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Genentech Access to Care Foundation (The Foundation)

Purpose:  The Lead Forecast & Workforce Planning delivers a complete line of site across The Foundation forecasts through a stand-alone, systemized and analytic methodology.  The role is required to develop integrated product and portfolio forecasts and plans to support The Foundation and inform decisions for volume forecasts, workforce planning, SAP, COGS, PACT and donations. The role provides analytics to help in The Foundation strategy development.

This position reports directly to the GATCF Lead.

Key Responsibilities/Accountabilities: 

• Provides forecasting and predicts market event trigger scenarios on the product portfolio utilized within GATCF to the Donor, the Board, Finance and The Foundation

• Manages all internal and third-party shipping and inventory reports in a standardized and systemized format, while meeting audit-related corporate finance reporting needs. This includes appropriate data field requirements, data field reconciliation, timing/frequency of reporting, and any other checks/balances.

• Manages significant operating budget, including COGS reporting and workforce planning, based on incoming patient demand to The Foundation with predictive forecast modeling

• Informs GATCF Lead and partners with Process Excellence and Patient Program Manager on workforce planning scenarios to manage patient demand, which includes determining FTE capacity modeling based on required tasks to manage all service requests for inbound/outbound call management

• Leads all data source consolidation and reporting management with various internal stakeholders, which includes automating reporting using homogeneous reporting fields for GNE reporting needs

• Manages portfolio donations, operation costs, and headcount requirements comparable to most large franchises within the organization, e.g. Director roles within Corporate Finance, MCCO, franchises, PD organization, Manufacturing operations

• Manages and optimizes donations from the Donor to ensure the Foundation is performing within the budget put in place

Problem Solving & Decision Making:  The leader manages all financial and workforce planning needs to ensure all stakeholders vested to The Foundation can make well-informed decisions for portfolio inventory management, funds required from the Donor for portfolio shipments to patients, and necessary workforce requirements to manage the demand of service requests for The Foundation in an efficient manner. The Foundation requires this leader to build analytic capabilities in a systemized and standardized fashion to appease all stakeholders with minimal error left to manual manipulation. This is required to make better budgeting decisions for portfolio donations, headcount requirements, and operation requirements, while meeting our reporting requirements for auditing and compliance purposes.

Strategic Responsibility:  This role builds and delivers analytic capabilities for The Foundation to manage all financial and headcount requirements by anticipating external market event triggers, such as co-pay accumulators and biosimilars.  The role will also anticipate internal triggers like new product launches or changes in The Foundation policy on inclusion criteria.  This lead provides business analytics support to the Foundation, while proactively identifying risks and ways to mitigate them.

Interaction with Others:  The leader will work with and inform various Genentech Leadership Team members on an ongoing basis including: the Donor, the Board, The Foundation LT, MCCO LT, MA&S, Finance, CO, KDC / HDC and franchise LT.  The role will also manage and work with third parties required for the financial management of The Foundation: RxC, Lash, McKesson, MedVantx, AZ Associates, GARA. 

Qualifications:

• Bachelor’s degree required (preferably in finance, business, or related discipline)
• MBA or Master’s in finance or economics degree

Required Skills and Experiences:

• Knowledge of the pharmaceutical/biotechnology or related industry
• Strong knowledge of business analysis and forecasting best practices, methodologies, and tools
• Knowledge of, or aptitude to learn, the issues and trends in healthcare reimbursement and the managed care environment
• High level of proficiency with Microsoft Project, Access, Excel, Visio, PowerPoint, and Word 
• Strong communication, presentation, leadership, and time management skills
• Strong business acumen needed for advanced analysis, modeling and tracking of quantitative and qualitative business data and metrics; and the ability to extrapolate and report strategic and operational insights
• Demonstrable project management skills: proven ability to manage multiple tasks to conclusion, on time, and without compromise to quality of work output
• Strong customer orientation/focus

Preferred Experience:

• 10+ years of experience in finance, auditing, and analytic roles managing large departments in progressive senior roles
• Experience in revenue forecasting, including trending and uncertainty analyses
• Experience in strategic consulting or other analytical work in the pharmaceutical or related industry

Competencies:

• Strategic Agility
• Business & Technical Expertise
• Lean Management
• Achieving Results
• Teamwork & Collaboration

As a Recruiter, 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 primarily support Genentech’s US Medical Affairs team, which is part of the overall Commercial, Medical and Government Affairs (CMG) organization. You will work with employees and managers in Medical Affairs to assure that we have the talent required to meet their business objectives.  You will foster a team environment and demonstrate collaborative leadership, and will partner with the Human Resource Managers and Talent Acquisition Management to develop and implement recruiting plans and strategies for Medical Affairs.

Additional responsibilities may include:

• 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 as needed, 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 as needed

• Contribute to the development of recruiting process improvements

• Utilize, update and maintain applicant tracking system (Workday)

• Develop advertising and social media strategies for specific groups and coordinate advertising activities with recruitment advertising agency

KEY COMPETENCIES

Teamwork and Collaboration

• Establishes strong collaborative relationships, among members of the Commercial Talent Acquisition Team, our HR partners, and Hiring Managers

• Addresses and resolves conflict by creating an atmosphere of openness and trust, and inspires others to do their best work by offering support and encouragement

Communication

• Listens well, expresses ideas fluently and eloquently, and is open to the input of others

• Can be depended on to tell the truth regardless of the circumstances

• Adjusts communication style and approach to work with a diverse set of hiring leaders and candidates

Achieving Results

• Is goal-directed, persistent; driven to achieve objectives, but doing so in a way that supports strong teamwork and collaboration

• Holds self accountable for meeting commitments, and recognizes the contributions of teammates and peers

JOB REQUIREMENTS

• 3+ years of recruiting experience and Bachelors degree required

• Prior experience in corporate recruiting in biotech or pharmaceutical industries is desirable

• Robust experience recruiting MDs is highly desirable

• Strong technical expertise in where to source appropriate candidates for Medical Affairs

• Demonstrated expertise in utilizing progressive sourcing options such as direct sourcing, web 2.0 recruitment tools, networking, college recruitment, diversity recruiting, leveraging employee referrals

• Strong assessment skills to evaluate candidates business and or technical background

• Knowledge of behavioral interviewing techniques

• Strong teamwork and collaboration skills are required as well as taking on additional responsibilities as needed

Strongly prefer candidates based in the San Francisco Bay Area, but open to remote workers with strong and relevant backgrounds for the role.

Please note this is a Night  Shift position, 6:00pm to 6:30am Sunday through Tuesday (every other Saturday)

Responsibilities:

• Adhere to all plant safety policies and procedures and proactively identify unsafe conditions Perform safety and housekeeping audits as required
• Assist in set up, change over, and test run equipment for various-sized vials and packages as required
• Supporting the Operations Specialist, Maintenance, and/or outside services in the repair, maintenance, and calibration of Genentech systems as required
• Perform training of other Technicians
• Assist in the development of plant SOP's and training materials
• Execute production recipes, check-in equipment, and perform material movements using automated computer software applications (SAP and MES systems)
• Operate all formulation, sterile filling, inspection, and final vial packaging equipment in the plant Perform material handling in the plant as required
• Perform preparation of sterile components
• Assist in the cleaning, set-up, sterilization, and dis-assembly on a variety of processing equipment Perform bulk thaw, dilution, and formulation operations
• Performing manual inspection of empty vials and filled product with a focus on quality and efficiency Conduct environmental monitoring activities in the manufacturing areas as required
• Prior to start-up, during processing, and at the completion of the manufacturing process, perform all documentation and clerical functions to provide the proper accountability and traceability of components and finished product
• At the start and finish of each shift, report and make recommendations regarding equipment, supplies, required repairs, process concerns, safety concerns, and areas for improvement in reliability, yield, and efficiency
• Work effectively and efficiently in a team-oriented environment to ensure maximum and high quality output Perform cleaning and housekeeping duties as required

Qualifications / Requirements:

• Proficiency in the English language - reading, writing, and communication
• Must be able to work all shifts (1st, 2nd, or 3rd), required overtime as needed, able to lift 45 pounds, and stand for extended periods of time
• In addition, all candidates must pass a vision acuity and color discrimination test
• Must complete periodic physical examinations to identify medical conditions which pose a risk to Grade C or higher operation
• Must have 1 to 2 years (within the last 7 years) experience in the operation of complex mechanical equipment used in the washing, filling, conveying, sealing, inspection and packaging of products/containers is highly desirable (target industries include pharmaceutical, biotechnology, biomedical, electronic, chemical, food, cosmetics, and/or other medical industries)
• Must be computer literate, including ability to interface with computer systems and PLC-based logic.
• Must be comfortable working with Microsoft suite (Word, Excel, PowerPoint), navigating through web pages and e-mail. Must possess basic typing skills

Roche is an equal opportunity employer.

The Associate Director in Protein Analytical Chemistry leads a group that drives completion of analytical activities in Genentech’s late stage portfolio, including molecular characterization, method development, assessment of comparability, and analytical support.

   
Key Responsibilities

Functional/Technical

• Develops continuously improving group strategy for our exciting late stage pipeline and ensures tasks are level loaded appropriately and transparently.
• Fosters group’s analytical development capabilities and business processes
• Provides technical advice and reviews project plans.
• Works closely with colleagues in process development, clinical/commercial quality, and regulatory to ensure project success.
• Reviews and approves test procedures, method validation protocols and reports, and health authority filings for stage programs.
• Mentors and cross-trains group members.

Member of Leadership Team

• Accountable as a leader on the Protein Analytical Chemistry team to resource clinical development and technology projects effectively across department.
• Manages and develops staff to produce a cohesive department that can nimbly and flexibly resource projects.
• Embodies lean principles and methods while fostering a mindset of quality, innovation and continuous improvement throughout the organization by encouraging experimentation and learning. Is an active and visible change agent, promoting flexible and open mindset to new opportunities. 
• Ensures the department complies with safety and GMP requirements
• Approves external submissions from the department.
• Provides scientific and technical analytical expertise at various forums and committees.   
• Actively engages in external influencing and industry best practice discussions to advance strategic priorities.

Qualifications

• PhD in Life Science, Analytical Chemistry, Immunology, Cell Biology or other relevant Life Sciences discipline.  Those with significant relevant experience without a PhD may also be considered.
• A minimum of 7 years relevant experience in the pharmaceutical or biopharmaceutical industry, with at least 5 years of managerial experience.
• Strong scientific background in analytical control strategy development and implementation.
• Extensive in-depth experience with global regulatory filings for clinical, launch, and commercially approved products across a broad range of product classes; e.g. therapeutic proteins, recombinant monoclonal antibodies, antibody drug conjugates.
• Strong experience in the assessment of technical data and scientific information is required in order to provide technical reviews for documents and regulatory submissions.
• Ability to manage and motivate groups and think creatively to find solutions to problems.
• Excellent understanding and technical proficiency with analytical control systems, critical quality attributes, characterization methods, and CMC development processes for recombinant proteins.
• In depth knowledge and experience in analytical chemistry across a wide range of technologies (HPLC, CE, MS, etc.) is highly desirable.
• A proven track record with authoring CMC sections.
• Demonstrated knowledge and execution of Quality Control operations and processes related to biopharmaceutical manufacturing.
• Highly competent in US, EU, Japan cGMPs and ICH requirements.
• Ability to identify and define clear problem statement and drive resolution through sound and systematic application of technical knowledge. Innovative and effective in solution development, risk management, and execution.

Genentech seeks a talented and highly motivated bioinformatics scientist to pursue translational research in collaboration with the Department of Oncology Biomarker Development. The successful candidate will get the opportunity to pair world-class science with human impact.

The primary focus will be on the translation of complex molecular biomarker data, derived from clinical trial samples, into useful diagnostic tools that can guide our understanding of drug activity in patient tumors, characterize mechanisms of acquired drug resistance, and identify subsets of patients who may benefit from specific therapeutic interventions. The candidate will undertake biomarker analysis efforts primarily for breast and gynecological cancers.

We are looking to add a new member to our team with outstanding computational skills, experience with the analysis of large-scale data, and an understanding of cancer biology. A successful candidate will work with interdisciplinary teams (including biomarker, clinical, research and biostatistics scientists), will pursue creative solutions to complex problems via the analysis, integration and interpretation of a variety of data, and apply (or develop) best-in-class methods that address the motivating biological and clinical questions. Regular publication of scientific or methodological results is strongly encouraged. Besides technical expertise, we are looking for someone who is passionate about applying their skills to advance our understanding and treatment of cancer, and who is able to effectively present complex results in a clear and concise manner that is accessible to a diverse audience of quantitative, experimental, and clinical scientists.

Who You Are

• You have a PhD in bioinformatics, biostatistics, computational biology or similar, with a strong publication record. Alternately, a PhD in molecular biology combined with a very strong record of high-throughput data analysis, supported by first- or corresponding author publication in this area. Postdoctoral experience is a plus.
• You have broad experience with data generated by high-throughput molecular assays, with a particular emphasis on next-generation sequencing technologies.
• You have an understanding of the statistical principles behind current best practices in the field, as well as experience with biomarker characterization and discovery.
• You are comfortable writing code in a high-level programming language such as R, MATLAB, Python or Perl for complex data analysis.
• You have a solid understanding of the relevant concepts in cancer biology, as well as enthusiasm for further learning.
• You have exceptionally strong communication, data presentation and visualization skills.
• You enjoy working closely with bench scientists and bioinformatics teams to collaboratively solve complex biological problems, and are able to handle several concurrent priorities in the context of a fast-paced project.

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The Position

We are seeking a highly motivated Scientist or Senior Scientist to join the OMNI-Biomarker Development Department within Development Sciences to drive our personalized healthcare efforts in multiple sclerosis. Our department is responsible for defining biomarker and personalized healthcare strategies, designing and implementing biomarker assays, and interpreting biomarker results. Our group uses relevant biomarkers to evaluate disease heterogeneity, target-engagement, mechanism of action, and disease modification, and to guide clinical diagnostic biomarker development. Biomarker team leaders within the department provide scientific leadership for biomarkers in clinical trials ranging from early proof-of-concept through marketed products.

Responsibilities:

The successful candidate will join our dynamic team and work to identify and assess personalized healthcare strategies in multiple sclerosis.  The candidate will support our multiple sclerosis biomarker strategy, leading efforts for data analyses of internal studies and external collaborations relating to understanding clinical aspects of multiple sclerosis through genetic and other biomarker data across clinical data sets, with the opportunity for the successful Scientist to grow into a project biomarker representative/team leader. Success in these responsibilities requires a thorough understanding of disease and drug target biology, creativity and attention to detail, and experience in integrating biomarkers into clinical trials. Candidates familiar with molecular and immunological techniques including immunoassay, qPCR, whole genome sequencing methods and/or genetic analysis algorithms will be given preference. The position requires working in close partnerships across various functions including Research, Bioanalytical Assays, Diagnostics, Clinical Sciences, Biostatistics, Bioinformatics, Regulatory and with external partners. Effective communication is essential and includes presentations at cross-functional teams, internal review committees, and external conferences, and will also involve writing biomarker sections of clinical protocols, reports, regulatory filings and scientific publications.

Who You Are

Candidates must have a PhD or MD in Neurology, Neuroscience and/or Immunology, or a related field with at least 3 to 5 years of post-doctoral or fellowship experience in basic or translational research either in an academic and/or industry setting. The candidate must demonstrate a high level of independence and be able to develop hypotheses and direct analysis plans. Strong writing and communication skills are required, as evidenced by publications, meeting abstracts and/or drug development reports. We are looking for an individual who would be passionate about using their understanding of disease biology to make impactful contributions to clinical drug development. Willingness to collaborate across time zones including our Swiss site is a must.  Preferred candidates will have prior experience in multiple sclerosis and a demonstrated ability to function as part of a cross-functional team such as clinical trial project teams.

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The candidate will be part of Direct Procurement Pharma (DPP), a strategic unit supporting the entire organization including manufacturing, process development and research. Together with our Business Partners we will ensure best value and uninterrupted and compliant supply of materials and services from our suppliers to meet current and future business requirements. The project will be focused on Single Use Technology a category of direct material used in Manufacturing production under the supervision of the global category manager within TOP- Direct Material.

Project Overview

This role will provide an opportunity to join Global Procurement and contribute for a whole year to an exciting and fast growing category of direct materials at Roche; Single Use Technology (SUT). With this project, the analyst will be exposed to the core of category management; the ability to source, manage, and assure supply with the right level of quality and a solid risk management program.

1) Essential to enable a robust supply chain to the GMP network, the analyst will perform a portfolio analysis, through which he/she will develop a solid understanding of where and how SUT materials are used across the DS network and the risk that each material carries. The candidate will need to work well participating in and leading cross functional teams, often globally with stakeholders both internally across PT and externally with Roche key suppliers.

2) In support of single use implementation, the candidate will participate in the development of a standard catalog to drive standardization within the network and support the sourcing of future single use technology.

3) The candidate will participate and assist the global category manager in category management activities, supplier relationship management and sourcing activities. This will include activities like updating databases, refreshing global guide and updating website content as well as participating in executive meeting and managing agenda, minutes and action items.

Qualifications

• BS/ MS with technical background in bioprocessing (Experience with SUT preferred)
• Strong communication, collaboration, and project management skills
• Ability to operate and execute effectively in a dynamic, fast-paced environment with multiple priorities and challenging deadlines.
• Process-oriented with strong analytical skills, strategic thinking, and creative problem solving capabilities
• Excellent written and verbal communication, influencing and persuasion skills
• Demonstrates a sense of urgency and proactive approach that is results focused

Additional Comments

This position will require strategic thinking, project management, collaboration, communication, some technical/operational skills, influencing abilities, and data management skills.

The Supply Chain Organization connects the different parts of Roche to ensure reliable supply of our innovative medicines to customers and patients. We ensure worldwide reliable supply to patients connecting their needs to the Roche Pharma Global Supply Network. This network consists of Roche manufacturing sites, contract manufacturers and external suppliers. We partner across Pharma to develop and execute agile product lifecycle and network strategies and we design and optimize end-to-end Supply Chains from raw materials to final product throughout the whole product life-cycle.

The intern will model mathematically a multivariate supply planning process, analyze historical data, and apply novel stochastic optimization tools to determine optimum supply plans under uncertainty.QualificationsPreferred degrees Master's level or Ph.D level. Expert in Systems Engineering and Stochastic Optimization.

Reputation and Issues Management Lead APAC / Senior Communications Manager

Reporting to the Global Head of Reputation and Issues Management, the Reputation and Issues Management Lead APAC is responsible for shaping both the external environment and Roche’s reputation in order to build a competitive edge and further the company’s business strategy.

S/he is the trusted advisor of the Global Head of Reputation and Issues Management and other senior leaders, and will set, define and oversee the implementation of the overall strategy, objectives and goals for the function in APAC.

S/he is the primary communications contact for APAC, acting as an enabler of the new more networked communications model and providing strategic counsel to the Heads of Corporate Affairs and their respective leadership teams where needed. In this capacity s/he is responsible for ensuring team members maintain a high level of engagement and performance.

S/he is expected to play a leadership role at the global level and will be required to build and lead at least one global community of practice (e.g. Crisis Management, Insight and Reputation Strategy, or a key business topic etc), both enabling and guiding the development of cross-country solutions to find common opportunities and mitigate challenges.

S/he will take the lead on establishing and maintaining issue preparedness - as well as issues management - activities in APAC. In doing so s/he will establish robust governance practices, provide training to leadership teams, identify risks and will subsequently lead cross functional teams through the development and implementation of issues management strategies which tackle business critical topics or key challenges.

The position can be located in any country in the corresponding area.

In this position, you will be primarily accountable for:

• Acting as an enabler and connector for the communications network; fostering fit-for-purpose/ high impact programmes and partnerships, driving the advancement of the function and career development for communicators, and ensuring the APAC  Corporate Affairs teams meet or exceed assigned goals and objectives.
• Taking the lead on resolving business-critical topics or issues/crises which impact (positively or negatively) our reputation either in [insert area] or globally, partnering with key (internal & external) stakeholders to do so.
• Establishing and maintaining robust issues management systems and practices within APAC; establishing robust governance practices, provide training to leadership teams, identify risks and leading cross functional teams through the development and implementation of issues management strategies which tackle business critical topics or key challenges.
• Leading at least one global Community of Practice focused on either a specific dimension of Public Affairs or a critical business topic, enabling the creation of community driven approach with high impact results.

Requirements:

• Bachelor degree, preferably in International Relations, Politics or relevant certification, relevant Graduate-level degree (e.g., Public Policy, Public Relations, International Development) is a plus.
• Several (10+) years of experience and good knowledge of the pharmaceutical, biotechnology or related industry, robust understanding of the geopolitical outlook and the key stakeholders and the associated affiliates. Political / Public Affairs knowledge and intimate knowledge/understanding of key policy trends and their business impact essential.
• Experience leading on above country, multi-stakeholder engagement & advocacy, proven leadership experience in a non-hierarchical environment.
• Strong consulting and leadership skills.
• Extensive issues and crisis management experience (mitigation and response).

Associate Director, HR Business Partner, PT (Hillsboro)

In PTG we are working as one integrated Drug Product manufacturing network – across Basel, Clarecastle, Hillsboro, Kaiseraugst, Mannheim, Rio de Janeiro, South San Francisco, Shanghai, and our DP external manufacturing network – to provide a variety of medicines to more patients around the world.

Our mission is clear: across our network and together with our Roche colleagues, we need to work together each day to reliably deliver our pipeline and ensure uninterrupted supply of quality products everywhere and in all forms.

In this role you will lead an HR Organization and you will be accountable to develop and drive business strategy and ensure organizational effectiveness by applying broad functional knowledge, skills and solid judgment and influence the overall objectives and long range goals of the Hillsboro campus. 

You will be a member of two client facing leadership teams, Hillsboro Drug Product Manufacturing and PCV Manufacturing leadership teams and accountable to deliver strategic business results, drive employee strategies that will have a deep impact across the PTG network.

This person will possess a full range of proficiency and experience in the following areas of: Workforce Planning, Recruitment, Performance Management, Compensation, Organizational Development, Coaching/Consultation, Talent Management, Succession Planning, Change Management, Project/Program Management and leadership for a team of direct reports.

The AD will apply strong technical expertise, knowledge of the business and environment, and situation specific analysis to develop and implement new concepts, techniques, and standards to address organizational and people-related challenges across the Hillsboro Campus. 

Primary Responsibilities:

• The AD will act as coach and business partner to the two VPs located at the Hillsboro campus, and to the two leadership teams
• As a key member of the Hillsboro campus Leadership Teams, the AD will be able to influence and collaborate with colleagues to create, continuously evaluate and ensure strategic Human Resources support aligned with business objectives and consistent with PT and company values and culture, and in compliance with laws and regulations.
• The AD will understand how various organizational dynamics may affect the overall performance of the business and will be able to manage dynamics between the two sites making sure they are both successful with their own business goals
• The AD will provide consultation to the organization on strategic projects and goals as they relate to the effectiveness of the Hillsboro campus influencing cross-functional business activities/initiatives where appropriate.
• The AD will successfully plan, prioritize, and lead complex work assignments.
• The AD will be accountable for creating people strategies and assigning resources across the organization ensuring coordination, prioritization and deployment of integrated solutions to support the site’s objectives and goals.
• The AD will build, lead and manage a high-trust, highly-aligned team of Human Resource
• The AD will manage with clear goals and priorities that will support the site’s business needs.
• The AD will determine most efficient and effective way to deliver services considering costs, ratios and appropriate Key Performance Indicators, partnering with service
  organizations where possible.

Qualifications and Experience:

You are a solid coach and creative problem solver able to analyze strategic choices and business opportunities and you bring the following qualification:

• 10+ years of progressively responsible HR and/or business experience with a minimum of 7 years of HR or related experience and exposure to and competence in HR functional areas and 5+ years experience managing people or teams 
• Bachelor’s Degree or equivalent work experience required, Master’s or MBA preferred
• Comfortable engaging executives and developing personal relationships with clients and able to naturally empathize with their needs
• Strong analytical and communication skills
• Ability to lead projects and manage client engagement activities, results driven with the ability to manage tasks through completion
• Prior experience managing a team of professionals
• Proven track record for consistently meeting or exceeding quantitative goals
• Bio-tech or pharmaceutical experience a plus
• Broad HR background
• Experience managing teams in matrix environment

The CDx PL/Sr. CDx PL will guide the strategy and implementation of companion diagnostics in support of projects within Genentech’s extensive Early and Late Development portfolios. The CDx PL/Sr. CDx PL will play a critical role in enabling personalized healthcare for Roche/Genentech therapeutic programs.

The CDx Project Leader will be responsible for the following:

• Lead the companion diagnostic strategy on the biomarker teams within Genentech Research and Early Development (gRED) and Product Development (PD) therapeutic programs and ensure alignment of companion diagnostic development milestones with clinical milestones and overall biomarker strategy.
• Manage multiple CDx development partnerships and serve as the single point of contact to diagnostic partner to execute on jointly defined deliverables, from assay development kick-off to diagnostic launch
• Efficiently manage multiple companion diagnostic development projects and provide timely updates to relevant functional teams regarding development status
• Provide technical expertise and work closely with biomarker leaders, sample operations, clinical science and regulatory representatives on the successful implementation of companion diagnostic assays in clinical trials
• Collaborate with clinical operations and sample management to ensure optimal biomarker testing and diagnostic data collection in clinical trials
• Develop and lead IVD strategies that are aligned with disease areas, including primary and follow-on CDx, and support initiatives on broad access to CDx testing
• Lead the development of singleplex assays and multiplex platforms, including novel technologies, to support investigational and approved products in collaboration with diagnostic partners

Who You Are

The ideal candidate for the CDx Project Leader/Sr. CDx Project Leader will meet the following qualifications:

Qualifications

• Ph.D (preferred) in a Life Science or equivalent. M.S. degree will be considered for exceptional candidates.
• Broad knowledge and understanding of established and novel assay technologies (e.g., IHC, digital pathology, PCR, NGS, liquid biopsy, imaging).
• Understanding and experience in the drug development process (clinical trials, efficacy endpoints, biomarker testing)
• Understanding of IVD technologies and IVD development process is preferred
• Must be detail-oriented with strong project management and organizational skills in order to manage multiple projects and meet assigned deliverables
• Strategic agility and ability to adapt to the evolving personalized healthcare environment
• Ability to work well on teams and keep relevant stakeholders informed regarding status of programs
• Strong written and verbal communication skills and ability to effectively communicate with cross-functional teams

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The Digital Transformation Leader will be responsible for setting the strategic vision for digital enhancements in clinical supply, will oversee a portfolio of digital capabilities and may lead various projects to roll out new digital capabilities.  The incumbent will act as the liaison between Clinical Operations and the Clinical Supply organization related to digital offerings by Clinical Supply across the clinical trial space.  He/she will lead assessments of new technologies and as appropriate will lead the roll out of new capabilities.  The successful candidate will be responsible for leading transformation that contributes significantly to the goals and objectives of PTD(S).

Job Responsibilities

• Serve as primary consultant for senior management and as the internal/external spokesperson for PTDS related to digital capabilities and options available in the clinical setting.
• Influence the development of objectives and long-range goals related to the application of technologies to enhance clinical trial design, speed, adherence, and effectiveness for Roche / Genentech.
• Manage a portfolio of digital capabilities and systematically prioritize the opportunities
• Establish a digital transformation strategy working directly with the Clinical Trial Supply Leadership team that leverages cutting edge capabilities available through Industry 4.0; these options may span packaging design, push and pull of information to smart devices, the latest in chip technologies, software, and hardware offerings.
• Partner and collaborate globally with leaders in Clinical Operations from gRED, pRED, and PDG to identify areas where digital options could significantly add value to trial design and execution.
• Identify unique digital capabilities and platforms that can enhance and augment clinical trials to address current challenges; identify necessary “building blocks” (eg. Master Data, Process Framework, People Capabilities) for the organization to be put in place
• Lead cost/benefit analysis assessments for various technology options.
• Identify, select, and partner with external suppliers and contract manufacturers to enhance Roche’s digital capabilities in the clinical space; lead projects to bring these capabilities on board.
• Develop framework for effectively identifying trial candidates and matching clinical trials to appropriate technology options.

Job Requirements

• Bachelor's degree with 12+ years of relevant experience in the pharmaceutical, IT or related industry; 10+ years of experience with a Master's degree
• Possess strong analytical skills and strong skills/experience in decision analysis tools and methods
• Experience setting strategic direction within organizations
• Full use and application of Supply Chain/Business Process/cGMP theories, principles, and systems
• Ability to effectively interpret Quality Standards as they relate to various technology options
• Ability to manage projects from initiation to delivery
• Ability to independently set work objectives and priorities without direction; proven ability to succeed when given significant latitude in determining objectives and approaches to assignments.
• Possess a strong understanding of available digital capabilities and platforms within the clinical trial setting
• Ability to communicate clearly and professionally both in writing and verbally
• Significant experience in Clinical Supply Chain and/or Clinical Operations
• Demonstrated project leadership and management skills

Preferences

• Experience in GMP Biopharmaceutical production facility
• Experience managing significant IT implementation projects
• APICS CPIM certification and/or Project Management Professional certification

The Position / Responsibilities

We are seeking a highly motivated individual for a Scientific Researcher/Senior Scientific Researcher position in Drug Metabolism and Pharmacokinetics (DMPK) department at Genentech. In the Drug Permeability/Transport lab researchers investigate the cellular permeability of novel small molecules, in particular peptides, and the roles of membrane transporters in the disposition of these drug candidates.

Key responsibilities for this position include hands-on experimentation using cell biology and biochemical techniques to characterize the interactions of peptides (<3000 Da) with cell membranes and drug transporters, thereby elucidating the mechanisms affecting in vivo and cellular permeability/transport and providing project teams with relevant information for the optimization and identification of lead compounds. These data will also be used to explain or enhance the cellular pharmacological response. The qualified candidate must be able to work in a team environment, collaborate with multidisciplinary researchers on various aspects of projects, and meet timelines efficiently and productively.

Requirements

Qualified candidates will possess the following skills and experience.

• Bachelor’s degree in biological sciences, bioengineering, pharmaceutical sciences, or related discipline; candidates with a Master’s degree are encouraged to apply. Academic or industrial laboratory experience with ADME characterization of peptides (< 5 years) is desirable.

• Technical background in membrane biology, biochemical and cell-based assays and peptide analysis (LC/MS) are highly desirable.

• Understanding of peptide chemistry, stability and ADME are essential.

• Tissue culture proficiency is required. Primary cell culture proficiency is preferred.

• Proven ability to independently design, execute, and interpret experiments.

• Flexibility to manage multiple projects simultaneously and advance research independently as well as being part of highly collaborative team is essential.

• Scientific curiosity and strong work ethic, excellent critical thinking and verbal/written communication skills.

Drug Metabolism and Pharmacokinetics (DMPK)
The DMPK department is dedicated to enabling the discovery, development and commercialization of safe and effective medicines by elucidating the absorption, distribution, metabolism, excretion and pharmacokinetic properties of small molecule drug candidates. We accomplish this through the application of state of the art technologies and sciences of bioanalysis, drug metabolism, drug transport and pharmacokinetics. The DMPK group works in close partnership with disciplines such as medicinal chemistry, pharmacology, toxicology, pharmaceutical sciences, clinical pharmacology and regulatory to optimize leads, select clinical candidates, conduct preclinical development studies, support clinical evaluation and contribute to IND and NDA filings.

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The DMPK biotransformation group at Genentech is seeking a highly motivated individual to support development drug metabolism. Primary responsibilities include:

• Hands-on LC/MS experience and proven abilities in determining the biotransformation pathways of drugs by drug metabolizing enzymes.
• Profiling and identifying drug metabolites in in vitro and in vivo biological matrices using HPLC with radiometric detection and LC-MS/MS
• Designing, executing and reporting biotransformation studies to support drug development and regulatory filings.

Requirements

The level of the position is Senior Scientific Researcher (SSR).  Qualified candidates will meet the following requirements:

• BS/MS degree in chemistry, biochemistry, pharmaceutical sciences or other relevant discipline
• Hands-on experience with LC-MS and/or drug metabolism; 5+ years of experience in both LC-MS and drug metabolism with expertise in sample preparation and analysis, including metabolite structure elucidation by MS/MS.  Experience using radiolabels, conducting regulatory filing studies, and writing scientific reports preferred
• Capable of working independently.  Good writing and verbal communication skills.

The Drug Metabolism and Pharmacokinetics (DMPK) group at Genentech is dedicated to enabling the discovery, development and commercialization of safe and effective medicines by elucidating the absorption, distribution, metabolism, excretion and pharmacokinetic properties of small molecule drug candidates. We accomplish this through the application of state-of-the-art technologies and sciences of bioanalysis, drug metabolism, drug transport and pharmacokinetics. The DMPK group works in close partnership with disciplines such as medicinal chemistry, pharmacology, toxicology, pharmaceutical sciences, clinical pharmacology and regulatory to optimize leads, select clinical candidates, conduct preclinical development studies, support clinical evaluation and contribute to IND and NDA filings.

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The Drug Metabolism and Pharmacokinetics (DMPK) group at Genentech is dedicated to enabling the discovery, development and commercialization of safe and effective medicines by elucidating the absorption, distribution, metabolism, excretion and pharmacokinetic properties of small molecule drug candidates. We accomplish this through the application of state of the art technologies and sciences of bioanalysis, drug metabolism, drug transport and pharmacokinetics. The DMPK group works in close partnership with disciplines such as medicinal chemistry, pharmacology, toxicology, pharmaceutical sciences, clinical pharmacology and regulatory to optimize leads, select clinical candidates, conduct preclinical development studies, support clinical evaluation and contribute to IND and NDA filings.

The DMPK group is seeking a highly motivated individual to apply drug metabolism in drug design. Primary responsibilities include:

• Hands on work in metabolite identification by LC-MS/MS and determine the biotransformation pathways of small molecules and peptides
• Solid understanding of drug metabolizing enzymes and applications of in silico tools in drug metabolism
• Design, perform and interpret drug metabolism studies with focus on characterizing metabolism pathways and soft-spots in drug discovery
• Integrate metabolism information into guiding chemistry designs

Requirements

 The level of the position (Associate Scientist or Scientist) will depend on the qualifications of the selected candidate. 

Qualified candidates will meet the following requirements:

• Ph.D. degree in organic chemistry, medicinal chemistry, pharmaceutical sciences or other relevant discipline with a strong chemistry and experimental metabolism background
• 2+ years of experience in the pharmaceutical industry or post-doc in a similar role is preferred; previous experience working with medicinal chemists to guide drug design is desirable
• Record of accomplishment as evidenced by co-authored publications in scientific journals; first-author publications are required at the Scientist level
• Working knowledge of drug metabolizing enzymes, bioactivation and bioanalytical techniques such as chromatographic separation and LC-MS/MS
• Ability to work independently and as part of a team, along with excellent communication skills
• Proven track record of project leadership is a plus

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We are seeking an exceptional individual for an Associate Scientist/Scientist position in Drug Metabolism and Pharmacokinetics (DMPK) department at Genentech. This position will support our continued efforts to apply physiologically based pharmacokinetic (PBPK) modeling to support discovery and development projects. Meanwhile, the individual will also expected to represent DMPK function in a project setting.

Requirements: A PhD degree specializing in pharmacokinetics and/or drug metabolism or other relevant fields. A strong understanding of PK and ADME concepts, and practical experience in in vitro and in vivo extrapolation in at least one of the following areas: absorption, distribution, enzyme metabolism, transporter and excretion. Hands-on experience in PBPK modelling (eg. Simcyp, Gastroplus or customized models).

Desirable: Good organizational, collaboration, communication skills and flexibility are important assets. 0 – 4 year previous DMPK pharmaceutical industry experience. Familiarity with PK/PD basic methodology and relevant modeling and simulation tools (e.g. WinNonlin, ADAPT, SAAMII ).

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The DMPK department is dedicated to enabling the discovery, development and commercialization of safe and effective medicines by elucidating the mechanisms of absorption, distribution, metabolism, and excretion of small molecule drug candidates. We accomplish our goals through the application of state-of-the-art technologies for bioanalysis, drug metabolism, drug transport and pharmacokinetics. The DMPK department works in close partnership with disciplines such as medicinal chemistry, in vivo pharmacology, toxicology, pharmaceutical sciences, clinical pharmacology and regulatory to optimize lead compounds, select clinical candidates, conduct preclinical studies, support clinical development and contribute to IND and NDA filings.

Job Description

The DMPK-BA function is primarily responsible for overseeing regulated bioanalytical activities conducted at contract research laboratories (CROs), and ensuring overall compliance with GLP/GCP regulations to support the preclinical and clinical development of Genentech’s small molecule programs. Responsibilities include, but are not limited to: technical monitoring during bioanalytical method development, validation, and sample analysis; overseeing method transfer between CROs; reviewing validation reports and experimental documentation; and archiving relevant study documents. The individuals in this function also conduct CRO evaluation and selection, review CRO SOPs, determine additional bioanalytical requirements if needed, and perform regular site visits and inspection.

Internally, the individuals are responsible for developing highly sensitive and specific bioanalytical methods for quantitative analysis of new chemical entities, metabolites, and biomarkers in a variety of biological matrices, reproducing CRO-developed methods, and performing non-regulated quantitative bioanalysis. The individuals serve as bioanalytical representatives on inter-disciplinary project teams. In addition, the individuals may supervise and train junior staff to successfully perform all the above-mentioned responsibilities. 

The ideal candidate for the DMPK-BA Associate Scientist position typically has a doctoral degree in analytical chemistry, biochemistry, or equivalent with relevant industry experience of 1 to 3 years. The candidate needs to possess a demonstrated ability to work independently in a fast-paced environment, as well as in a team setting. The candidate should have in-depth bioanalytical knowledge and extensive experience with modern analytical instrument platforms, particularly with LC-MS/MS. The candidate is expected to have hands-on experience in developing and validating LC-MS bioanalytical methods using various techniques (SLE, LLE, SPE, and PP), and have strong multi-tasking ability to manage multiple studies simultaneously and be able to assist in troubleshooting when instrument or assay problems arise. The candidate should have a good understanding of GLP/GCP regulations, and possess excellent oral and written communication skills. Prior working experience at or with CROs is preferred.

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The Drug Metabolism and Pharmacokinetics (DMPK) department at Genentech is seeking a highly motivated individual who will be involved in the in vitro to in vivo translation of data in the non-clinical space.   This position will support our continued efforts to address gaps in in vitro – in vivo correlation and extrapolation (IVIVC and IVIVE).   A significant portion (? 50 %) of the time of this position is expected to be spent hands-on in the lab.  The expectation is that the individual will be involved in:

• Design and execution of in vitro studies
• Collaboration with scientists within and outside DMPK to support projects
• DMPK data analysis and modeling
• Model building

Requirements:  A PhD degree specializing in pharmacokinetics and/or drug metabolism or other relevant fields.  Direct experience with common in vitro ADME systems. A strong understanding of in vitro and in vivo DMPK principles.

Desirable Good organizational, collaboration, communication skills and flexibility are important assets.  0 – 4 years previous pharmaceutical industry experience with experience in drug discovery and candidate selection. Familiarity with PK/PD and PBPK basic methodology and principles. Familiarity with commonly encountered modeling and simulation packages (e.g. WinNonlin, Simcyp, Gastroplus, ADAPT, SAAMII ).  In addition, familiarity with software packages such as MATLAB, SIMBIOLOGY, Python, R or other similar programs is highly desirable.

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We are seeking an exceptional individual for an Associate Scientist position within the small molecule bioanalytical group of DMPK Department at Genentech. The successful candidate will have strong background in Bioanalytical Mass spectrometry (LC-MS/MS and LC-HRMS) with hands on experience and proven ability to independently design, develop and routinely employ bioanalytical methods for the quantitative and qualitative analysis of endogenous small molecule metabolites (biomarkers), new chemical entities and their metabolites in various biological matrices. Candidates should also have a very good understanding of various small molecule metabolomics workflows, instrumentation and experiment design. This role also requires a good understanding of preclinical and clinical ADME, endogenous metabolic pathways to work collaboratively with teams from research to drug discovery and development. The candidate will work as a member of the metabolomics/bioanalytical group and will be responsible for method development, sample preparation (LLE, SPE, and PP) and data acquisition on various platforms such as QTRAPs, triple-quadrupole instruments, high-resolution mass spectrometers (QTOF, Orbitrap QE series), and data processing using Xcalibur, Compound Discoverer, Tracefinder, Analyst/Multiquant, and XCMS+. The candidate should be able to assist in troubleshooting when instrument or assay problems arise. Other responsibilities will include metabolomics data visualization and statistical analysis, electronic laboratory notebook keeping and communication of results to project teams.

Requirements: Ideal candidate is preferred to have a PhD in chemistry, biochemistry, or other equivalent degree with relevant experience of 0-2 years. Experience with metabolomics workflows is preferred. Candidate should also possess excellent oral and written communication skills.

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Considering local candidates only. 

The Global Project Manager (GPM) is a core member on the Lifecycle Team that sets strategy and delivers transformative medicines to patients faster and more effectively. The GPM is a strategic partner with their team leaders and plays a critical role in proactive planning, execution and optimizing timelines/resources through excellence in project management.

Responsibilities:

• Support complex molecule teams or strategic teams with high portfolio impact and value.
• Drive project and portfolio success by having an enterprise and portfolio mindset, being agile and managing ambiguity.
• Enable senior stakeholders (Lifecycle Leaders, Disease/Franchise Heads, Therapeutic Area Heads and Late Stage Portfolio Committee) to make effective decisions.
• Partner effectively with peers and senior stakeholders.
• Play a pivotal communication role in ensuring awareness and alignment of project decisions and updates across the Lifecycle Team and senior leadership.
• Transform insights into ideas and identify opportunities to accelerate project execution.
• Proactively connect, align and guide teams on key decisions and execution.
• Prioritize and focus team and individual efforts.
• Deliver consistent and high quality project management services to enable team and project success by being strategic in project planning, team management and process management.

• Lead functional initiatives or represent the department effectively on cross-functional teams, as needed, to contribute to the broader organization.
• Generate ideas and proactively contribute to a teach-and-learn culture to support the success of others and the department.
• Serve as a role model within the department and as an ambassador for the department across the organization.
• May manage 1-2 GPMs.

Reporting Line:

This position reports directly into a Group Leader/Associate Director in the PPS-PM group.  

Qualifications:

Successful candidates will have a minimum of 10 years of relevant experience, including a minimum of 7 years supporting cross-functional teams in a scientific environment required.  They can anticipate the needs of the project/business and proactively drive teams with portfolio context in mind. They have the ability to operate effectively in situations of ambiguity and guide teams through challenges, simplifying/distilling complex issues and influencing change in a skillful and mindful way.

• Project management and/or leadership experience supporting/leading cross-functional teams in a scientific environment.
• Drug development experience in the pharma/biotech industry.
• Strategic and analytical thinking skills to assimilate complex information to inform decisions.
• Leadership and influencing skills to be effective in a highly matrixed organization with geographically dispersed teams.
• Effective use of interpersonal skills and influence to drive optimal team performance.
• Display of leadership competency, executive presence and emotional intelligence.
• Strong contributions to functional and/or cross-functional initiatives.
• Ability to mentor others and serve as an ambassador for the department.
• Excellent written and verbal English communication skills.
• Travel internationally (up to 2-3 times per year).

Education:

Bachelor's degree required; advanced degree preferred.

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