the industry, Genentech's business model and value proposition, key competitors and other marketplace factors/dynamics

●    In addition to passing Genentech's background screening, the employee must submit to and pass additional background screening as required by some institutions and health facility sales accounts (additional screening requests may include but are not limited to background checks, immunization, TB, HIV, hepatitis, and drug screening) 

●    Business travel, by air or car, is required for regular internal and external business meetings (up to 70% of time)

●    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. The person selected must reside in WA, OR, ID, MT, AK, WY.

#LI-COMMCG2

Job Description Summary

This position is part of Genentech’s’ Pharma Technical - individualized Neoantigen Specific Therapy (iNeST) team based in Hillsboro, Oregon.  iNeST is a next generation immunotherapy for the treatment of patients with cancer manufactured on a per patient basis.  In this critical role, you will be part of a dedicated cross-functional team working on production start-up activities such as the design, installation, testing, and validation of equipment, processes, and the quality approach for this exciting and novel technology. 

As the Principal Engineer focusing on Validation Engineering, you will be supporting the design and start up of a GMP facility capable of manufacturing high throughput individualized therapies, you will help define the requirements for operational equipment and processes and will establish business processes that enable the organization to operate successfully.  This role provides the opportunity to closely partner with the existing clinical facility, the iNeST User Team, Engineering Team and Process Technical Development as you work on start-up activities for the new cGMP facility, processes and equipment.  You will be accountable for oversight of the validation lifecycle from Plan to Retire, for manufacturing processes and equipment.  This includes oversight of Equipment Qualification and Process Validation as well as development and administration of the Periodic Review and Revalidation program.   You will also provide technical leadership, guidance and support to the process engineers that will take guidance from you in performing validation activities. You will also represent the validation program during health authority inspections.  The successful candidate will have a demonstrated passion for simplification and the application of risk based decision making to streamline validation activities.

 Key Responsibilities

• Develop and co-own the site validation strategy with site Quality.  Drive for simplification and application of risk based validation.
• Partner with Quality, Global Engineering and the iNeST project team to drive completion of validation activities through handover.
• Accountable to lead the execution of Validation activities from handover through qualification and licensure of the iNEST facility.
• Apply quality by design principles during the validation lifecycle to ultimately reduce overall validation efforts and increase chances of success during validation
• Provide technical leadership and guidance for the process engineers executing validation activities. 
• Author, review and approve GMP documentation and regulatory submissions.
• Provide leadership on projects, process improvements, and teams.
• Actively contribute to effective teamwork and quality decision-making.
• Oversee validation activities performed internal staff and contractors. 
• Collaborate with PTQ on validation standards and implementation of quality policies.
• Provide input during process design activities to ensure robust validation.
• Ensure that staff works in the safest possible manner
• Ensure compliance with cGMPs.

Qualifications/Requirements:

• Minimum of BA/BS in engineering or science.
• Minimum of 12 years of biopharmaceutical industrial experience
• Expertise in the qualification and validation of pharmaceutical manufacturing equipment, lab equipment and pharmaceutical manufacturing processes.
• Demonstrated ability to lead, motivate and sustain creative output from a diverse technical staff.
• Expertise in the application of statistical methods to develop robust validation methodologies.
• Strong written and verbal communication, interpersonal, leadership, and team skills
• Successful demonstration of goal setting, delivering results, staff development, technical expertise, problem solving, training, recruiting, influencing, initiative and quality decision-making.
• Ability to travel up to 25% to support knowledge transfer and collaboration between teams in multiple locations.  More than 25% travel may be required in the first year.
• Extensive experience with start-up and validation of manufacturing equipment, utility and process systems, including requirements for documentation and testing
• Builds trustful and effective relationships
• Able to think innovatively and translate ideas into actionable plans
• Takes responsibility, drives results, and achieves expected outcomes
• Work in office, production and laboratory environments
• Lift up to 25 lbs may be required
• Ability to sit, stand and move within work space for extended periods
• May be required to sit at a computer terminal for extended periods

Relocation is not designated for this position.

*Considering Local Candidates Only*

The statements made in this job description are intended to describe the general nature and level of work being performed by those persons assigned to this job. These statements are not intended to be an exhaustive list of all responsibilities, duties and skills required of people assigned to this job.

Position Purpose

The Compliance Process, Training and Systems (CPTS) team within CCO provide clinical trial GCP expertise, process/systems and training support across CCO and to clinical operations staff in the wider affiliate network, in collaboration with other global functions (e.g. SPE, SQT2, PDMA, PDQ).

The role of the CPTS Advisor is to implement the local CPTS strategy in line with the global CPTS direction and to provide GCP expertise to country clinical operations teams.  A key member of the local and regional hub (where applicable) CPTS team, responsible for delivering CPTS tactics that ensure the delivery of fit for purpose processes, systems and training support to clinical operations, enabling efficient and GCP compliant clinical trial delivery.   Ensuring business objectives (e.g. LSPC and study goals) are met.  

Establishes effective local and regional partnerships (e.g FSP Partners, LQR, Medical Affairs, etc.) to ensure the needs of their clinical operations teams are met.  Proactive identification and effective management of clinical trial GCP compliance, process, systems and training related risks, issues and inefficiencies.  Embeds a culture of GCP compliance and continuous improvement in their country and, where appropriate, the wider regional affiliate group through the country hub structures.

Main Accountabilities and Responsibilities

Implements CPTS Tactics that Drive for Impact:  As a key member of the CPTS and country clinical operations teams, delivers CPTS activities related to GCP compliance, process, systems and training support to ensure the country clinical operations teams meet current and future business needs and study goals:

Responsible for making decisions around CPTS deliverables and empowered to take ownership to drive impactful results Locally delivers CPTS tactics that enables clinical operations to achieve GCP Inspection Readiness status in alignment with global and regional plans/goals.  Embeds a continuous improvement culture in clinical operations in the country Facilitates cross-country alignment, information sharing and best practices within the regional CPTS team, driving local and regional efficiency Builds influential partnerships with key internal and external local and regional stakeholders to ensure that country clinical operations business needs are met and identified risks/issues are swiftly and effectively managed by accountable functions (e.g. SPE, SQT2, PDQ, IQVIA, Medical Affairs) Anticipates the needs of country clinical operations teams and implements changes in strategy or tactics when needed to improve the effectiveness of CPTS Provides GCP, process, systems and training expertise for functional improvement initiatives. May lead or provide subject matter expertise to continuous improvement initiatives.

Operational Support: Drive improvements in the local implementation of GCP excellence, systems/process and training support to country clinical operations and to the wider regional affiliate network (as appropriate).  Working in close collaboration with regional and global teams to ensure that systems/process and training is effective and fit for purpose for local clinical operations teams, ensuring compliance to local laws and regulations.

Identifies and escalates via established networks local needs that may require global solutions to enable Inspection Readiness. Development and maintenance of local CPTS business processes for local clinical operations, partnering with GPOs and functional BPOS where appropriate In close collaboration with global and regional teams (e.g. SPE, SQT2 and PDMA) delivery of CPTS process, systems and training support.  May act as a local or regional subject matter expert (SPOC) for a specific focus area e.g. GCP, systems, process or training Provides local support for audits and inspections related to clinical operations, country and investigator site management Provides GCP subject matter expertise, working in collaboration with clinical operations teams to identify and effectively manage GCP related risks and issues.  Partners with clinical operations teams to ensures adherence to key processes, systems and initiatives in the Country to ensure inspection readiness Share local business insights and quality management tactics by utilizing multiple sources of information to identify trends and risk (e.g. system reports, help desk data, inspection reports, audit findings, CAPAs and internal/external benchmarking data) to implement effective actions to mitigate risks and ensure inspection readiness May play a role within the oversight of the FSP, responsible for proactively identifying, managing and, where appropriate, escalating risks and issues related to GCP compliance, process, system and training.  May participate as an active member of the Local Medical Compliance governance model (if applicable), representing the GCP pillar, as needed and provides input into medical compliance risks and issues related to compliance, process, systems and training.  Work closely with the regional CPTS team enabling CCO to operationalize new process, initiatives and drive continuous improvement Has an awareness of, and manages ongoing changes to regulations, guidelines, ICH-GCP standards and global processes Collaborates with key stakeholders and managers, as applicable, to ensure that all staff are appropriately trained and supported regarding the Roche global and local procedures and systems. Ensures CAPAs derived from Audits and Inspection reports for GCP related findings are effectively implemented, in order to mitigate impact in key high risk areas and best practices are shared across the affiliate and/or sub-region Proactively identifies, and in collaboration with global and regional teams, implements improvements to systems, process, training or tools to achieve quality standards and efficiencies

Experience, Skills, Knowledge Required

• Expert knowledge of ICH GCP and local regulatory requirements.

Competencies

• Planning and organizing
• Facilitating change

• Building partnership

• Building customer loyalty and service delivery
• Decision making
• Influencing

Other:

• Availability to travel internationally.

The Communication & Engagement team designs and manages internal communications for the Genentech U.S. Commercial, Medical Affairs and Government Affairs (CMG) organization in order to inform, inspire and engage employees.

We are currently looking for an experienced executive and internal communications professional who is passionate about shaping the employee communications experience to join our team. The right individual will be able to strategize, collaborate with stakeholders, counsel and synthesize one minute and execute the next. This individual will work closely with internal communication teams, CMG leaders and partner to lead on internal strategic communication campaigns, change communication, to come up with innovative ways to engage employees and to write communications, business update presentations and talking points.

Key Responsibilities:

• Act as a primary contact for all assigned CMG Communications projects in designing and implementing communications strategies, plans and tactics. Define, scopes and structures CMG Communications projects and other ongoing. assignments/responsibilities, including effective and efficient project management oversight of internal and external partners and vendors.
• Provide in-depth communications expertise and outstanding customer service to senior leaders, internal stakeholders and other customers. Work closely with internal communications teams and leaders and partner with communications operations team to lead efforts around people, culture, strategic communications, campaigns and initiatives.
• Assume responsibility for assigned communications projects and/or other specific ongoing CMG Communications responsibilities and assignments, which may include some or all of the following:

• Develop communication materials (initiatives, strategy, plan and tactics' documentation), reviews with key stakeholders and managing from end to end. Materials include, but are not limited to: CMG executive business presentations, executive communications, meeting/event agendas, speaker materials and notes, and content for the CMG portal and newsletter.
• Interact and influence executives and provide advice that reflects an understanding of their leadership and business style.
• Write compelling messages for leadership and create thoughtful presentations for internal meetings and coach leadership to communicate in written (narratives, emails, articles, posts) and spoken (speeches, presentations, podcasts, videos) forms.
• Manage the design, production and maintenance CMG intranet portal (as a communication vehicle/device).
• Develop creative strategies for communicating to employees and identifying topics and developing content with speakers for large CMG forums/meetings (e.g., preparing talking points for CMG leadership at national internal meetings and providing staff support to engagement efforts, managing the design and production of CMG Town Hall meetings, etc.).
• Manage the process to provide formal CMG reward and recognition to employees.
• Establish KPIs and assessing channel effectiveness.

• Lead change communication efforts for CMG programs as well as drive messaging and narrative development.
• Lead in the identification and contracting of external vendor partners to support assigned communication projects and responsibilities, if needed.
• Develop detailed project plans, which includes core deliverables, responsible parties, interim review meetings and full implementation plans.
• Develop success metrics and shares results with the communication operations team, stakeholders and leaders.
• Lead and/or participate in cross-functional communication planning and development meetings. Ensures timely follow-up and completion of all assigned tasks.
• Monitor communication projects and ongoing responsibilities to measure and regularly track progress. Where appropriate, provide regular updates or other reporting on progress and performance of assigned communication responsibilities.
• Review overall functional processes, procedures, tools and other resources continually to ensure best practices, optimal efficiencies and effectiveness for communications support to CMG.
• Support, as needed, wider goals, objectives or projects. If needed, act on cross- functional teams assigned with a specific mission or role, and in other such capacity to represent the CMG group.
• Comply with all laws, regulations and policies that govern the conduct of Genentech activities.
• Participate in business travel, by air or car, when required for regular internal and external business meetings.

Qualifications and Experience: unless stated as "preferred" or "a plus," all other criteria is required

Bachelor’s degree (general business, public relations, marketing and/or communications disciplines are preferred).

MBA or other related graduate-level degree is preferred.

Experience in Diversity and Inclusion strategies, activities, and communications is preferred.

Previous corporate communications or communications agency experience required and marketing experience is preferred.

Average of 4 or more years of multi-disciplinary work experience.

A minimum of 5 years of previous communications or public relations experience, with 3 years of experience gained in the pharmaceutical, biotechnology or related industry. Experience with change communications preferred.

Communication Skills

Demonstrated superior communications skills, both written and verbal; with particular emphasis on business-writing skills and active listening (proven abilities to communicate effectively and efficiently with various cross-functional partners, stakeholders and senior management).

Experience writing executive communications and presentations, including handling confidential and sensitive topics.

Strong creative ability, outstanding story-telling (via multiple formats), business

and technical writing skills and excellent editorial judgment.

Strategic Agility

Experience creating strategic communications plans, leveraging multiple communications and engagement channels, particularly during times of changes. Creative problem-solver, with the ability to think, plan and execute on multiple project autonomously and in an organized fashion, balancing the long-term and immediate needs of the team.



Knowledge of the healthcare industry and the ability to bring this knowledge to bear when advising stakeholders and partners on communications strategies, plans, objectives, tactics, implications and impact.

Influencing & Collaboration

Strong consulting skills with the ability to quickly assimilate business needs and circumstances and effectively advise others.



The ability to influence others without authority; excellent partnering skills; and the ability to work collaboratively, effectively and efficiently with internal and external partners and stakeholders.

Strong executive presence with a history of cultivating strong and trusting counseling relationships with executive leadership.

Strong customer-orientation and proven track record of collaborative work relationships.

Strong track record in managing external vendor partners and other internal

colleagues in the execution of communications strategies, plans, programs and events.

Achieving Results

Outstanding time-management and organizational skills, with an ability to consistently execute multiple, and sometimes competing, activities and complex projects to high- quality conclusion, on-time and within budget.



Proven track record for meeting or exceeding objectives and goals, demonstrating outstanding attention to detail and acting with urgency as appropriate.

Who We Are

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.

Genentech is an equal opportunity employer and 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, visit our Genentech Careers page.

Responsibilities will include:

• Closely collaborating with R&D and Global Product Strategy leaders to define areas of interest and to develop and execute the partnering strategy for those areas

• Sourcing new therapeutic opportunities that are consistent with the company’s scientific and business objectives, including preparing in-depth opportunity landscapes, attending scientific and partnering conferences, and networking with biotechs, venture capitalists, academia and biopharmaceutical companies

• Driving decision-making and the deal process, and making presentations and recommendations to senior management

• Leading scientific and strategic assessments and cross-functional due diligence reviews 

• Developing and recommending proposed deal structures and financial terms, and leading negotiations of term sheets and contracts with potential partners in collaboration with Legal and Finance

• Coaching and mentoring other BDPLs on all aspects of the deal process

• Travel as needed for negotiations and for building coalitions of support for key deals within Genentech and across Roche

Requirements

• An advanced degree in life sciences, medicine or data science.   An MBA or JD, or an equivalent combination of scientific and business education and experience is helpful, e.g., strategy consulting experience.

• High level of expertise of business development or transactional experience with a track record of leading and successfully completing complex or high impact transactions in life sciences, diagnostics or personalized health care; experience with both preclinical and clinical therapeutic opportunities preferred

• Proven ability to build and lead teams, drive business decisions, and manage multiple projects effectively in a fast-paced environment 

• Energetic, result-driven, self-starter with a strong executive presence, collaborative mindset, and ability to think strategically and analytically

• Solid understanding of the drug/technology/diagnostic discovery, development and commercialization process, and demonstrated ability to effectively collaborate with R&D leadership; knowledge of the therapeutic and partnering landscape within a sector of interest to Genentech/Roche is a plus
  
   

• A verifiable reputation of integrity, resilience, fairness, collegiality and passion for supporting difficult, data-driven decisions in support of driving or walking-away from deals

• Good business instincts and fluency with business analytics and valuation methodologies

• Superb oral and written communication, interpersonal, influence and negotiation skills

• Skillful presenter of scientific and business topics to executives

Length: 1 Year

Start Date: TBD

Responsibilities:

Intact & Cross-Functional Teams

• Participates in site and/or regional PD Regulatory Disclosures departmental meetings
• As needed, advises as an ad hoc member in Regulatory Affairs Functional Teams (RAFT) for assigned product development projects. Represents Regulatory Disclosures and supports effective and efficient cross-functional PDR coordination, appropriate resources, and timely, thorough and compliant execution
• As assigned, may act as a standing or ad hoc member of other teams for special or ongoing initiatives and projects

Regulatory Disclosures

• Performs adhoc business analysis leveraging business analysis tools to enable team track and plan work efficiently
• Demonstrates quick learning and capability to understand business data and processes spanning across Roche systems
• Helps team with building tool capability, communication and resources for operational efficiencies
• Obtains and applies in-depth knowledge of Roche and regulatory guidelines, procedures and best practices
• Identifies studies required for registry and results postings, including applicable trials for results postings on relevant external websites
• Works with cross-functional team members to obtain data, reviews and approvals required for completion of registry and results entries on internal and external websites
• Monitors workflows for registry and results entries to ensure timely and on-target completion
• Completes document and data uploads in applicable systems
• Tracks correspondence with cross-functional teams and departments via departmental mailboxes and ensures appropriate responses are provided in a timely manner

Other

• Participates in and/or otherwise supports development and implementation of new or updated PDR and/or Regulatory Disclosures-specific systems, processes or other relevant tools
• Completes routine and ad hoc analysis and reporting. Responsible to keep all internal customers, partners and stakeholders abreast of progress and interim updates. Does so by following prescribed departmental procedures, practices and protocols and by using standardized reporting and communications tools/templates and other resources
• Participates in other special projects, as and when assigned, or otherwise requested
• Participates in routine and ad hoc departmental meetings and other business reviews or meetings to remain, at all times, fully abreast and apprised of evolving internal and external needs and requirements. Expected to share best practices within the department and cross-functionally, identify and communicate opportunities for departmental enhancements and efficiencies
• Consistently complies with all governing laws, regulations, Roche SOPs and other guidelines

Qualifications:

• Bachelors Degree preferred (life sciences disciplines strongly preferred)
• Average of 3 or more years’ relevant experience in the pharmaceutical/biotechnology industry. Some previous experience in regulatory affairs or other product development functions is preferred
• Business analysis tools experience eg Tablaeu, Spotfire etc
• Medical writing and/or editing experience is preferred
• Some understanding of international regulations, processes and issues in drug/biologics development is preferred. Includes GxP (Good Practices for quality guidelines and practices in the pharmaceutical/biotechnology or related industry), GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant guidelines
• Some understanding of product and safety profiles
• Strong computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel) and Adobe Acrobat
• Fluent English and other language skills as needed

Desired Abilities:

• Has impeccable ethics.
• Outstanding attention-to-detail
• Has working knowledge of the multidisciplinary functions involved in pharmaceutical/biotechnology product development, e.g. clinical development, clinical operations, biostatistics, commercial operations, etc.
• Excellent project management skills: can prioritize multiple tasks and goals to ensure the timely, on-target and within-budget accomplishment of such
• Good interpersonal, verbal communication and influencing skills: can influence without authority
• Strong written communication skills
• Good business presentation skills: is comfortable and effective when presenting to others, internally or externally
• Good negotiation skills: knows how to complete deliverables by working effectively with others internally and externally
• Good judgment and decision-making skills: knows how to make trade-off decisions while balancing ethics and efficacy
• Works well within teams and is effective in collaborating with others internally and externally
• Ability to travel

Main Purpose of the Position:

Logistics Specialists in the Hillsboro Warehouse and Distribution department are responsible for the execution of product logistics in a cGMP environment.  This includes the receipt, storage, and issuance of GMP raw materials used in production and marketed product distribution to our customers.  Other responsibilities included performing data entry into various business systems and databases ensuring department compliance with policies and procedures.

 

Responsibilities:

• Accurately pick, pack, and ship product against customer orders
• Using manual labor, pallet jacks, and forklifts, move GMP product and non-GMP supplies from storage locations and to delivery trucks
• Using a company vehicle, transport materials and equipment between sites (if applicable)
• Perform all work activities in a safe and compliant manner according to all Genentech policies, procedures and trainings
• Perform physical cycle counts of product and materials
• Access various business systems and input data with a high level of accuracy
• Record creation, collection and storage per corporate retention schedules
• Perform department related project activity that may include investigating, analyzing, formulating possible solutions, documenting processes, and communicating results

Qualifications / Requirements:

• BA or BS degree in Business Administration or related fields or equivalent job experience is preferred
• Ability to follow detailed verbal and written instruction
• Good basic mathematical skills
• Ability to repeatedly lift 50 lbs
• Proficiency with PC desktop applications and business operations software system
• Ability to work in a highly cooperative and dynamic environment
• Flexibility in assignments and able to work over-time, holidays, weekends and different shifts as required to meet business and customer needs
• Strong organizational, communication and interpersonal skills
• Valid driver’s license with acceptable driving record (if applicable)

Number of Positions: 4

Shifts: Front Days, Front Nights, Back Days, Back Nights

The Facilities Lead has overall responsibility for leading an organization of approximately 12 employees in life-cycle management and maintenance of all site equipment and facilities, utility systems operations and site services at the Vacaville Drug Substance Manufacturing Facility to maintain GMP/regulatory compliance.  The Facilities Lead will report to the Head of Facilities and Engineering and be responsible for overseeing their staff as they provide technical support, routine maintenance and problem solving capabilities including equipment troubleshooting and utilizing equipment trends to ensure reliable system performance in a GMP environment.

Technical:

• Provide GMP/regulatory compliance, technical direction and leadership to their organization which consists of Utility Operations, Scheduling, Maintenance and Instrumentation to support facility operations.  
• Direct and provide guidance on facility matters to ensure all site buildings, facilities and utilities are safe, compliant, reliable and efficient, delivered according to customer expectations. 
• Interact with key customers and stakeholders and keep them apprised of priorities, status, continuous improvement initiatives.
• Partner with key customers and calibration vendors to align on and implement service and efficiency improvements.
• Drive quality and on time performance, ensure all aspects of day to day operations are reliable, efficient and meeting right to operate compliance
• Oversee equipment SOP reviews and ensure that they are accurate, compliant, safe and updated, including GMP SOP’s.
• Ensure on time execution of work orders.
• Oversee and provide direction for instrumentation and calibration support of GMP production.
• Identify opportunities for continuous improvement and pursue changes and upgrades to processes and procedures as warranted, including optimizing the maintenance strategies and calibration intervals.
• Ensure all safety LOTO procedures are accurate and followed.

Leadership:

• Create an environment of strong team spirit, timely and effective communications, sense of urgency, high motivation and inspire team to achieve goals in the immediate and longer term. 
• Manage and administer people processes including selection, hiring, promotion, and compensation and provide training of personnel on company and department policies systems and processes.
• Build a culture of continuous improvement and model lean leadership principles.

Financial:

• Manage annual budget, revise forecasts to meet business needs and monitor/control expenditures to assure efficient use of company resources.

 Job Requirements:

• Bachelor’s degree in technical field required.
• 10- 15 years’ managerial experience in a bio-pharma environment required
• 8-10 years’ people management experience, preferably within facilities management
• Extensive experience working in a cGMP environment, relevant to the pharmaceutical industry.
• Demonstrated experience and knowledge of facility and engineering operations and processes. 
• Deep experience with GMP compliance
• Experience in Lean Manufacturing environment a plus.
• Strong leadership, collaboration and influencing skills, with demonstrated ability to problem solve and drive positive change.
• Strong verbal and written communication skills.

Basic Function:

The SPA Global Lead – Early Development, Oncology or I2ON in the global Statistical Programming group strongly impacts the strategic direction of the global statistical programming function and ensures those strategies are understood and applied to the Early Development portfolio within the specific TA in a timely manner. S/he has responsibility for all statistical analysis and programming advice and services for the pRED and gRED organizations within a specific therapeutic area (e.g. Oncology or I2ON).   These directly impact the strategic direction of the RED organizations and influence their decision-making. Typically the Global Lead’s accountability extends across multiple early phase molecules and one or more disease areas.

Role Responsibilities:

Leadership and Strategy

• As part of the SPA Oncology or I2ON TA Leadership Team, participate in the development of its global strategy and the execution of its mission. 
• Leadership point of contact within TA for senior leaders in gRED/pRED and other Early Development stakeholders within the region.
• Provide leadership on business aspects of cross-functional initiatives, especially with regards to statistical programming, early development, TA knowledge and technical implementation of data processing and analysis reporting procedures relevant to the functional area.

People Development and Management

• Line management responsibility in a global setting for individual contributors and first-line managers, including setting of individual accountabilities and objectives and performance evaluation on an ongoing basis and at regular review sessions. 
• Coaches SPA managers and individual contributors, for example by the use of informal regular project reviews or preparation for cross-functional review meetings and by reviewing project deliverables
• Ensures continued career development for direct report and on-going development of their reports through selection of work assignments and on-going coaching and training
• Participated in talent planning and ensure appropriate skill development
• Assist in with the establishment and cultivation of innovation and continuous process/efficiency improvement

Functional Responsibilities

• Monitor and understand the impact of Company, Biometrics and Therapeutic area strategies on the Statistical Programming organization and deliverables
• Builds and maintains strong collaborative relationships and effective partnerships with key cross-functional colleagues (e.g., peer managers in other functions)
• Ensure process implementation for the Early Development along with appropriate measures to monitor impact and identify corrections as needed
• Ensure projects and efforts are appropriately staffed through workload planning with SPA managers in collaboration with the Infrastructure business alignment (IBA) group. Work with the larger organization to optimally utilize the global programming resource pool to meet the needs of multi-function customer base.
• Development and maintenance of relationships with other functions and customer groups  

Skills:

• Excellent leadership skills, demonstrated ability to build effective, collaborative teams
• Demonstrated ability to effectively communicate corporate strategies within and across functions
• Experience in leading strategies that impact multiple functions
• Recommend, lead, and implements change efforts
• Understand functional technologies and identify areas for technical improvement
• Identify areas for improvement and oversee complex analysis that involves other functions within Biometrics to implement improvement 
• Effectively use presentation skills to convey strategic direction
• In-depth knowledge of GCP, international regulations, guidelines and their application to SPA function
• Deep understanding of SAS and SAS products as well as other statistical and visualization software, such as R, Spotfire
• Maintain understanding of functional, industry, and relevant trends
• Comprehensive understanding of conceptual basis for statistical programming and analysis conventions, standards, and processes
• Skillful in interacting with many levels of management across multiple functions
• Ability to develop staff through coaching and mentoring
• Effectively lead/manage teams globally

Background/Experience and Education:

• Bachelor or advanced degree in statistics, biological sciences, computer science or other equivalent discipline and experience. 
• At least 8 years relevant experience in clinical research with emphasis in the development and support of the analysis of clinical data.  At least 3 years of management and development of a team comprised of statistical programmers. 
• Knowledge and experience with international clinical research and drug development, especially in early development environment. 
• Good knowledge of English in a business environment.

The Department of Molecular Biology has an exciting opportunity for a Scientist/Senior Scientist with a strong background in viral vector engineering and application, genome editing, and/or synthetic gene circuitry.

The successful applicant will lead a highly dynamic research team focused on developing and applying technologies for in vivo/ex vivo genetic manipulation and cellular reprogramming. (S)he will establish an independent research platform as well as collaborative studies across therapeutic areas. In addition, the Scientist/Senior Scientist will develop tools, in vivo models, and genetic screening methods to advance broader drug target discovery and validation efforts. The successful applicant will be expected to present their research externally and publish in peer-reviewed journals.

Requirements:

A self-motivated candidate with a PhD and/or MD as well as post-doctoral expertise in Genetics, Molecular Biology, Biochemistry, Cancer Biology, Immunology, Regenerative Medicine, Neurobiology, Genome Engineering, Cell/Gene Therapy, or related disciplines. Qualified applicants will have demonstrated leadership capabilities and successful, documented application of molecular genetics/genome engineering in model organisms and/or primary/stem cell systems as well as a thorough understanding of cell/tissue specific gene delivery and expression. Preferred expertise includes some or all of the following: DNA/RNA nucleases, 2D and 3D cell culture, primary and/or stem cell model generation/differentiation/application, molecular cloning, RNA/DNA/protein quantification, epigenetics, gene network manipulation/perturbation, and viral vector (AAV, lentivirus, retrovirus) engineering/production/use. Working knowledge of pooled vector-based screening, Next-Gen Sequencing (NGS), biostatistics, and/or basic bioinformatics is desirable.

The successful candidate will have demonstrated a sustained record of productivity and scientific contributions beyond his/her postdoc, as evidenced by consistent high-impact publications, patents, and/or external presentations. All candidates will be expected to have excellent organizational skills, an ability to prioritize effectively, be team-oriented, collegial, and have strong interpersonal and communication skills.

#LI-GREDGL1

Genentech is seeking a computational chemist with experience in target discovery or validation, structure-based drug design, ligand-based design, and cheminformatics to join our Computer-Assisted Drug Discovery group in the Discovery Chemistry Department. You will be an integral member of interdisciplinary drug discovery project teams, where you will apply virtual screening, computational chemistry, informatics, and data-mining methods to help drive hit discovery and lead optimization.  You will also be involved in helping to improve our “best of breed” combination of computational chemistry and cheminformatics software applications and workflows. You will work closely with our Structural Biology, High Throughput Screening, Discovery Biology and other groups.

You will have access to state-of-the-art hardware, software, and infrastructure support in a fast-paced and creative environment.  Based at our beautiful South San Francisco campus, you will join our team of computational chemists, cheminformaticians, and software engineers who are committed to validating disease-related targets and discovering new medicines to address unmet medical needs. This is a tremendous opportunity to do impactful work in an exciting, dynamic environment.

Requirements:

• Ph.D. or equivalent in Chemistry, Chemical Biology, Biochemistry, Biophysics, or related discipline with 2-5 years experience post Ph. D.

• Experience in computational chemistry, along with a strong foundation in physical organic chemistry, is required

• Knowledge of bioinformatics and structural biology (in particular how organic molecules interact with pockets on proteins or other biomolecules) is highly desirable

• Ability to give full talks about your work and relevant external developments in the field

• Sustained independent thought and creativity in science

• A solid record of accomplishment in your field as evidenced by lead or co-authored publications, patents, and internal reports

• Excellent interpersonal, verbal, and written communication skills

• Self-sufficient in scientific scripting and/or programming

• Practical, working experience with computational chemistry software from companies such as Chemical Computing Group, Dotmatics, Schrodinger, OpenEye, and Gaussian

• Industry or academic experience in small molecule drug discovery is advantageous

#LI-GREDGL1