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Date Job Title Job Level Location
12/13/17 Finance Manager -HTO Individual Contributor Hillsboro, Oregon

The Finance Analyst/Manager HTO Finance will provide strategic decision support to business partners as an active and engaged member of manufacturing leadership teams. The position will be located in Hillsboro OR and will report to the Head of Finance HTO, supporting Quality and Technical Operations (PT) leaders at the site. In addition to financial forecasting, planning and reporting activities, the successful candidate will leverage their system and process skills to help bridge the gap between the business, processes and data. They will be seen by his/her business partners as a thought leader in manufacturing who provides thoughtful business/financial advice and a partner in transforming business needs into systemic solutions.
Job Responsibilities:
  • Acts as an internal consultant by providing financial consultation and decision-support to business partners as needed; supports business in understanding state of finances and tactical / corrective actions required to achieve objectives
  • Monitor process and data effectiveness and efficiency against long term goals and objectives, propose corrective action as necessary; proactively identify, implement, and drive continuous process improvement, simplification and change
  • Work closely with customers and stakeholders to turn data into critical information and knowledge. Conduct financial data mining and value-based business analysis to influence / drive business decisions.
  • Interact and collaborate effectively within workgroups and areas of expertise; participate effectively on cross-functional teams, offer views and actively solicit ideas form others in seeking business solutions; encourage others in fostering effective teamwork; demonstrate strong customer service orientation
  • Performs financial analysis and develops business models for product, value, risk, market and cost assessments; uses analysis and models to provide and influence tactical and strategic decisions
     
     
  • Responsible for complete, accurate & timely monthly accounting & reporting; reviews product costing data in SAP to ensure transactions are executed accordingly to established standards
  • Ensures compliance with financial policies and recommend and/or take action as needed
    Competencies:
  • Interacts and collaborates effectively within workgroups and areas of expertise; participates effectively on cross-functional teams, offers views and actively solicits ideas form others in seeking business solutions; encourages others in fostering effective teamwork; demonstrates strong customer service orientation
  • Gets points across clearly, with straightforward language, both verbally and in writing, considers the needs and interests of others and incorporates information relevant to them in communications;
12/13/17 Sr. Finance Manager, Global Alliance Controller Individual Contributor South San Francisco, California

The main focus of this position is to manage several of Genentech’s profit-share collaborations with our alliance partners. Beyond the core responsibilities of high-quality forecasting, monthly closes and quarterly settlement payments, this role requires (1) proactive interaction with both internal and external management committees to help influence good decision making; (2) assertive and professional representation of Genentech’s interests in our alliances through robust financial analysis and effective communication, influencing and negotiation skills; and (3) establishing collaborative working relationships with our partners.

Key Responsibilities include:
  • Lead the financial management of several of our profit share collaborations with our alliance partners. This includes: 
    • Compiling, consolidating and reporting of financial information; ensuring accuracy of actual payments and receipts; performing a robust forecasting process; and clearly communicating the latest expectations to our various business partners.
    • Ensuring, in partnership with Roche Partnering and Legal, that we properly develop, maintain and track our understanding of the key contractual terms for several of our alliances, thereby ensuring compliance and proper stewardship. 
  • Serve as the Company’s financial liaison to various external partners (e.g., joint management committees with our external collaboration partners), as well as many internal business partners, both locally and globally (e.g., Finance, Roche Partnering, Commercial Franchise Management, Global Product Development, Legal, etc.)
  • Lead all interactions with external and internal auditors, supporting their requests for information and proving the robustness of the internal controls within our processes. This also includes initiating and overseeing audits of our partners’ books.
This position is not eligible for relocation.
12/13/17 Chemistry, Manufacturing & Controls (CMC) Senior Project Manager Individual Contributor South San Francisco, California

Location: South San Francisco


PTD Project and Portfolio Management (PTDMM) Department

 

PTDMMsupports the Technical Development Team systems and governance bodies (LSTDC,ESTDC, etc.) for CMC project and portfolio decision-making and delivery of theCMC pipeline by providing project management expertise and portfolioinformation and insight.

 

ProjectManager / Senior Project Manager Job Description 


We are seeking a Project Manager/ Senior Project Manager who will manage CMC projectteams to successful and timely decision points from Late Stage Research (priorto FIH) through approval (NDA, BLA, MAA). The Project Manager/Senior ProjectManager will
partner with a CMC Technical Development Leader(TDL) to help teams successfully define their CMC project strategy and deliveron project objectives. As a member of the PTDM-M department, they will also have theopportunity to project manage cross-functional initiatives across the PTDgroup. This position requires excellent communication,collaboration, negotiating, influencing and strategic thinking.

 

Additionalresponsibilities include but are not limited to the following:

 

·      Serve as strategic and technical partner to CMC Technical DevelopmentLeader (TDL), helping to drive CMC strategy in alignment with development teamgoals and technical functions on 3 – 5 CMC teams

·      Ensure teams achieve and maintain a high-level of sustainableperformance, by directly contributing or leading appropriate team managementbest practices

·     Facilitate and manage project teams and monitoring of critical pathand team activities, including documentingmeetings, decisions, risks and actions; cross-functional communication; and trackingof technical deliverables

·      Establish and maintainCMC aspects of functionally integrated project schedules to enable accurateproject, financial and portfolio analyses, and ensure accurate inputs areprovided into business planning processes

·      Apply drug development knowledge to different technical platformssuch as large molecule, device, small molecule, version change and/or antibodydrug conjugate in either the gRED, late stage or post market phases, in order to drive CMC teams to informeddecision making, and optimal alignment of all technical deliverables within theProject Team System

·     Proactively communicateissues and concerns providing transparency with key customers and stakeholdersin a global setting; act as a primary CMC contact formultiple functional areas across project teams

·      Provide timely presentations to Senior Management meetings andinformation for reporting such as the annual budgeting process, appropriategovernance committees, and monthly reporting

·     Drive business and corporate processes for CMC team, includingrisk assessment, governance and goal-setting

·     Oversee CMC team budget, including resources and costs, collaboratingwith team members, cross-functional department resource planners anddevelopment team Project Managers

o   Identify, recommend andimplement opportunities for streamlining team and business processes, serving as advocate and role model for integrating change intoorganization

o   As a member of the Global PTDM organization participate in staffmeetings, global TDL/PM forums and department initiatives

 


 

12/13/17 Global Royalty Controller Individual Contributor South San Francisco, California

As Global Royalty Controller you will be responsible for managing Genentech’s global royalty revenues (currently over $1B+ annually) and global royalty obligations (currently $500M annually). In this position you will also serve as a financial liaison to our external licensing partners, as well as many internal business partners, both locally and globally, in managing royalty related matters.
 
Key Responsibilities:

  • Manage the day-to-day royalty operations, including monthly local close activities for Genentech, Nutley and Palo Alto and serve as an effective back-up for the Head of Royalty Controlling, South San Francisco
  • Perform a robust royalty forecasting process (including budget setting, monthly outlooks and long range business planning), including analyzing and tracking latest upside/downside expectations
  • Monitor and ensure that we receive the appropriate amount of royalty revenues from our partners, through robust analytical review of partners sales and royalty report as well as partners investor updates and corresponding analyst expectations
  • Review, calculate and process accurate royalty payments, including analyzing and understanding affiliates / regional sales trends and the corresponding gross to net sales development
  • Work in close collaboration with Legal and Alliance Management to develop, maintain and track our understanding of the key terms for our royalty arrangements, thereby ensuring compliance
  • Serve as a financial liaison and interact with external and internal auditors and business partners, proving the robustness of the internal controls within our royalty processes. This also includes initiating and overseeing audits of our partners’ books

This position is not eligible for relocation.
12/13/17 Associate Scientist / Scientist - Research Mass Spectrometrist Individual Contributor South San Francisco, California

The Structure Elucidation Group  in Genentech's Small Molecule Pharmaceutical Sciences Department has an outstanding opportunity available for a talented and innovative Associate Scientist/Scientist with strong mass spectrometry skills.
 
The role explores and implements new technologies to support the development of novel small molecule therapeutics for the treatment of significant unmet medical needs. The position works collaboratively with scientists from the Analytical, Process Chemistry, and Pharmaceutics groups to investigate side-products, impurities, and degradants in drug substance and drug product development. 
 
This scientist in this position independently designs, plans, and executes protocols to resolve issues related to unknown compound identification.  The right candidate is excited by research at the cutting edge of mass spectrometry, and is able to identify new applications of mass spectrometry that can be applied to small molecule structure elucidation problems to ultimately drive innovation to solve those problems. Highly motivated candidates with a passion for innovation are encouraged to apply.
12/13/17 Intern - Pharma Technical Operations - Submission Management (3-month Internship) Entry Level South San Francisco, California

This is an opportunity within the Submission Management Group (SMG) department in the Pharma Technical Regulatory (PTR) organization.  SMG provides regulatory submission management expertise to PTR submission leads.  SMG plays a critical role in enabling the production of quality regulatory filings across Roche. This is a 3 month Internship.

In this position, you will work with Submission Managers and Information Specialists from our SMG group, PTR submission leads, and submission authors from the technical functions on one or more projects related to the following:
  • Reconciling requests for submission management and improving this system
  • Acting as a liaison between SMG and submission teams with regard to new submission technology systems and processes—answering questions and bringing issues back to SMG for discussion and resolution.
  • Performing discreet editing and formatting tasks on regulatory submissions, including marketing applications, under the direction of a Submission Manager.

You will need to display good technical judgment as part of a team responsible for delivering high-quality biopharmaceutical regulatory submissions to world health authorities. Integrity, accountability, and strong dedication to the patients we serve are critical to this role.

Specific responsibilities for this position may include:
  • Act as a key point of communication with project teams and first line of assistance.
  • Implementation and evaluation of projects with a focus on process improvement and efficiency enhancement.  Interpretation of submission data with a focus on in-depth understanding of processes for identification of continuous improvements.
  • Creation/revision of business processes in collaboration with other departments
  • Summarization of projects highlighting the accomplishments and poster/oral presentation at staff/department meetings.
12/13/17 Principal Project Manager - Pharma Development Strategic Innovation - Informatics Individual Contributor South San Francisco, California

Principal Project Manager - Pharma Development Strategic Innovation - Informatics
Location: South San Francisco, USA or Welwyn, U.K.


The Position

As Informatics Principle Project Manager in the Pharma Development Strategic Innovation - Informatics (“PDSI-I”) team you are responsible for leading various proof of concept (“POCs”) experiments with emerging technologies in clinical trials. You will work closely with our business partners and molecule teams to support scoping the POCs, you will direct team resources, manage vendors, oversee validation, and navigate complex processes to deliver these shorter-term, fast-paced, global projects. In this cross-functional, energetic and highly talented team, we are at the forefront of delivering emerging technology solutions to generate early evidence for the eventual application in Roche clinical trials.

You are an innovation-oriented and determined individual with strong communication, influencing, and relationship building skills. You are willing to be flexible and are comfortable working in an ambiguous environment. Your key responsibilities are to:
  • Develop subject matter expertise in emerging healthcare technologies, innovation practices, Roche clinical trials, and compliance processes
  • Manage all activities associated with successful delivery of multiple concurrent PDSI-I POCs, pilots, experiments or initiatives for emerging technology application in clinical trials. 
  • Co-develop technology experimentation strategies with PDSI Leaders and Business Solution Manager (“BSM”) and then scope the POCs, define key deliverables, and build a comprehensive plan to execute. 
  • Work with the BSM & Team Lead to manage demand, prioritize tasks and track activities, mobilize and monitor resources, and manage budgets and forecasts.
  • Ensure timely, high quality delivery to achieve the POC’s objectives and benefits; proactively resolving scope, schedule, resource and financial conflicts.
  • From time to time, represent PDSI-I at meetings or events held in Europe.
  • Manage all validation and compliance efforts, ensuring that POCs can balance on time delivery of fully compliant solutions at a pace demanded by innovation.
  • Communicate appropriately and effectively with all stakeholders and colleagues.
  • Maintain both internal and external (vendor) relationships pertaining to POCs.
  • Support the gathering & maintenance of internal and external intelligence on various innovation initiatives leveraging specific emerging technologies
  • Support the administration and moderation of our team's online communities
12/12/17 Document Manager, Global Quality Standards Individual Contributor South San Francisco, California

Level:  E4

Location: South San Francisco, CA

 

Please note relocation is not available for this position

 

TECHNICAL DUTIES/RESPONSIBILITIES:

• Technical Writing

o Responsible for ensuring Global Quality Standards (PQS) are aligned with appropriate Health Authority requirements.   Adhere to defined Global PQS QR, GSP, and NSOP templates, including level of detail and document writing standards.

• Adherence to the Global PQS Document Business Process

o Ensure key stakeholders (Authors, Global Coordinators, PQS Site Leads) adhere to the PQS Document Business Process, including adherence to revision/creation process and timely deliverables to ensure on-time approvals.

o Work closely with PQS document authors and SMEs on technical content of Global Standards.

o Provide project management support and work to meet periodic reviews and other defined timelines for document revision.

o Ensure timely completion of PQS forms and final deliverables.

o Document and communicate decisions and issues throughout process for visibility.

o Escalate issues regarding timelines and other potential concerns on the business process.

• Health Authority mapping to PQS document requirements

o Ensure current Health Authority requirements are current in the PQS.

o Maintain the Health Authority Mapping Tool by mapping the Health Authority requirements to Global PQS document and confirm mapping with the PQS Author and Global Standards SME.

o Ensure mapping is documented according to the templates/writing standards.

o Ensure appropriate and accurate citations and references are included in PQS documents

 

12/12/17 Senior Safety Scientist (MD) Individual Contributor South San Francisco, California

The Senior Safety Scientist is responsible for carrying out pharmacovigilance activities for the
assigned product(s). This may include, single case medical review, aggregate reporting, signal
detection and evaluation, safety related activities associated with new drug applications /
regulatory filings, benefit risk assessment and safety risk management.

The Senior Safety Scientist supports the Safety Science Leader (SSL) and may be responsible
for particular aspect(s) of the overall program or a group of products. Applicable tasks are not
limited to and may vary by product(s) assigned.

Primary Responsibilities and Accountabilities

Carry out pharmacovigilance and risk management activities for assigned product(s):

  • Contribute to Pharmacovigilance and Risk Management planning for designated products by preparation of safety surveillance strategy and tracking and evaluating potential issues
  • Senior Safety Scientist may support SSL or be responsible for the development and/or the execution of RMP or REMS risk mitigation activities
  • Prepare and review periodic aggregate safety reports (PBRER / PSUR, DSUR, EU renewal and other Annual Safety Reports) in accordance with regulatory requirements and standard operating procedures
  • Support the preparation and maintenance of safety sections of the Company Core Data Sheet
  • Lead/support PDS post-marketing safety study activities
Carry out signal detection activities and evaluation:
  • Conduct/support signal detection and evaluation according to SOPs and guidelines
  • Carry out medical review of individual case safety reports (ICSRs), if assigned for the product according to SOPs and guidelines
  • Prepare safety assessments, drug safety reports, as necessary, for potential signals or issues (product quality)
  • Respond to safety requests for the assigned product from regulatory agencies or affiliates/ other internal functions
  • Compliance: Support all relevant compliance activities including implementation of assigned CAPAs
Contribute drug safety input to activities to define and implement the Clinical Development
strategy for assigned product(s):
  • Provide safety content review of clinical protocols, study reports, Investigators Brochure and other related documents to ensure alignment with CDP
  • Contribute to regulatory authority submissions (IND applications, NDAs, MAA’s, Variations, Renewals) by reviewing safety data and preparing relevant sections of the filing documents and submission packages
  • Participate in and provide input for Drug Safety Monitoring Boards or independent monitoring committee meetings, as applicable
  • The timely medically and scientifically sound development of the clinical safety portions of a product development plan (PDP) and develop an understanding of the safety profile of the assigned product
Whenever assigned by the SSL, the Senior Safety Scientist is responsible for the development
and whenever appropriates the execution of RMP or REMS risk mitigation tactics.

The Senior Safety Scientist is differentiated from the Safety Scientist in that the incumbent is consistently willing and able to be successful when employed on the most demanding and
complex tasks; has a high degree of independence and autonomy, requiring minimal supervision; is widely respected by other members of the organization for their contribution and competence; acts as a coach, guide, and mentor to peers and direct reports; and makes a contribution to the department beyond the bounds of their routine responsibilities (e.g. in cross-functional teams and working groups).

12/12/17 Investment Manager, Roche Venture Fund Individual Contributor South San Francisco, California

Description of Position:

An Investment Manager of the Roche Venture Fund (“Investment Manager”) supports the Investment Directors in group-wide venture investments and in managing these investments. The Investment Manager may also propose a new investment independent of an Investment Director.

Investments:

  • Source investment opportunities through internal and external network
  • Work with divisional experts to evaluate potential investments. 
  • Make a recommendation to the RVF ream on whether to proceed or not. 
  • Under the supervision of, or provide support to, the Investment Director in planning and executing due diligence, creating a valuation, and negotiating the investment documents. 
  • Provide or support the Investment Director in providing an investment recommendation to the RVF team.
  • If the investment is approved, the Investment Manager is responsible for the logistics of completing the investment including coordinating with in-house & external counsel, cash management, FX management, TOP operations. 
Management:
  • Support RVF in monitoring operational and financial developments at portfolio companies and keeping regular contact with company officers. 
  • Participate in preparation of quarterly updates on the portfolio companies’ development and performance. 
  • Manage contractual issues with assigned portfolio companies, including share conversion, share registration, IPO paperwork, lock-up agreements, acquisitions of portfolio companies.
  • When Roche has a board seat in a portfolio company, this would typically be assumed by an Investment Director but the Investment Manager may either be a board observer where RVF has a board director or the Investment Manager may have a board or board observer seat if appropriate.
  • Prepare board updates for the RVF team following each board meeting of a company that the investment manager has either a board or board observer seat.
Exits:
  • Support the RVF team in managing exits in the portfolio companies, through providing a recommendation to the Head RVF on the timing and pricing of the sales of shares.

12/12/17 Head of Device Development, US Executive (Director/VP/SVP) South San Francisco, California

The Technical Device Development function is a key component of Genenetech and Roche’s Pharma Technical Development organization, providing technologies and strategic support for development and commercialization of a portfolio of combination products. Technology development is directed towards enabling product teams to enable and differentiate our products and ensure Roche is highly competitive in commercial markets.  
  
The Device Development Head is accountable for a project portfolio that consists of approximately 25 development projects and several commercial products in a variety of therapeutic areas including immunology, ophthalmology, oncology, neuroscience, metabolism and infectious diseases. The Head is expected to set and implement strategies desired to drive state of the art technical and product development capabilities including influencing clinical development strategies to enable combination product team success. Technology development is geared towards developing devices that enable products in these diverse areas and ensures ongoing competitiveness.   

The Head must provide effective oversight of an extensive network of external technology and development partners to ensure technology solutions and development programs meet business objectives. The Head of Device Development US partners with their counterpart in Europe and stakeholders in Roche’s global network to maximize effectiveness in managing the Roche combination product portfolio, including cross-functional efforts to select technologies, drive improvements in device product quality, ensure robust manufacturability, enable lifecycle management, and consistently meet evolving health authority expectations. 
   
Specific responsibilities include: 
  • Development and application of a broad range of drug delivery devices, including pre-filled syringes, needle safety devices, auto-injectors, patch infusers, intraocular delivery devices/tools. Additional Drug delivery technology development areas of responsibility include pulmonary drug delivery, manual injection systems, Smart Devices/electronic tools for therapy adherence, and will include other new technology areas in the future.   
  • Perform assessments of new technologies and market trends. Utilize information to inform technology development and provide input to Marketing/Commercial strategies as needed.  
  • Make technology investment decisions to meet budget and business needs. Develop and maintain a current technology strategy - investment decisions based on portfolio needs and market trends in collaboration with key senior level stakeholders in PTD, PD and GPS    
  • Oversight of various Development sub-functions within the Device organization: 
  • Device and Primary Container Design Engineering, including selection of devices to be developed and marketed commercially, evaluation and definition of patient needs, device design/customization and engineering, device clinical testing support and writing sections of health authority filings. 
  • Human Factors Engineering function, which executes the human factors engineering studies for all project teams developing and commercializing a device. This responsibility additionally entails the establishment and continuous improvement of human factors business processes, global internal alignment of approaches for human factors testing, and external influencing of health authorities on best practices in this area. 
  • Device Process Engineering with responsibility for clinical and commercial device assembly process engineering and manufacturability, technology transfer support, product care and commercial manufacturing support, for both the Roche internal manufacturing network and external development/manufacturing partners. 
  • Device Laboratory Operations, which performs analytical characterization and Design Verification testing for all devices and projects in the department.   
  • Design Control function that is responsible for effective execution of Design Control processes and documentation to ensure compliance with global health authority requirements (e.g. FDA 21 CFR Part 4) and technical standards 
  • Device Project Management and portfolio management  
  • Business process ownership and governance processes for Device Development   
  • Managing and annual budget of $25-30MM to meet financial goals and facilitate acquisition of resources / prioritization of workload. 
Broader organizational accountabilities include:   
  • Chair Device Technical Advisory Committee (DTAC), which is accountable for guiding the device strategy and technology development plan for specific development products in US development portfolio.  
  • Represent Device Development in global Technical Development governance forums  
  • Ensure alignment with Technical Device Development-Europe on technology and operational initiatives 
  • Ensure effective communication with research, development and commercial stakeholders across the company to ensure common understanding of the device project portfolio, share current status/issues for projects with respect to meeting product development deliverables and timelines, and sharing technology development progress. This includes, but is not limited to, holding annual DTAC Portfolio Review, publishing regular status reports, joint leadership team meetings with functional counterparts, etc. 
  • Chair External Influencing Steering Committee (EISC) Device Topic Area with the objectives of influencing and shaping global health authorities expectations on key industry topics (cGMPs for combination products, human factors, clinical testing of devices, adverse event reporting, marketing application filing approaches and other topics) 
  • Member of the US Pharma Technical Development Leadership Team, including Bioprocess, Analytical and Pharmacuetical development. Expected to serve as a sponsor to technical development teams beyond the area of devices, and engage in organizational initiatives and leadership in a collaborative manner. 
  • Accountable to ensure quality and accuracy of Device sections of Regulatory submissions and communications  
  • Accountable to assure processes and systems are in place Project team Design History Files meet regulatory requirements and readiness for health authority inspection; ensures effective remediation plans for compliance assessments and audits 
  • Relationship building is key for this role.  The leader must be customer focused and have a deep commitment to working collaboratively to support the global Roche portfolio. As such, the leader will foster an environment of cross-functional collaboration, accountability, and technical rigor in collaboration with the EU Head of Device Development. The successful candidate will provide regular, visible leadership in advancing new device platform technologies and ensuring a positive external reputation in combination product development. The leader must influence across functions to facilitate the overall enhancement of organizational capabilities in device/combination product development in Pharma Technical. This responsibility includes ensuring effective interfaces with Marketing, Quality, Regulatory, Manufacturing, Clinical Development and counterpart technical groups. The leader is responsible for a staff of a growing organization of approximately 80 staff (insourced and regular employees) and technical management of a complex network of numerous (~50) external company partners. 
12/11/17 Sr. Scientific Researcher, Translational Oncology Individual Contributor South San Francisco, California

The Department of Translational Oncology at Genentech is seeking a highly talented, driven and motivated Senior Scientific Researcher to join a group of investigators evaluating novel therapies in the field of cancer immunotherapy. The candidate will explore mechanism of action focusing on both innate and adaptive immune infiltrates, understanding treatment mediated phenotypic and functional changes and exploring potential combinatorial strategies as well as helping to elucidate biomarkers of response. The candidate will work closely with discovery scientists to advance research stage programs into early clinical development, providing both scientific and technical expertise. This position requires in vitro bench work focusing heavily on flow cytometry and other cellular in vitro functional assays.
 
12/11/17 Manager Quality, EQA Manager with Direct Reports South San Francisco, California

Location: South San Francisco, CA

 

Please note relocation is not available for this position

 

Main Purpose of the Position:

• Manage the planning, preparation, and conduct of Quality Assurance staff performing a variety of routine and complex oversight activities that meet cGMP regulations and Genentech standards.

• Develop solutions to complex issues and Quality initiatives with inter-organizational impact associated with Environmental Monitoring (EM) following cGMP regulations and Genentech standards.

• Manage the aseptic media fill program, air flow visualization program and provide oversight of EM activities, ensuring the programs are consistent with company procedures and cGMP regulations.

Job Duties/Responsibilities:

• Manage and administer all aspects of people processes related to the employee life cycle.  This includes the selection, hiring and training of personnel on company and department policies, systems and processes.

• Be an engaged member of the extended Quality leadership team, actively contributing to long-term vision, strategy, goals and objectives.

• Manage and communicate compensation related information per company guidelines.

• Coach and develop staff by providing an environment that encourages ongoing personal and professional development. 

• Manage and ensure the setting of realistic goals for staff and provide regularly scheduled feedback throughout the year.

• Ensure staff receives appropriate knowledge, skill development and growth opportunities.

• Recommend and implement improvements to Quality operational policies, plans and procedures.

• Manage routine department activities and complex Quality initiatives.

• Ensure activities and initiatives are completed on time and within budget.

• Monitor and control expenditures against the department budget.

• Notify Senior Management of potential quality or regulatory issues that may impact product quality or regulatory compliance.

• Lead and participate in continuous improvement initiatives.

• Sign documents for activities as authorized and described by Genentech policies, procedures and job descriptions.

• Be accountable for behaviors described in Genentech’s Core, Common and Critical Competencies.

• Perform any other tasks as requested by Senior Management to support Quality oversight activities.

 

Technical Duties/Responsibilities:

• Provide Quality oversight to ensure a compliant EM program.

• Provide technical assessment and approval for changes to the EM, air flow visualization and media fill programs. Review and approve EM, air flow visualization and Media Fill program documentation.

• Manage staff conducting oversight activities for corporate quality systems including EM and media fill Programs.

• Ensure Corporate Quality systems described in policies and procedures are linked to business and site processes.

• Monitor emerging regulatory trends to assess impact on the business and influence policy development.

• Present and provide rationale for the media fill program and EM programs during periodic audits and regulatory inspections.

• Provide Quality authorization in support of facility and utility restarts and following facility-wide shutdowns.

• Provide input into investigations and deviations involving suspect equipment, utility or facility failures resulting from EM or media fill activities.

• Identify, design, and recommend control enhancements, operations improvements, personnel training, and other corrective actions as appropriate.

• Serve as a subject matter expert (SME) and resource for internal and external customers on EM, media fill, air flow visualization and aseptic processing principles and standard practices.

 

12/11/17 Postdoctoral Research Fellow, James Ernst Lab, Genentech Research Individual Contributor South San Francisco, California

We are seeking a highly motivated postdoctoral research fellow to join the Ernst and Hoogenraad Labs in the Departments of Protein Chemistry and Neuroscience within Genentech’s Research and Early Development organization. The ideal candidate for the position will use a variety of biochemical, cell biology and biophysical techniques to understand the fundamental processes of trafficking, endocytosis and/or receptor-ligand interactions.

The Ernst Lab focuses on the areas of large molecule drug development, particularly in the area neurodegenerative disease. Among our interests, is the tissue targeting of biologic molecules, antibodies and signaling molecules. A long-term goal of the group is to understand how antibodies traffic within tissues, especially at the blood-brain barrier, and to identify novel drug targets or methods to improve the potency of therapeutic candidates against existing targets.

Selected publications form the Ernst Lab:

Selective Homogeneous Assay for Circulating Endopeptidase Fibroblast Activation Protein (FAP). Bainbridge, T. W., Dunshee, D. R., Kljavin, N. M., Skelton, N. J., Junichiro Sonoda, J., and Ernst, J. A. (2017) Scientific Reports

Effector attenuating substitutions that maintain antibody stability and reduce toxicity in mice. Lo M, Kim HS, Tong RK, Bainbridge TW, Vernes JM, Zhang Y, Lin YL, Chung S, Dennis MS, Zuchero YJ, Watts RJ, Couch JA, Meng YG, Atwal JK, Brezski RJ, Spiess C, Ernst JA. J Biol Chem. 2017 Jan 11.

Fibroblast Activation Protein Cleaves and Inactivates Fibroblast Growth Factor. Dunshee DR, Bainbridge TW, Kljavin NM, Zavala-Solorio J, Schroeder AC, Chan R, Corpuz R, Wong M, Zhou W, Deshmukh G, Ly J, Sutherlin DP, Ernst JA, Sonoda J. 21. J Biol Chem. 2016 Mar 11;291(11):5986-96.

Crossing the Blood-Brain Barrier in Non-Human Primates with TfR Bispecific Antibodies. Sci Transl Med. Yu YJ, Atwal JK, Yin Zhang, Tong RK, Wildsmith KR, Tan C, Bien-Ly N, Hersom MMaloney JA, Hoyte K, Luk W, Lu Y, Ernst JA, Couch JA, Dennis MS, and Watts RJ. 2014 Nov 5;6(261):261ra154. doi: 10.1126/scitranslmed.3009835.

Discovery of Novel Blood-Brain Barrier Targets to Enhance Brain Uptake of Therapeutic Antibodies. Zuchero YJ, Chen X, Bien-Ly N, Bumbaca D, Tong RK, Gao X, Zhang S, Hoyte K, Luk W, Huntley MA, Phu L, Tan C, Kallop D, Weimer RM, Lu Y, Kirkpatrick DS, Ernst JA, Chih B, Dennis MS, Watts RJ. Neuron. 2016 Jan 6;89(1):70-82.

Molecular Mechanisms of Alzheimer's Disease Protection by the A673T Allele of Amyloid Precursor Protein. Maloney JA, Bainbridge T, Gustafson A, Zhang S, Kyauk R, Steiner P, van der Brug M, Liu Y1, Ernst JA*, Watts RJ*, Atwal JK. J Biol Chem. 2014 Sep 24. pii: jbc.M114.589069.

Selected publications form the Hoogenraad Lab:

Dynamic Palmitoylation Targets MAP6 to the Axon to Promote Microtubule Stabilization during Neuronal Polarization. Tortosa E, Adolfs Y, Fukata M, Pasterkamp RJ, Kapitein LC, Hoogenraad CC. Neuron. 2017 May 17;94(4):809-825.e7. doi: 10.1016/j.neuron.2017.04.042.

DeActs: genetically encoded tools for perturbing the actin cytoskeleton in single cells.
Harterink M, da Silva ME, Will L, Turan J, Ibrahim A, Lang AE, van Battum EY, Pasterkamp RJ, Kapitein LC, Kudryashov D, Barres BA, Hoogenraad CC, Zuchero JB.
Nat Methods. 2017 May;14(5):479-482. doi: 10.1038/nmeth.4257. Epub 2017 Apr 10.

Probing cytoskeletal modulation of passive and active intracellular dynamics using nanobody-functionalized quantum dots. Katrukha EA, Mikhaylova M, van Brakel HX, van Bergen En Henegouwen PM, Akhmanova A, Hoogenraad CC, Kapitein LC. Nat Commun. 2017 Mar 21;8:14772. doi: 10.1038/ncomms14772.

Quantitative Map of Proteome Dynamics during Neuronal Differentiation. Frese CK, Mikhaylova M, Stucchi R, Gautier V, Liu Q, Mohammed S, Heck AJR, Altelaar AFM, Hoogenraad CC. Cell Rep. 2017 Feb 7;18(6):1527-1542. doi: 10.1016/j.celrep.2017.01.025.


For more information on James Ernst lab, please visit:
https://www.gene.com/scientists/our-scientists/james-ernst

Information about the postdoctoral program at Genentech can be found at:
http://www.gene.com/careers/academic-programs/postdocs


12/11/17 Assistant / Associate Medical Director, ECD Oncology - Personalized Cancer Vaccine Individual Contributor South San Francisco, California

GENERAL POSITION SUMMARY/PURPOSE:
gRED’s Exploratory Clinical Development organization is responsible for developing and executing early development clinical strategies and plans to provide proof-of-concept data with respect to safety, efficacy, and the utility of biomarkers for gRED NMEs. These ECD strategies and plans enable decisions regarding initiation of pivotal studies (i.e., the life-cycle investment point [LIP] decision) and the initial scope of post-LIP development. The Associate gRED Medical Director participates in development of clinical strategies and plans for the assigned molecule(s)/indication(s) and helps ensure effective and efficient execution of the clinical development plan (CDP). gRED Associate Medical Directors operate with oversight from more senior gRED Medical Directors.

JOB DESCRIPTION – PRIMARY DUTIES AND RESPONSIBILITIES:

1. Cross-Functional Team Membership

  • Leads or is a standing member of the Clinical Science Team (CST)
  • Can represent Clinical Science (CS) in cross-functional teams (e.g., Protocol Execution Teams [PETs]) relevant to assigned molecule(s)/indication(s), and helps ensure cross-functional integration, coordination and alignment to enable effective and efficient CDP execution
  • As requested, supports the CSTL and overall team with training new CST members
  • May also, as appropriate, support relevant sub-teams in orienting new team members to the team/NME
2. Clinical Development Planning
  • Stays abreast of internal and external developments, trends and other dynamics relevant to the work of ECD to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for their assigned NME(s).
  • Maintains the highest standards and levels of scientific and clinical knowledge in the therapeutic and disease area(s) relevant to their assigned NME(s).
  • Participates in clinical strategy development, collaborating with a variety of internal and external partners and stakeholders, such as clinical investigators, scientists and key opinion leaders (KOLs), as well as multidisciplinary internal groups, including other groups in gRED Early Development and Global functions such as research, clinical operations, drug safety, regulatory, portfolio management, business development, Product Development, market planning, legal, etc., and may present to various internal committees
  • Participates in development of the CDP for assigned molecule(s)/indication(s): 
    • Gathers and analyzes data and information necessary to create the CDP
    • Works with other CST members and relevant sub-teams to develop CDP components (e.g., safety monitoring, biomarker strategy, biologic and clinical proof-of concept, etc.)
    • Directs CST and works with other relevant sub-teams to develop and provide information and input for budget/resource requirements necessary to implement and execute the CDP
  • Participates in competitive intelligence activities, and other market/industry assessments and projects as appropriate
  • As assigned, supports the transition of NMEs from LSR into ED, and ED into ECD, including contributing to the IND, IB and Phase Ia protocol.
  • Supports other CST members with development of clinical science information for inclusion in project review activities (e.g., Molecule Asset Plan [MAP] reviews) and, as an NME approaches LIP, the Integrated Development Commercialization Plan (IDCP).
  • As appropriate, may participate in Business Development assessments of relevant acquisitions, joint ventures or other strategic partnerships, as these potentially relate to the assigned therapeutic/disease area(s).
  • Supports preparation for HA meetings and, as appropriate, participates in HA meetings. Ethically, effectively and professionally represents the interests of gRED and patients.
3. Clinical Development Plan Implementation
  • Provides clinical support across all relevant studies and programs:
    • With oversight, designs clinical studies and develops protocols
    • Acts as medical monitor for assigned studies
  • Supports clinical operations, clinical research organizations (CROs), etc. by acting as a point-of-contact for questions, other communications, and interactions regarding assigned studies
  • May contribute to the identification and selection of appropriate external investigators and sites
  • Collaborates with others in development of study analytics and data management plans
  • Conducts or collaborates with other CS personnel on ongoing reviews of study medical/safety data for accuracy
  • Collaborates with relevant teams and other groups to measure and monitor study progress against objectives and plans, including any variances, and proactively communicate any issues, challenges and potential strategies for resolution
  • Reviews study data to ensure correct medical/scientific data interpretation, and otherwise supports interim (as needed) and final study reporting
  • Participates in investigator meetings and other external presentations, meetings and other communications
  • Supports, as needed, completion of interim study reporting
  • Works closely with clinical operations and other CST members to close-out clinical studies, secure data and complete study reporting
    • Collaborates with drug safety representatives and others in the development of the product safety profile
    • Collaborates with other CST members and others in development/revision of investigator brochures, presentations and other materials
    • Participates in the development and implementation of communications strategies to support existing and concluded studies. Includes KOL interactions, advisory boards, major medical meetings, congresses and other events, publications and other materials
    • Works with other CST members, regulatory and other internal partners/stakeholders in the completion and submission of regulatory filings and other regulatory documentation. Supports others with clinical science information and input for regulatory submissions and other regulatory processes.
  • Contributes to presentations that provide updates on strategies, plans and other activities, as needed.
  • Works with other CST members in ongoing data generation, review, and communication to inform or enhance the design or interpretation of ECD studies or other programs in the assigned therapeutic area
  • Completes other special projects as assigned
  • Consistently complies with all governing laws, regulations, gRED Standard Operating Procedures (SOPs) and other guidelines.


12/11/17 Principal/Sr, Project Manager IT, Group Informatics - IT Americas Individual Contributor South San Francisco, California

Job Description:

 

Reporting to the  Head of Channel Operations IT, the Principal Project Manager is responsible for  managing the portfolio of projects necessary for the effective and efficient  implementation of large and complex programs/projects in support of Product  Launches for US Commercial Operations.


This role will  establish and execute governance, planning, and communication processes that  allow for deep collaboration and coordination within gCOI and business partner  organizations that will result in planned predictable performance of  implementation projects with positive impact on the users. The implementation projects may be resourced directly out of the solutions delivery organizations  in gCOI.


Examples of  projects/programs include: Product Launches in Biooncology, Immunology, Neurosciences, and other therapeutic areas, and Line Extensions for existing  products, including a higher volume anticipated in coming years for combination  therapies.


Specific Duties  and Responsibilities:

  • Decision Making
    • Make broader and  more complex project or program decisions across multiple areas in consultation  with customers, which include Brand Leaders and other Commercial groups like  Access Solutions, Field Analytics and Operations, and Managed Care and Customer  Operations.
    • Evaluate  tradeoffs and make appropriate decisions on a wider scale, in consultation with  stakeholders from IT Solution Owners across the gCOI organization.
    • Expected  to provide options and recommendations to senior executives
  • Project/Program  Management
    • Define, plan, and direct the execution of a broad range of medium to complex technical  programs/projects, while balancing the competing demands of scope, time, cost, quality, resources, and risk
    • Oversee the work  of other Project Managers and IT Leaders across the gCOI organization who are  assigned to Product Launch efforts.
    • Identify, acquire, and lead multifunctional project teams
    • Manage a  portfolio of projects, in addition to individual projects assigned to the  position
    • Facilitate  project/program management activities across the entire project management  methodology
    • Plan, baseline, and control costs to ensure projects are completed within approved budget
    • Ensure  successful and timely completion of deliverables by tracking progress against  baseline schedule
    • Formulate risk  mitigation strategies and recommend solutions
  • Customer/Stakeholder Management
    • Act as an advisor  to management and customers on program or portfolio matters.
    • Present complex  information, issues and potential solutions to the Senior IT Management, Senior  Customer Management, and Executive Teams.
    • Create collaborative  partnerships, with customers, vendors and other Roche teams to achieve project/program  objectives
    • Ensure project/program  objectives/requirements are clear and agreed to by all stakeholders
  • Process/Communications/Governance/Compliance
    • Establish  appropriate levels of project/program governance which may include steering  committees, PMO, etc.
    • Establish and  maintain effective communication for assigned projects and with dependent  projects and integrated solutions.
    • Suggest  improvements where necessary / appropriate to improve operational efficiencies
    • Identify and  apply systematic quality activities to ensure that projects employ all  processes needed to meet Computer System Validation directives
    • Conduct risk  management planning, identification, analysis and monitoring on projects
    • Manage the  processes required to ensure timely and appropriate generation, collection, distribution, storage, retrieval, and ultimate disposition of project  information and documentation necessary for successful communications across  all stakeholders and any required updates to living system documents for  validated systems
  • Other duties as  assigned


12/11/17 Senior Scientific Researcher, Molecular Biology lab, Genentech Research Individual Contributor South San Francisco, California

We are seeking a Senior Scientific Researcher in the Department of Molecular Biology to support the production and optimization of genetically-modified cellular models. This position will be within the newly-established Cell Engineering Lab, wherein she/he will facilitate the design, execution, and validation of cell line engineering projects initiated by researchers across Genentech -- with the ultimate goal of generating more effective in vitro/ex vivo disease models and novel contexts for functional genomic screening. The candidate is expected to work creatively and independently within an extremely dynamic, collaborative research environment.

12/11/17 Scientific Manager, Cell Engineering Lab, Genentech Research Manager with Direct Reports South San Francisco, California

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


12/11/17 Scientific Communications Director (Immunology) Individual Contributor South San Francisco, California

We invite you to become a member of our exciting Global Ophthalmology Franchise Team as Scientific Communications Director, based in Genentech in South San Francisco

The Scientific Communications Director (SCD) is a key role in the Global Medical Affairs Team responsible for the development of Scientific Communications Strategy as part of the medical strategy and its implementation

We Offer: the Role’s Scope and Responsibilities

You are contributing to the planning and implementation of the Annual Medical strategy

  • Responsible for the development of the scientific communications strategy and dissemination of data for the assigned disease area through an integrated scientific story
  • Publications strategy (incl. planning and management), medical education (internal & external) and management of scientific communications focused activities related to insights generation and congresses
  • SCD identifies the audience, defines the channels and the content of all scientific communication activities for the assigned disease area and/or brand/molecule
  • SCD brings consistency across all scientific communication activities to the Global Medical Team, and drives excellence and innovation in these areas


12/8/17 Training and Development Specialist, HR Individual Contributor South San Francisco, California

Position Overview:

The Training & Development Specialist supports the development, delivery and measurement of learning solutions for Genentech.  This position executes the Corporate New Hire Orientation Program, supports the business to provide learning solutions as requested, provides metrics and analysis on the Learning & Organization Development (L&OD) offerings and portfolio as well as manage all aspects of the budget (Contract to Invoice) for assigned programs and projects.  This position serves the function that deploys learning solutions and works with program managers, subject matter experts, instructional design/developers, external vendor teams, business partners, and others to optimally implement and measure learning solutions.


Responsibilities:

  • Oversee operations and lead the Corporate New Hire Orientation Program including facilitation, vendor management, logistics coordination, technology support and point of contact for new employees and their managers.
  • Partner with Program Manager to maintain content, implement program updates and process improvements for Corporate New Hire Orientation.
  • Manage all operations for various curriculum offerings including budget, learning management system, day of support, coordination, evaluation and others as identified.
  • Partner with Program Managers to implement new curriculum offerings and/or update current offerings.
  • SME for all L&OD reporting needs including data collection, metric insights and all other needs as requested.
  • Define and manage work plans and provide oversight for ongoing changes, training, testing, and system support for department.
  • Participate on cross functional teams (interdepartmental and external).
  • Assist with maintaining project budgets and resources, both internal and external.
  • Execute all other responsibilities as assigned and as required by manager
This position is not eligible for relocation.

Important Information

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

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

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