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Date Job Title Job Level Location
8/17/20 Sr Clinical Trial Leader/Clinical Trial Leader Individual contributor South San Francisco, California

Role Responsibilities/Accountabilities:

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

  • Provide direction and leadership (support for Sr CTLs) to one of more SMTs to ensure delivery of all cross functional activities to meet study plans outlined in medical plans
  • Chair SMT meetings and other meetings involving external stakeholders (Investigator, Steering Committee, Vendors as appropriate). Primary SMT contact for key internal stakeholders.
  • Represent the SMT at various cross-functional teams (medical team, filing team) as required, and may serve as an ad hoc member
  • Build and maintain effective high performing SMTs by ensuring clarity of roles, responsibilities, accountabilities and deliverables for members
  • Ensure SMT receives applicable training; including therapeutic area training, protocol training, etc at study kick-off
  • Contribute clinical operations expertise into Medical Plans and study design
  • Provide Contract Research Organization (CRO) and other vendor direction and oversight
  • Ensure assigned SMTs and vendor partners deliver on commitments to agreed targets
  • Ensure study adherence to budget, ICH-GCP standards, Genentech/Roche SOPs and other operating guidelines and regulatory requirements and proper escalation of issues and risks to the medical team (via CPL).
  • Finalize study budget based upon high level estimate from CPL, input from CTL (if available) and in alignment with project and study-level assumptions
  • Accountable for study budgets, with appropriate input from the CTL (if available) to ensure efficient expenditure and minimal variance between actual and planned spend. Accountable for accuracy of forecasting and ensuring adjustments are made as necessary (via CPL consult)
  • Compliantly develop and cultivate productive relationships with external partners/stakeholders
  • Create and manage risk and quality plans that are robust, proactive and implemented for each assigned study
  • Contribute to study management and clinical operations excellence by identifying opportunities, mitigating risks and supporting continuous improvement
  • Responsible for driving and making clear study-level decisions in the project team environment
  • Ensure all relevant functional groups provide input to develop and finalize core study documents including protocol, informed consent form, CRF, and various operations documents.
  • Ensure clinical data are reviewed in accordance with the study data plans
  • Oversee the safety reporting activities and ensure reporting timelines are met
  • Identify and contribute to areas of best practice and process improvements
  • Provide study specific mentoring to CTLs (if available) and Clinical Trial Associates (CTAs) and partners with Clinical Operations Leaders (COLs) to contribute to CTL and CTA development needs

In this position, you will be responsible as an Operations representative to:

  • Serve as a member of one or more global cross-functional Study Management Teams (SMTs) and Study Review Teams (SRTs) through all study stages (start-up, conduct, close-out) to contribute to the accomplishment of studies outlined by the medical plan
  • Participate in developing and finalizing cross-functional activities to ensure delivery of critical clinical trial documents such as informed consent forms (ICFs), protocols, site and country budget templates, EDC, IxRS, central/specialty lab, ECG, imaging, and PRO specifications, drug supply and biomarker/sample management plans, TMF, and CSRs. Liaise with cross-functional team members including the SMT members to solicit input
  • Responsible for leading identification and selection of vendors; ensuring appropriate cross-functional input is incorporated into the scope of work
  • Support Clinical Trial Management System (CTMS) systems and data maintenance
  • Actively partner with Data Management and Medical team to oversee eCRF completion and data quality issues
  • Develop/track operational activities such as budget, timelines, milestones, and critical study activities; identifying issues and proposing potential resolutions
  • Lead the development of protocol level feasibility and finalize country/site selection with Clinical Program Leader (CPL) input
  • Develop and actively manage the study patient recruitment strategies
  • Provide input into the study budget and manage assigned vendor budget(s); communicate variances in actual versus forecasted spend in vendor budgets and present an action plan for resolution to the CPL
  • Participate in selection of vendors (participate in the Request for Proposal [RFP] process), in collaboration with the Sr. CTL and/or CPL
  • Utilize outputs from operational analytical tools to enhance and improve study execution
  • Oversee delegated outsourced activities to ensure Contract Research Organization (CRO) and vendor delivery against contracted scope of work.
  • Responsible for assessing feasibility of and driving execution/adherence to protocol and amendments or changes to clinical studies, across functions
  • Contribute to study site selection and management
  • Assist with all activities related to site selection, contracting, set-up and maintenance
  • Partner with Site Contracts on development of site budget template and budget negotiations
  • Proactively identify risks and develop risk mitigation strategies to ensure operational effectiveness
  • Coordinate planning and execution of effective investigator meetings. As appropriate/applicable, drive agenda and content for investigator meetings
  • Ensure accuracy and timeliness of CTMS, timeline planning tools and other core systems
  • Accountable for drug supply requirements and availability across studies in liaison with the Pharma Technical Drug Supply group
  • Ensures completion and finalization of any corrective and preventative action plans resulting from site audits
  • Identifies areas of best practice and process improvements
  • Ensure study adherence to ICH/GCP and SOPs

Other:

  • Stay current on relevant therapeutic knowledge and clinical research best practices
  • Participate in the evaluation of standards across one or more SMT(s)/SRT(s) with the objective of enhancing quality, productivity and efficiency
  • Provide support, mentoring and study-specific training to other USMA Clinical Operations team members
  • As appropriate, serve as subject matter expert on task forces, initiatives and various working groups; contributing to USMA and USMA Clinical Operations initiatives

CMG Operating Principles

I put the patient first, always

I am obsessed with meeting customer needs

I act on behalf of the whole company, not just my team

I am inclusive

I have a growth mindset

I act with urgency

I am accountable

I radically simplify and prioritize for impact

I follow the science

I build our reputation

External Link: https://www.gene.com/careers/commercial-operating-principles



 

8/11/20 Account Executive Individual contributor Taipei, Taipei City

Sell and promote products in retail/OTC pharmacists to achieve sales target and related KPI. (在零售通路上銷售及推廣Roche Accu-Chek血糖機相關產品以達成銷售目標及各項KPI指標)

主要工作職責 Main Tasks & Responsibilities :

• Achieve sales target and KPI of the assigned territories as per sales plan 達成公司所訂之業績及各項KPI指標

• Accelerate product off-take in trade and manage trade inventory 加速產品迴轉及店頭庫存管理,根據公司所訂之目標

• Follow reporting and college needs as defined by company 遵守並回報公司對業務拜訪行程及客戶拜訪數之規定

• Secure Accu-Chek market share in the retail 鞏固Accu-Chek之零售通路市場領導市佔率

• Implement marketing program to meet objective and implementation quality 執行行銷活動及確保行銷目標及執行品質之達成

• Build strong relationship with retailer and motivate they purchase and sell Accu-Chek 與零售店頭建立強而有力之關係,並鼓勵他們購買及銷售 Accu-Chek產品

• Develop sales strategies against competitors 發展業務對策以防範或對制競爭者

• Implement in-store merchandising timely and accurately to increase Accu-Chek brand exposure 執行陳列必須及時及準確以增加Roche品牌店頭之曝光率

• Provide required reports on-time and accurately 準時及正確提供公司要求之報表

1. At least 3-5 years working experience in sales (in medical related or consumer health care is a plus) 2. Attitude: Positive, creative, pro-active, team work, quick learner, logistical thinking, organized. 3. Good communication skills. 4. Excellent skills in Window system. 5. Good command in English reading, speaking and writing would be plus.

8/11/20 Sr Scientific Researcher (Development) Individual contributor South San Francisco, California

We are seeking a highly motivated Senior Scientific Researcher to join the Effector Function and Cell Biology group in the BioAnalytical Sciences Department at Genentech, Inc.  Our group is responsible for all cell-based assays that support in vitro biological characterization and immunogenicity assessment of antibody therapeutics.  The successful candidate will be responsible for developing, optimizing, validating and executing biochemical and cellular assays to support research and development projects in our South San Francisco location with a focus on immune activation assays and immunogenicity assessment.  This individual will work in a fast-paced environment with a high degree of autonomy to design and run experiments, interpret data and troubleshoot technical problems, write and review technical reports, and present and interpret data at cross-functional project team meetings. This individual is expected to become a resource for cell-based assays within the department, may also be expected to mentor more junior colleagues, to lead or assist the investigation and assessment of new technologies, and represent BAS on cross-functional teams.

Requirements

  • A B.A. or B.S. in Biochemistry, Cell Biology, Immunology, or a related field is required, with a minimum of 8 years hands-on laboratory experience in immunoassays, cell culture, flow cytometry, and immune activation assays.  
  • Practical knowledge and understanding of standard laboratory procedures and computerized data handling are essential.  
  • Excellent written and verbal communication, interpersonal, multitasking and organizational skills are required.
  • This individual should be able to work independently, as well as within teams, to demonstrate initiative and creativity and to prioritize tasks.

#DevSci

#BAS

#LI-BJ1

8/11/20 Senior Scientific Researcher Individual contributor South San Francisco, California

The Position

We are seeking a highly motivated Senior Scientific Researcher to join the Microchemistry,

Proteomics and Lipidomics (MPL) Department to perform mass spectrometry centric translational research. Within MPL we develop and implement cutting edge proteomic strategies to support numerous exciting discovery and pre-clinical projects throughout Genentech Research & Early Development (gRED). In this role, you will be making a significant contribution to our pipeline by characterizing peptides presented to the immune system on MHC molecules (immunopeptidomes) and performing research to better understand peptide processing and presentation mechanisms. Due to the translational nature of this work, you will also have the opportunity to work closely with Cancer Immunology teams developing emerging therapeutic technologies.

Job responsibility:

  • Immunopeptidome sample preparation, including development of automated procedures
  • Development and implementation of mass spectrometry methods for immunopeptidomic analysis (data dependent & targeted analysis).
  • Perform computational analysis to interpret immunopeptidomic, proteomic, and potentially RNAseq data.
  • Cell culture of both adherent and suspension cell lines
  • Prepare presentations and communicate results with key stakeholders
  • Work independently, as well as a key player in a multidisciplinary team to move project forward

Successful candidate will have the following attributes:

  • PhD in chemistry, biochemistry, or immunology with >4 years hands-on experience in immunopeptidomics
  • Capable of independent proteomic data analysis with an emphasis on analyzing data within R
  • Experience developing automated sample preparation methods
  • Good understanding of biological pathways of MHC peptide presentation
  • Highly-organized, detail-oriented and excellent problem-solving skills
8/11/20 Scientific Researcher/Sr. Scientific Researcher - Stem Cell Biology Individual contributor South San Francisco, California

We are looking for an exceptional Scientific Researcher / Senior Scientific Researcher to join the Biochemical and Cellular Pharmacology (BCP) Department within Genentech's Research and Early Development (gRED). The candidate will be responsible for the optimization and execution of functional pharmacology assays especially utilizing stem cell-derived complex cellular or 3D organoid models by combining molecular biology techniques to support our protein therapeutic discovery programs for the selection and advancement of lead molecules.

Responsibilities

The successful individual will be focused on implementing new stem cell-based in vitro cellular models to validate and execute medium and high-throughput biochemical and cell-based functional assays to identify and characterize drug candidate molecules. Besides, he/she will be expected to independently design, implement, troubleshoot, and contribute to the data analysis and present work to project teams. In addition, the individual will be expected to incorporate lab automation in his/her workflow and harness novel technologies in assay development.

The candidate will function as part of a multi-disciplinary project team that will coordinate with Antibody Engineering, Protein Chemistry, Therapeutic Areas, and Translational Research groups to advance the projects’ lead molecules.

Qualifications:

  • B.S. or M.S. degree in Biochemistry, Cell and Molecular Biology or closely related fields.
  • At least 2 years (SR) or 6+ years of research experience in academia, biotechnology, or biopharmaceutical experience in the field of stem cell biology is preferred.
  • Proven expertise in the design, development, validation, and execution of biochemical and cell-based assays.
  • Experience with the mammalian cell culture and preferably culturing primary cells, ESCs, iPSCs, In-vitro differentiation of ESC/iPSCs and 3D organoids.
  • Familiarity with cell biology techniques such as Immunofluorescence, tissue cryosections, high-content imaging, and image analysis.
  • Experience with gene editing and cellular reprogramming will be plus.
  • Ability to work independently to design, execute, and interpret experiments, and also to collaborate well with project teams
  • Record of achievement including publications that demonstrate expertise and knowledge.
  • Precise documentation of SOPs and results.
  • Excellent teamwork, oral/written communication, time management, analytical, critical thinking, and organizational skills
  • A passion for science and good experiences with interdepartmental and/or external collaborations
8/11/20 Applied Analytics Manager, Web & Mobile Individual contributor South San Francisco, California

Purpose

Digital Customer Experience (DCX) is a functional group within Genentech Business Operations (GBO) comprised of experienced digital specialists who partner across CMG to orchestrate and deliver integrated digital customer experiences that drive measurable business outcomes.

The applied analytics manager for Web & Mobile will be a key member of the Web & Mobile team as well as the Applied Analytics team. They will use their deep analytical knowledge of web and mobile, such as segments, propensities, channel preferences and other behavioral analyses, to drive strategies and optimization recommendations for digital campaigns. They will continually strive to drive results through robust insights, championing experimentation and educating partners and stakeholders on best practices, tools and capabilities.

Key Responsibilities
  • Planning & Optimization

    • Responsible for developing repeatable web & mobile analytics services such as targeting, segmentation, channel and content preferences and impact measurement

    • Analyze web & mobile data to inform optimal design of web & mobile properties

    • Responsible for developing business, customer and operational KPI’s

    • Responsible for developing x-portfolio and industry benchmarks

    • Monitor individual brand performance and portfolio measures to identify opportunities for improvement; lead hypothesis generation and optimization strategies with service teams and product marketing

    • Apply cross portfolio learnings to improve operational best practices in order to maximize business outcomes

    • Partner with relevant analytics functions in CMG to develop holistic insights on customers and campaigns

  • Test & Learn

    • Drive a culture of testing & learning within the service and COE

    • Partner across services to develop novel approaches to testing and learning to drive better customer experiences

    • Responsible for building brand and cross portfolio learning agendas that inform service roadmap and best practices

  • Advancing analytics and data capabilities

    • Partner with BI team to scale analytics for web & mobile by building self-service decision-making tools for internal team members and product marketing stakeholders

    • Collaborate across services and platforms to inform decisions on data and analytical capabilities within DCX

    • Train DCX and CMG stakeholders on web & mobile analytics and optimization capabilities

Skills & Competencies
  • Passion for data and analytics

  • Experience in sales and marketing analytics in healthcare

  • Strong analytical and critical thinking skills with a bias for action

  • Goal oriented and customer centric

  • Ability to inspire action through story-telling and synthesis of data

  • Enterprise thinking and ability to lead the creation of decision-support tools that are repeatable and scalable

  • Financial acumen, including budgeting and forecasting

  • Possesses a mindset of experimentation and learning

  • Experience creating learning agendas in a digital marketing environment

  • Experience with common web & mobile analytics

Qualifications & Experience
  • Bachelor’s degree in Business or Engineering

  • MBA or other related graduate degree preferred

  • 10 years of experience in digital marketing

  • 6 years of experience in web & mobile analytics

  • Experience with BI and web & mobile analytics tools (e.g. Adobe Analytics, Google Analytics)

  • Experience in the managed care, pharmaceutical or biotech industry

#LI-KG1

8/11/20 Group Director, Digital Safety & Decision Support Technologies Manager with direct reports South San Francisco, California

 Group Director, Digital Safety & Decision Support Technologies



 

Who We Are

At Roche, we are passionate about transforming patients’ lives and we are fearless in both decision and action - we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow.

Role Purpose

As a member of the functional leadership team within Pharmacovigilance & Scientific 

Development at Roche, the Group Director is accountable for building and leading a team that provides strategic expertise in relation to digital safety solutions, decision support technologies, and safety knowledge management technologies. With the ultimate aim of supporting more effective benefit-risk decision input; communication of clinical risks; improved patient risk management; and healthcare stakeholder engagement; by the whole Roche Safety community.  

The jobholder therefore plays a pivotal role, partnering with a wide range of stakeholders across the Roche Safety community, the wider Roche enterprise, and externally. They and their team will identify, progress and implement relevant technological safety innovations, in close collaboration with a range of partners. The jobholder will play a key role in shaping and implementing relevant aspects of the Roche Safety Strategy and therefore contributing to the overall Pharma Ambition at Roche. 

This is a newly created role and team, and the jobholder will therefore have the opportunity to shape the remit of the team as it evolves, in collaboration with their stakeholders and customers. Expected areas of accountability would include, but are not necessarily limited to those outlined below: 

Safety Decision Support Technologies: Accountable for identifying and progressing technologies that can support and improve safety surveillance and scientific/medical safety decision-making. This may encompass novel solutions for signal identification, evaluation and medical decision making. Or technologies that can improve the integration and exploitation of emerging/varied scientific data sources (e.g. EHRs, patient insights data, genomics data). To achieve this it will require extensive collaboration and fostering of strong partnerships with safety and technology stakeholders across the Roche enterprise and externally. The Group Director, will maintain knowledge of current and evolving technologies and trends, that can enable safety-related decision support, and support the co-creation of cross-functional technology plans. 

Safety Digital Strategy & Channels: Accountability for ensuring that a digital safety strategy and plan is developed, sustained & implemented, in partnership with relevant wider stakeholders. This would include planning the development and adoption of technologies to support digital clinical risk communication, improved patient risk management, and the understanding of patient or market insights in areas such as clinical risk education & awareness.

Safety Collaboration & Knowledge Management (KM): Accountable for managing the safety technology strategy to support the Roche Safety Community’s ability to manage and share key knowledge, and to collaborate more effectively across boundaries, both globally and locally. This may include responsibility for planning novel KM solutions that are relevant to safety activities, and/or ensuring that enterprise-wide collaboration platforms can be fully utilised by safety roles. In turn this could support wider collaboration between global and affiliate-based safety stakeholders; or optimal use of safety learning resources and knowledge repositories. To support these activities, the jobholder would ensure their team collaborates closely with wider stakeholders supporting safety records management & retention, data privacy, GDPR adherence, and adoption of data stewardship principles (e.g. F.A.I.R).

Strategic Collaboration & Innovation: The jobholder is responsible for building strong collaboration and partnership with key customers and partners both internally and externally, to ensure effective safety business input to strategic activities that drive our utilisation of technologies and the integration of safety business needs into emerging cross-functional plans. The jobholder may therefore be required to participate on relevant enterprise-wide advisory bodies, and will work in particularly close collaboration with the Roche/PD Informatics, to ensure an holistic approach to supporting Roche Safety. The jobholder may also represent Roche on key external industry collaboration projects (e.g. TransCelerate initiatives) to maintain awareness, build industry level solutions and/or influence future safety-related technological innovation.

The jobholder is also responsible for building, and then providing effective line-leadership for, a small global team. Doing so in a manner that is consistent with the Roche Values and leadership capabilities. They will seek to inspire and lead their global team to create transformative solutions, and to influence their prioritisation and uptake in the wider organisation, in order to ensure that the Roche Safety Community remains at the forefront of technology exploitation and delivers its optimal contribution to the Roche Pharma Ambition. 

 

Professional and Technical Requirements:

  • University degree level qualification in a relevant discipline, typically with 10+ years of experience operating in areas relevant to clinical safety and PV, or in roles that are central to the development and implementation of technologies or digital solutions in areas/sectors that may be directly comparable to pharmaceutical R&D and/or clinical patient management and scientific decision-making.

  • Strong line-leadership experience, preferably with extensive experience of creating and leading diverse, global teams, and/or matrix leadership of enterprise-level technology-based projects in relevant areas. 

  • Broad awareness of the pharmaceutical industry and its activities, with experience of leading technology or digital-related programs or projects of relevance (e.g. programs supporting clinical safety or clinical risk management activities), in order to bring a blend of safety domain-specific expertise and technological innovation experience.

  • A relevant post-graduate qualification (e.g. MSc in Pharmacovigilance/Epidemiology; MBA; or higher degree qualification in a relevant area of Information Management or Computer/Data Science) would be desirable.

Experience, Skills, Knowledge:

  • Broad experience in the pharmaceutical industry, or experience in a comparable industry sector which requires the application of technologies or digital solutions to manage complex information at scale, in a highly regulated environment.

  • Previous experience in managing areas relevant to business technologies, digital or knowledge management solutions, or similar experience; preferably in a healthcare or clinical R&D environment.  

  • Experience working directly in PV or clinical safety roles, and/or within roles leading technology-enabled PV activities, would be a highly significant advantage.

  • Highly developed line-leadership and people influencing skills: Demonstrating a clear commitment to people development and effective mentoring: promoting a culture of trust and support.

  • Proven experience in leading collaborative technological innovation or continuous improvement efforts that have yielded tangible results and/or positive impact for patients or business stakeholders.

  • Proven ability to create and sustain strong collaborative relationships and networks with partners across a complex global organisation such as the Roche enterprise. Able to foster positive partnerships through effective influencing, negotiation and conflict management skills. Seeking to understand different perspectives and needs, gain broad stakeholder buy-in, and co-create.

  • Proven ability to integrate their work in the context of wider strategic frameworks (e.g. safety departmental or other business unit strategies; enterprise-wide digital strategies, etc) and in the context of a fast-moving and agile environment.

  • Extensive knowledge of the existing technological and digital landscape, as it relates to biopharmaceutical research, medicines development, clinical decision-making and/or patient engagement would be highly advantageous. Including hands-on expertise in relevant areas of existing technology (e.g. analytical tools, digital patient engagement solutions, AI and machine learning applications, knowledge management solutions) would also be an advantage.

  • A strong and influential communicator, with the ability to establish external partnerships with relevant partner organisations and stakeholders in the wider arena, and/or to act as an ambassador for Roche and Safety-related activities.

  • A passionate and decisive business leader. Demonstrating energy, passion, courage, vision and the drive to be at the forefront of innovative technological changes in a competitive environment, for the benefit of patients, our people and the business.

  • Demonstrable ability to work independently and influence without authority. Highly developed competencies in thinking strategically, analytically and innovatively. Able to quickly and creatively analyse situations and provide solutions to complex challenges. A critical thinker with the ability to analyse possibilities and solutions and make pragmatic trade-offs. Along with financial acumen and the ability to devise business cases and plans for senior Roche stakeholders, to manage budgets and other key resources. 

  • Knowledge of relevant regulations and standards that govern both clinical safety/PV (e.g. FDA and EU PV legislation, ICH, GCP and GVP) and relevant data/technology requirements (e.g. GDPR, etc).                

                                            

Please note that up to 25% of the time International business travel may be required depending upon the business location of the jobholder and ongoing business project activities.

This role is open in the following locations:

  • US, South San Francisco

  • Switzerland,Basel

  • UK, Welwyn

If you are proud of contributing and feel you have the commitment to teamwork and innovation that we are seeking, then Roche is the organisation for you. Every role at Roche plays a part in making a difference to patients’ lives. If you want to work in a passionate team, make your mark and improve lives, apply now. 

8/11/20 Supervisor, QC Direct Materials Manager with direct reports Vacaville, California

Summary

Supervise a team of QC Analysts responsible for the test and review of chemical and component direct materials for the Roche-Genentech network.

Job Responsibilities

  • Manage operations in a network environment as required by Roche-Genentech integration activities accounting for end-to-end business process considerations including departmental capacity, process capabilities, forecast analysis and customer requirements
  • 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.  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 personal goals for staff and provide regularly scheduled feedback throughout the year.  Ensure staff receives appropriate knowledge and skill development and growth opportunities
  • Assign activities to staff
  • Routinely monitor progress and completion of assigned staff activities
  • Notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance
  • 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
  • Follow proper safety precautions and laboratory technique in the use of reagents and other chemical compounds, including, but not limited to acetonitrile, chlorine, acids and bases, biologic toxins, microorganisms and potent compounds
  • Meet defined performance targets for the organization
  • Monitor performance and implement corrective actions, where applicable, to address adverse trends
  • Lead and/or support department strategy in support of Quality vision/strategy
  • Lead and/or participate in internal/external audits
  • Perform Trackwise assessments as appropriate
  • Perform other duties as requested by managers to support Quality activities.

Job Requirements

  • B.S./B.A. required; M.S./M.A. degree (preferably in Chemistry, Natural or Physical Science)
  • 5+ years of experience in Quality in the pharmaceutical or biopharmaceutical industry or an equivalent combination of education and experience.
  • 1-3 years of leadership experience desired, preferably leading teams, managing timelines, and prioritizing workload to meet business needs
  • Knowledge of cGMPs required
  • Ability to interpret and relate Quality standards for implementation and review

Work Environment/Physical Demands/Safety Considerations

  • Physical requirements - Prolonged periods of sitting at a laptop and/or computer desktop performing administrative activities
  • Potential exposure to chemicals while performing routine laboratory walkthroughs and/or tours
8/11/20 Procurement Specialist, HIT Individual contributor Hillsboro, Oregon

Main Purpose of the Position:

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

The responsibilities of this role include working with procurement partner to support and oversee manufacturing raw material categories.  This is a pivotal and highly visible role that engages with local operations, Genentech / Roche Global functions and extended leadership teams on a regular basis as well as colleagues from other sites and business areas both regionally and globally to implement and drive the Mission and Vision of the site and company by leveraging the procurement discipline as a business enabler.

Responsibilities:

  • Responsible for the category life cycle management.
  • Assist in the development of regional category strategies and procurement strategies through strategic sourcing methodologies in order to continuously improve total costs, service and quality for the assigned categories spend in close collaboration with the stakeholders.
  • Execute regional/global sourcing of assigned projects and develop and manage regional/global contracts to ensure uninterrupted supply.
  • Develop and implement regional/global supplier relationship management (SRM) programs for suppliers in order to improve continuously the suppliers’ performance to Roche in close collaboration with the stakeholders.
  • Ensure the execution of the projects is in compliance with the Pharma Procurement Policy Directive, Guidelines and functional SOP’s (Global Procurement Manual).
  • Is accountable for procurement targets set by the Functional Head.
  • Set, allocate and monitor project-specific targets.
  • Lead/Support Global Supplier Qualification Projects.
  • Material planning to support manufacturing operations.
  • Oversee supplier relations which includes change notifications, contract and price negotiations.
  • Implement and manage key performance indicators.
  • Manages procurement duties, including: vendor sourcing, request for quote (RFQ) preparation, purchase order terms and condition negotiation, proposal evaluations, and purchasing of cGMP and non-cGMP material, equipment, and services.
  • Researches and aids in the approval of secondary/alternate suppliers to support cGMP manufacturing.
  • Develop material forecasts based on current product bill of materials (BOM) to ensure adequate holding stock at our critical suppliers’ warehouses.
  • Aids in establishing internal inventory levels as required to support cGMP manufacturing.
  • Creates material forecasts based on current product bill of materials (BOM) to ensure adequate holding stock at our critical suppliers’ warehouses.
  • Manage non-SAP materials supply and ordering.
  • Researches purchasing trends, threats/risks to the supply chain, and develops sourcing and procurement strategies to mitigate risk to the supply chain and ensure business continuity.
  • Completes change control documentation, incident reporting, and Corrective Action Preventive Action (CAPA) process in a quality management system.

Qualifications / Requirements:

  • Bachelor’s Degree or commensurate experience preferred.
  • Minimum 5 years of professional experience within procurement.
  • Technical proficiency with appropriate procurement systems and tools (SAP experience desirable)
  • Experience in Biotech or pharmaceutical or personalized health care experience or cell and gene therapy manufacturing is desired.
  • APICS certification or other supply chain equivalent desirable.
  • Experience in LEAN Manufacturing experience a plus.
  • Ability to work independently yet collaboratively with the local and global functions.
  • Ability to setup and lead cross-functional teams and supplier relationship management teams.
  • Demonstrated negotiation and influencing skills.
  • Ability to interpret and utilize key financial data.
8/11/20 Job Title: Engineer/Senior Engineer Individual contributor South San Francisco, California

The Engineer/Senior Engineer is responsible for Engineering and Project Management of Drug Substance, Drug Product, and Facilities projects for the SSF Production. The Engineer provides leadership, mentorship, and direction to cross functional teams (Process Engineering, Automation, Validation, A&E Firms, Quality, and contractors) on execution of facility construction, equipment design, and systems qualification in a GMP environment.

Responsibilities

  • Responsible for development of business case to support CAPEX  investment. 

  • Lead Project teams thought the Genentech Engineering and Project Management processes for capital project up to 10M USD. 

  • Manage the development and implementation of novel approaches to solving complex technical problems while maintaining required levels of safety, quality (including regulatory compliance), and production and training. 

  • Present business case and engineering solutions to Finance, Plant Leadership, and operational customers. 

  • Collaborate with Regulatory to facilitate regulatory relevant changes

  • Participate in Health Authority Inspections as required.

  • Provide engineering services such system design (P&ID, FS, URS), Qualification (IQ, OQ, PQ), Qualification Protocols, Quality Controlled Change Records. 

  • Responsible for providing engineering support on a variety of production and utility equipment (including Bioreactors, chromatography columns, filtration equipment, CIP/SIP systems, parts washers, autoclaves, large scale bulk freeze / thaw tanks, component prep (vials, stoppers, etc.), filling, isolators, lyophilized, automated inspection, HVAC, Freezers, Cold Rooms, refrigeration/hot water systems, and purified water generation/distribution) 

  • Responsible for providing engineering guidance during investigations, DMS and CAPAs.

  • Mentor junior Engineers and Project Managers

  • Plan, schedule and coordinate: engineering, construction, qualification, and validation activities for GMP projects. 

Qualifications

  • B.S or higher in Chemical, Biochemical or Mechanical Engineering or a related discipline with 6+ years of relevant experience designing, starting-up, and/or operating fill / finish, or biological large molecule plant with related critical utilities in a regulated environment (i.e. pharma, food, beverage, etc.). An M.S., M.B.A. or other advanced technical or business degree is preferred.
  • Demonstrates capability to innovate and deliver business systems. 

  • Provides customer service to the diverse cGMP manufacturing customers in Drug Substance and Drug Product as well as the MSAT and quality organizations. 

  • Advanced understanding of Engineering, Project Management, Engineering Change Control and Validation

  • Knowledge of service partner organizations such as Global Engineering and QA is also highly utilized. 

  • Highly self-motivated, has excellent organization and communication skills, and is able to work independently or part of a multi-disciplinary team. 

  • Comfortable with change and be willing to establish and work towards the future vision for the organization.

  • Up to 5% Travel will be required to support equipment procurement and factory acceptance testing

  • 6+ years of GMP manufacturing experience



Work Environment/Physical Demands/Safety Considerations

  • Work in standard office environment.

  • May work in the clean room environment that requires gowning in the form of hospital scrubs, clean room gowns, gloves and steel toe boots.  

  • No makeup or jewelry can be worn when working in the cleanroom environment. 

  • May work in clean room environment or Utility spaces with large mechanical equipment, piping, and pumps connecting to tanks serviced by high-pressure steam, water and air.  Hearing protection may be required.

  • May be exposed to hazardous materials and chemicals.

Please note that this position is not eligible for relocation and only local candidates will be given consideration.

#LI-TS2

#PTeng

#PTcareers

 

8/11/20 Senior Scientist, Artificial Intelligence/Machine Learning Team Leader South San Francisco, California

Genentech is building a Center of Excellence for Artificial Intelligence/Machine Learning to accelerate discovery and development of new targets and drugs to achieve our Mission. The life sciences field has entered an era of big data. With cost-effective and high throughput genome sequencing, advanced imaging, electronically accessible data and electronic medical records, AI/ML approaches can process and interrogate data at a scale not previously imaginable. Deep learning architectures can link different data types to generate new scientific insights to accelerate science.

We seek an inspirational collaborative leader in AI/ML to lead this Center of Excellence. She/he will lead a group of AI/ML scientists working on cross-functional projects, partner with biologists, technologists and drug discoverers to develop new solutions to complex problems using diverse types of biological data.

The Role

  • You will assume a hands-on leadership role to lead a group of talented AI/ML scientists collaborating with multiple disciplines across the life sciences.
  • Conduct ML research and implement cutting edge methods for drug discovery and precision medicine.
  • Publish high quality impactful scientific articles and present at conferences, business meetings and academic institutions.
  • Deliver deep learning based software solutions for accelerating therapeutic development.
  • Develop the team's culture. Write structured, tested, readable and maintainable code.
  • Participate in code reviews to ensure code quality and distribute knowledge.

Qualifications:

  • PhD degree in a quantitative field (​e.g.​ Physics, Computer Scientist, Mathematics, Statistics)
  • 6+ years of designing and training machine learning models on large, complex and/or biased datasets (preferred: experience on biochemical data)
  • Record of scientific accomplishments supported by high quality impactful scientific publications
  • Proven ability to lead and drive high profile cross-functional projects and assignments to completion through others
  • Demonstrated experience with mathematical modeling of biological phenomena
  • Demonstrated experience with modern machine learning techniques applied to the study of biological phenomena
  • High fluency with Python and strong experience with data analysis is required
  • Fluent with at least one deep learning framework (e.g. Keras, TensorFlow, PyTorch)
  • Required: experience with the analysis of scRNA-seq data, Spatial Transcriptomics data and histopathology data
  • Preferred: experience with one additional language such as C/C++, Java, Julia, Go, Haskell or Scheme
  • Preferred: experience with probabilistic programming and related frameworks (e.g. Edward, TensorFlow-Probability, Pyro)
  • Excellent communication and collaboration skills
  • Proficiency in English, both written and verbal
8/11/20 Case Manager, Access Solutions (Contractor) - SSF Individual contributor South San Francisco, California

Relocation not provided.  Hiring Manager will consider only local hires

*Multiple positions available*

The Case Manager acts as a liaison between patients, providers, MDs, distributors and insurance carrier to assure services are provided in the least restrictive and least costly manner.

  • Provides customer focused reimbursement support to patients, pharmacists, physicians and internal sales force
  • Educates, informs, and assists patients and providers to navigate through the reimbursement process for the assigned product
  • Identifies barriers to reimbursement and continually identifies and recommends program efficiencies to the Supervisor to promote high quality of work by Access Solutions/GATCF staff
  • Identifies and facilitates referrals to alternative coverage options and financial assistance programs for patients who are under insured or require copy assistance
  • Establishes relationships with appropriate stakeholders including internal & external partners
  • May conduct necessary benefits, coverage and payer research/investigations to ensure appropriate resources, compliance with payer appeal policies, practices, timelines
  • Educates, informs and generally assists patients and their families, as well as other related external or internal parties on how to navigate the appeals process
  • This position may require some travel and flexibility in work shift.
  • Periodic mandatory overtime is required to all current and future ASO job postings for the following roles: Case Manager / Sr Case Manager

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

  • Communication – Listens well; expresses ideas fluently and logically; is open to input and can be depended on for truthfulness
  • Inspiring and Influencing – Fosters an exchange of ideas and support; persuades and influences without authority
  • Teamwork and Collaboration – Creates atmosphere of openness and truest’ collaborates; offers support and encouragement
  • Achieving Results – Is goal directed and persistent; is accountable for meeting commitments; recognizes the contributions of peers

Qualifications

  • Bachelors degree is preferred
  • A minimum of 3 years of reimbursement experience preferred
  • Proficient in all aspects of reimbursement (i.e., benefit investigations, payer reimbursement policies, regulatory and administrative rules.
  • Understands reimbursement/funding resources and how to access these resources.
  • Demonstrates effective problem solving skills and provides excellent customer service.
  • Excellent investigational and analytical skills with a proven ability to communicate effectively in both written and verbal format.
  • Ability to work collaboratively in a team structure and responsibly delegates next steps to appropriate team members.
  • Must be able to work effectively under pressure and prioritize tasks.
  • Must be able to follow written Standard Operating Procedure
  • Candidate must have excellent knowledge of the managed care industry, including government payers.

8/11/20 Reimbursement Specialist, Access Solutions (Contractor) - SSF Individual contributor South San Francisco, California

Relocation not provided.  Hiring Manager will consider only local hires

*Multiple positions available*

The Access Solutions Reimbursement Specialist investigates patient’s insurance benefits and obtains prior authorization information of Genentech products at the patient/family request.

The Reimbursement Specialist is an Individual Contributor who reports to an Access Solutions Supervisor.

Key Responsibilities/Accountabilities:

  • Investigate patient’s insurance benefits.
  • Identify network providers, provider restrictions, and co-pays as needed.
  • Document requirements for prior authorization and medical review process.
  • Document activities appropriately in progress notes.
  • Pursue product coverage for patients in accordance with the payer’s authorization requirements within the departments established performance criteria.
  • Maintain payer profiles by recording payer specific data promptly into the system.
  • Convey outcomes of benefit investigation to internal contacts (i.e. case managers).
  • Learn processes for multiple products and effectively apply learnings to provide effective reimbursement services.
  • Conduct all work in a compliant manner.
  • Consult with team members on an as needed basis.
  • Periodic mandatory overtime throughout the year is required in Access Solutions Operations. This may include, but is not limited to, high referral season (Blizzard, Enrollment renewal), new product or system launches, new line extensions, or any unexpected surge in volume or backlog situations. May include weekends as needed.

Recommended Skills and Experiences:

  • Bachelor’s degree is preferred or equivalent experience.
  • A minimum of 3 years reimbursement experience is preferred.
  • Knowledge of managed care industry including government payers.
  • Proficient in all aspects of reimbursement (i.e., benefit investigations, payer reimbursement policies, regulatory and administrative rules).
  • Understands reimbursement/funding resources and how to access these resources.
  • Excellent investigational and analytical skills with a proven ability to communicate effectively in both written and verbal format.
  • Ability to work collaboratively in a team structure and responsibly delegate next steps to appropriate team members.
  • Demonstrates effective problem solving and excellent customer service.
  • Exceptional attention to detail and ability to prioritize tasks.
  • Must be able to follow written Standard Operating Procedures.

Competencies:

  • Communication
  • Inspiring and Influencing
  • Teamwork and Collaboration
  • Achieving Results
8/10/20 Scientific Researcher, Discovery Pharmaceutics Individual contributor South San Francisco, California

We are seeking a scientific researcher to support drug discovery in the Small Molecule

Pharmaceutics Group. This position spans responsibilities from early stage research

(target identification) to late stage research (until GLP tox) in drug discovery stage. In

discovery stage, the qualified candidate will provide formulation support for preclinical in

vivo studies including PK, PD, efficacy, and tox studies. This person will also conduct

Pre-formulation work and physico-chemical characterization to support lead optimization

and selection. Additionally, experience in alternative drug delivery technology (such as

inhalation, ocular, topical, etc.) is highly valued. The successful candidate will

accomplish our mission through innovation and teamwork, creative problem-solving and

through the use of state-of-the-art technologies including but not limited to HPLC, TGA,

DSC, XRPD, DLS and DVS.

8/10/20 Early Research and Clinical Development Ophthalmology Training Program Individual contributor South San Francisco, California

This is a local hire only designated position, as relocation assistance is not available for the position 

This position is part of the Roche-Genentech Ophthalmology Connect program. It is a unique opportunity to experience drug and personalized healthcare development, and become part of the future of ophthalmology at one of the world’s leading and cutting-edge biotechnology companies.

Program Purpose: The purpose of the two-year program is to provide the opportunity to perform discovery research in the area of ocular diseases and the opportunity to gain specialized, in-depth training and experience in global drug development at Genentech, a global, research-focused healthcare company.

Role/Position: Genentech has a strong commitment to developing novel, vision-changing therapies for patients with ophthalmic diseases. We are seeking a Research/Clinical Development Ophthalmology Trainee to join the Genentech Research and Early Development (gRED) and Late-Stage Product Development (PD) organizations. 

The Research/Clinical Development Trainee will have the opportunity to perform discovery research in the area of ocular diseases. The successful candidate will implement a variety of molecular and cellular techniques to elucidate pathogenic mechanisms and identify novel targets for therapeutic intervention. This is a hands-on laboratory position with abundant opportunity for collaboration with other researchers in a highly dynamic and interdisciplinary environment. Technical as well as intellectual contributions to the team are expected.

Additionally, the Research/Clinical Development Trainee will have an opportunity to support a global ophthalmology development team.  This position will provide a unique opportunity to learn about Roche/Genentech’s Clinical Development organization that is responsible for developing and executing clinical strategies and plans to deliver novel next-generation therapies that will provide meaningful improvement to patients.  The Research/Clinical Development Trainee will join cross-functional teams responsible for the overall program strategy and design, implementation, monitoring, analysis, and reporting of studies. This will require close and frequent interactions with a number of other functions including clinical trial operations, biometrics/statistics, safety science, regulatory affairs, medical affairs, and several business and commercial functions.

Who you are: Applicants should have a relevant PhD with a strong research background in molecular and cellular biology. Postdoctoral experience required. The ideal candidate will have education and experience in retinal disease and/or neurodegenerative disease biology, as well as a basic understanding of immunology. You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.

Qualified Candidates Will Have:

  • Expertise in a wide range of molecular and cellular biology techniques, including isolation and culture of primary cells, flow cytometry, functional assay development, immunohistochemistry, Western blot, qRT-PCR, and ELISA.
  • Proficiency in iPS cells and CRISPR/Cas technologies, though not required, is a plus, as is experience with in vivo rodent models.
  • Track record of completing challenging technical problems independently and creatively, exemplified by publication of research in high-quality scientific journals is required.
8/10/20 Senior Principal Statistical Scientist Individual contributor South San Francisco, California

The Senior Principal Statistical Scientist is responsible for providing statistics expertise and strategic drug development leadership for the most complex and high impact clinical development projects, portfolio­ wide initiatives, research applications, development science applications, and/or product manufacturing applications. Their accountabilities typically extend to representing all Biometrics functions on highly visible global development teams and other cross-functional expert groups across the Pharma Development organization.

Accountabilities

Clinical Development

  • Operates at the Global Development Team level, either as Project Lead Statistician or as the sole representative for Biometrics functions on a Global Development Team.
  • Provides statistical leadership for clinical development projects, including providing strategic input into clinical development plans, target product profiles, and integrated evidence plans.
  • Directly responsible for the statistical integrity, adequacy, and accuracy of the clinical studies within the project, including activities to support personal healthcare strategy and governance committee decision making.
  • Provides analytical and strategic leadership for exploratory activities such as personalized healthcare biomarker development and PK/PD modelling.
  • May serve as lead statistician for one or more study management teams, with the incumbent responsibilities and accountabilities.
  • Leads cross-functional teams in overseeing the generation of health authority submission datasets and associated documentation.
  • Company Biostatistics lead for Health Authority interactions.
  • Oversees the deliverables from Statistical functional CROs and FSPs and provides leadership, oversight and guidance to CRO statisticians representing Biostatistics at all levels.
  • Serves as member of business development due diligence efforts.
  • Proactively advises teams and functions on overall data strategy and the best application of statistical methods including advanced analytics and relevant data types.
  • Leads and drives partnerships with other analytical functions, focusing on the application of methods that are appropriate to the data type and analysis context.

Nonclinical Statistics

  • Provides statistical leadership to nonclinical projects.
  • Directly responsible for the statistical integrity, adequacy, and accuracy of nonclinical studies.
  • Serves as expert statistical consultant for nonclinical projects and drives the development of new statistics courses.
  • Establishes new technical directions and collaborations within assigned area of focus.
  • Establishes new collaborations and technical directions to drive higher business impact.

Functional Area

  • Keeps abreast of new developments in statistics, drug development, and regulatory guidance through literature review, conference attendance, etc.
  • Leads Biostatistics and cross-functional initiatives.
  • Leads the development of functional processes.
  • Recognized expertise in clinical trials and statistical methodology for a clinical indication and/or statistical methodology for specialized applications.
  • Mentors statisticians on request.
  • May have direct reports.

Qualifications & Competencies

  • MSc or PhD in Statistics, Biostatistics, Mathematics or similar areas of academic discipline.
  • Good knowledge of English in a business environment.
  • Experience in using statistical software.
  • Expertise in applying statistical methods to patient data, including methods of advanced analytics and high dimensional data.
  • Very good knowledge of theoretical and applied statistics, including methods in advanced analytics.
  • Excellent knowledge and experience applying statistical methods to drug development.
  • Excellent understanding of regulatory guidelines in a pharmaceutical research setting.
  • Understands and applies business requirements and processes.
  • Understands and respects cultural differences when interacting with colleagues globally.
  • Largely autonomous to accomplish responsibilities.
  • Excellent Communication and Collaboration Skills (including statistical consulting skills, interpersonal skills to contribute effectively in cross-functional team settings, ability to influence others without authority, ability to build strong collaborative relationships with scientific and non-scientific partners).
  • Excellent Project management skills (including ability to manage scope and effectively delegate to other functions, staff, contractors and external vendors).
  • Excellent Strategic Agility (including problem-solving and critical thinking skills, ability to drive drug development strategies, agility that extends beyond statistical aspects).
  • Excellent Drive for Results (Demonstrates interest and ability to ·1earn new things, takes initiative, welcomes problems as challenges; finds solutions to technical problems).
  • Proficient mentoring other statisticians.
  • Demonstrated ability to lead complex teams and projects with high impact.
8/10/20 Project Manager or Sr. Project Manager, Genentech Research and Early Development Individual contributor South San Francisco, California

The Project Manager is responsible for managing projects to successful and timely decision points from Late Stage Research through Proof of Concept. This role contributes to the definition of project strategy and guides the project core and sub teams to deliver on project objectives. Additional responsibilities include the following:

  • Establish and maintain functionally integrated project schedules to enable accurate project, financial and portfolio analyses and ensure accurate inputs are provided into business planning processes. Ensure alignment with project sub-teams and functional partners.
  • Oversee and prepare project team budget including resources and costs, collaborating with Finance and other cross-functional departments.
  • Communicate, document and archive project team activities and decisions. Act as a primary contact for project team related information
  • Proactively identify and manage risks with scenario planning and risk mitigation plans.
  • Facilitate project team meetings, cross-functional communication and decision making, ensuring alignment with internal and external stakeholders.
  • Identify, recommend and implement opportunities for streamlining team and business processes.
  • Ensure the team achieves and maintains a high-level of sustainable performance by contributing to appropriate team management best practices.

Successful candidates will meet the following minimum requirements:

  • Minimum 2-4 years of multi-disciplinary experience in the biotech/pharmaceutical industry.
  • Prior direct project management experience in drug development with knowledge of the overall drug development process.
  • Experience using Project Management software to manage complex project timelines and resources.
  • Bachelor's degree in the Life Sciences. Advanced degree is desired.

At a minimum, strong candidates will demonstrate the following:

  • Strong proficiency with project management practices, tools and methodology.
  • Financial acumen with capability to plan and oversee project budgets and product valuations
  • Understanding of portfolio management concepts
  • Excellent interpersonal skills with the ability to develop important relationships with customers and key stakeholders.
  • Good conflict management skills.
  • Excellent analytical skills
  • Strong communication and presentation skills with the ability to communicate complex information effectively.
  • Ability to translate strategy into action
  • Strong influencing and negotiation skills
  • Proven track record of good decision making and exercising sound judgment
  • Embraces working in a culture where receiving and providing feedback is valued
  • Results and detail-oriented
  • Self-motivated
8/10/20 Manufacturing Technician/Sr. Manufacturing Technician - Bioprocess Individual contributor Los Angeles, California

The BioProcess Manufacturing Technician is responsible for producing innovative biotherapeutic medicine by interfacing with highly automated production systems and controls in cGMP manufacturing environment, and maintaining areas in high state of inspection preparedness. The incumbent in this role: 

  • Operates production equipment for cell culture or purification that may include culture growth, process monitoring, sampling, harvesting, purification, formulation, freeze thaw and transfer.
  • Performs media/buffer solution preparation operations. 
  • Maintains records and clean room environment to comply with regulatory requirements utilizing current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP).

Responsibilities

  • Operate systems that clean and sterilize tanks and filtration systems. 
  • Prepare solutions for the production process.
  • Review documentation and check all calculations (e.g. tickets, labels, equipment reading).
  • Troubleshoot equipment and process problems.
  • Comply with safety requirements, cGMP, SOP and manufacturing documentation.
  • Use automation to perform production operations.
  • Operate automated systems for equipment operation.
  • Assemble and prepare equipment for production.
  • Partner with coworkers and supervisor to effectively troubleshoot minor equipment and process issues.
  • Foster a positive safety culture.
  • Recognize problems, investigate and suggest potential solutions.
  • Identify deviation from accepted practices
  • Operate bioreactors, centrifuges, other harvest systems and protein purification units.
  • Operate and clean fixed tank and filtration systems
  • Operate large scale column chromatography systems.
  • Operate small-scale cell culture areas and systems by operating cleaning, set up, and maintaining 20L bioreactors; inoculating and maintaining spinner seed cultures using aseptic techniques, maintaining cell banks; and performing general seed lab operations.
  • Perform solution preparation activities (media and buffer make-up).
  • Clean, assemble, and sterilize equipment using glass washers and autoclaves.
  • Perform automated CIP and SIP of fixed equipment.

Qualifications:

The level of the position will depend on the qualifications of the selected candidate. There are multiple positions available across both Day and Night shifts.

  • High school diploma with college-level course work in biological science, physical sciences or at least 2 years of relevant experience; BA/BS in life/physical sciences or related discipline preferred.
  • Strong knowledge of at least one manufacturing department with an understanding of process impact of other areas.
  • Understanding of the theory, concepts, and regulations behind biopharma technology and processes. 
  • Good problem solving, mechanical aptitude, interpersonal communication and team skills.
  • Self-starter with strong focus on quality, details and results.
  • Effective time management and organizational skills.
  • Possess proficiency in business applications including inventory control systems. 
  • Must be able to be flexible in work assignments, work weekends, off shifts and overtime as required.  
8/10/20 Instrumentation Technician (TERM) Individual contributor South San Francisco, California

The Instrumentation Technician is responsible for the maintenance, testing, troubleshooting, calibration and repair of a variety of circuits, components, analytical equipment and instrumentation for laboratory and manufacturing equipment.

Responsibilities

  • Accountable to utilize their skills and experience to achieve the safe and accurate completion of tasks on their assigned shift in support of plant operations.
  • Timely completion of tasks and work orders with appropriate documentation according to standard operating procedures, applicable standards, guidelines, practices, and policies.
  • Safe operation of tools and shop equipment, and safe execution of work in the field.
  • Computer skill level appropriate to navigate and use corporate intranet and related applications, CMMS/CCMS, and standard word processing and spreadsheet programs.
  • Assist in the creation or modification of technical documents.
  • Ability to interact and communicate appropriately with Manufacturing, Quality, Technology, Engineering, and other departments to ensure satisfactory performance of instruments and systems.
  • Represent Maintenance Operations on multidisciplinary project teams and make presentations as required.
  • Installation, calibration, troubleshooting and modification of process control instruments or systems, laboratory instruments and analyzers, and support utilities.
  • Programming/configuration of microprocessor-based equipment (PLCs, DCS, smart devices, etc.)
  • Assistance with systems start-up and validation
  • Collection and organization of technical data from equipment manufacturers,

    equipment users, and engineering personnel.
  • Assistance with identification, purchase, and organization of spare parts.
  • Demonstrated proficiency to monitor, trend and analyze data to make corrections or recommendations.
  • Mentor colleagues in skills necessary to become proficient. Assist management in task/personnel coordination.
  • Represent Genentech during factory acceptance testing (FAT) of equipment to be supported, maintained, or calibrated.
  • Ability to read and interpret P&IDs, engineering documents and

    schematics.
  • Thorough knowledge of ISA standards and practices for

    instrumentation.
  • Thorough knowledge of the fundamental operating principles of industrial process instrumentation and systems.
  • Other tasks as needed to support Instrument Services.

Qualifications

We are seeking applicants for this position with the following skills and experience. The level of the position will depend on the qualifications of the selected candidate.

  • High School Diploma or GED and one of the following.
    • Completion of an Instrumentation or Industrial Electronics (2-year) curriculum at a technical school with 3 years experience as an instrument or electronics technician.
    • AA/AS Degree in a related science or engineering major with 3 years experience as an instrument or electronics technician.
    • Completion of equivalent military training with 3 years experience as an instrument or electronics technician.
    • 5 years in manufacturing process instrumentation and control and/or analytical instrumentation or a closely related job
  • Demonstrated knowledge of the fundamental operating principles of industrial process instrumentation and systems.
  • Knowledge of ISA standards and practices for instrumentation.
  • Familiarity with relay ladder logic and programmable controllers.
  • Practical knowledge of computer-aided manufacturing automation.
  • Ability to read and interpret engineering documents and shop schematics.
  • Effective oral and written communication skills.

Work Environment/Physical Demands/Safety Consideration

  • Ability to lift up to 50 pounds.
  • Ability to distinguish colors.
  • Working with/around various chemicals (i.e. acids and bases), solvents, pressurized systems, compressed gases, and biological materials (Recombinant DNA).
  • Work in environments that may include low, medium, or high voltages.
  • May work at elevated heights.

This position is not eligible for relocation. Only local candidates will be considered.

#LI-TS2

#PTcareers

8/10/20 Process Engineer/Manufacturing Technical Specialist - Biopharma Manufacturing Individual contributor South San Francisco, California

Genentech’s South San Francisco manufacturing facility has an opportunity available in the Process Engineering group supporting cGMP manufacturing of both clinical and commercial products. The group is responsible for monitoring, troubleshooting, and improving upstream and downstream unit operations from seed train through bulk formulation, and providing scientific and technical judgment as part of a team responsible for delivering high quality biopharmaceutical products to patients. Integrity, accountability, and strong dedication to the patients we serve are critical to this role.  

Responsibilities of this position include:

  • Adhere to all applicable compliance and safety requirements, cGMPs, SOPs, and other manufacturing documents
  • Provide manufacturing floor technical support
  • Monitor and analyze manufacturing data as necessary to provide support for process discrepancies, investigations, validation protocols, process transfers, or equipment troubleshooting
  • Analyze data and execute experiments aimed at improving process robustness/productivity or meeting the changing needs of the manufacturing environment
  • Implement engineering projects of various magnitude in order to increase levels of safety and/or compliance, improve process and equipment robustness, or increase capacity/productivity/efficiency.
  • Support product impact and root cause assessments for process discrepancies and Quality investigations
  • Support of regulatory inspections and filings
  • Create / revise standard operating procedures and manufacturing tickets
  • Provide training and technical mentorship for manufacturing operators
  • Lead cross-functional technical teams on large scale improvement and compliance related initiatives

We are seeking applicants who possess the following minimum qualifications. The position can be filled as an Engineer or Manufacturing Technical Specialist (MTS). The job family and level of the position will depend on the qualifications of the selected candidate.

  • Bachelor’s degree in Engineering, Science, or related discipline
  • 2+ years of relevant experience in industry or academia (including advanced studies); candidates with more extensive experience may be considered for a senior level.
  • Experience working in a cGMP environment
  • Experience with cell culture and/or purification process science/development strongly preferred
  • Knowledge of safety principles, quality systems, and cGMP
  • Knowledge of large scale biopharmaceutical manufacturing processes and equipment
  • Relevant work experience in a lab, pilot plant, manufacturing, or manufacturing support setting
  • Highly motivated and proactive with a track record of taking initiative to achieve business results
  • Demonstrated strong problem solving capabilities
  • Able to work independently and as part of a team
  • Strong oral and written communication skills
  • Excellent organization skills

Join our Talent Community. By joining our Talent Community, your resume will be available to our recruitment team, Join today!

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 [email protected].

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.