This position will support cell culture process development projects in the Late Stage Cell Culture Department, including characterization and validation studies. The candidate will be responsible for designing and executing lab bench-scale experiments (bioreactors, shake flasks, etc.), coordinating and supporting pilot plant experiments, analyzing data, and summarizing the results in technical documents and oral presentations. He/she will also be expected to contribute to the identification and evaluation of cell culture technology development projects and may represent cell culture on multidisciplinary project teams and task forces. He/she will be required to author internal technical, characterization and validation documents as well as deliver high quality scientific presentations to the lab group, department and externally.

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The Head of Planning  is responsible for leading and managing the PTD planning network globally, establishing a vision and mission for the group with roles and responsibilities for local and global activities, establishing and managing PTD planning business processes in close collaboration with PTDx functions, portfolio reports and interfaces with the PlanSource Steering group, ensuring resource allocation transparency. Interacts closely with PTD functional planners, PTD finance, TDLs and TDT PMs, PTD leadership team and key stakeholders within the Research and Early Development, Development and Technical Operations organizations to ensure strong partnership, excellent communication flow, resolve issues and understand inputs affecting the technical development planning activities. This position requires strong leadership, collaboration, negotiating and influencing, strategic thinking, organizational and communication skills.

MAJOR RESPONSIBILITIES

• Lead and manage the global PTD Planning  group. This includes establishing a vision and mission for the group and the global PTD planning network with clear roles and responsibilities for local and global activities, establishing and maintaining PTD planning business processes and planning operations in strong partnership with the PTD functional planners, and conduct regular alignment meeting with the PTD planner community ensuring resource allocation transparency, PTD finance, TDLs and TDT PMs, yearly maintenance of generic plans in Plansource with eRAM update, establishing training for planning functions and groups within PTD, resource planning data analysis and scenario planning to support PTD strategy initiatives. Supports budget cycle from the PlanSource perspective
• Accountable for projects and portfolio reports and portfolio analysis. This includes maintenance of reports, creation and/or retirement, and distribution of reports to meet the business needs of PTD and its stakeholders. Creates strong partnership with Global Portfolio Management aligning the PTD reporting with Corporate portfolio.
• Represents PTD on PlanSource Steering group and drives for PlanSource operational processes updates and change management within PTD.
• As a member of the PTDM leadership team, works collaboratively to establish priorities and directions for PTDM globally. Contributes to the development of department business initiatives and facilitates their implementation.
• Fosters a culture of high performance, trust and collaboration across all PTD planning stakeholders. Builds and cultivates a strong network among PTD functional planners, Finance groups, PlanSource expert groups, TDLs and strengthens partnerships to facilitate knowledge exchange and the sharing of best practices and lessons learned.  Helps to surface, analyze and resolve planning related issues and resource conflicts.
• Recruits, retains and develops talent. Establishes and implements training and development plans as required, providing constructive feedback as well. Supports the creation, use and continuous improvement of standard planning systems, tools and processes. Interacts closely with TR&D functional leaders and key stakeholders within the Research and Early Development, Development and Technical Operations organizations.

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We are seeking a collaborative individual to contribute to a team that is responsible for generating recombinant proteins by transient transfection of mammalian cells. The candidate’s primary responsibility will be high throughput transient protein production to support research and development projects. The tasks will include those associated with coordinating and performing cell culture operations (i.e. set up, inoculate, monitor, harvest and clean fermentors) as well as experiment data recording, collection and analysis. He /she will display a strong focus on collaboration, attention to detail, proficiency with multi-tasking and analytical ability. The secondary responsibility of this candidate is to optimize our transient transfection process. This includes identifying and solving technical issues, performing process development experiments, and evaluating and implementing new technology/instrumentation based on scientific literature and industry trends.  The right candidate will have experience with supervisory or management responsibilities.

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A position is available for a Scientist / Senior Engineer (E4) in the Purification Development department. The successful candidate will support the development and implementation of recombinant protein purification processes from laboratory to manufacturing scale.  This will include process optimization and product characterization as well the support of lab automation activities within the Purification Development department.  Activities will include the development of homogenization, centrifugation, chromatography & filtration operations, analytical methods such as electrophoresis and HPLC and the design and execution of high throughput experiments using robotic systems.
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The Scientist will be a member of the Protein Analytical Chemistry Validation Department (PAC-V). PAC-V is one of the seven departments that comprise Analytical Development and Quality Control  (ADQC) organization within Process Research and Development.

PAC-V  is responsible for the validation life cycle of quality control methods (covering a wide array of techniques) until established as part of a commercial control system. PAC-V is responsible for both the development and execution of the strategies. The candidate will provide practical guidance and expertise to ensure the appropriate and timely progression of acceptable validation activities across the Protein Analytical Chemistry Department.

The candidate must have in depth scientific knowledge and hands-on experience in the development, robustness testing, and validation of analytical methods, covering a wide array of analytical techniques such as HPLC, CE, MS, and wet-chemistry. He or she will be involved to ensure the proper and timely execution of all aspects of the life cycle clinical analytical methods across Genentech's clinical product portfolio and testing sites (including CMOs and partners).

Additionally, the candidate is expected to be a key player in Genentech's business process for continuous innovation to identify, evaluate, and implement novel and viable state of the art analytical technologies for QC testing. The candidate is also expected to represent PAC-V in cross functional teams. The position involves a multitude of interactions within a global matrix organization, excellent communication and presentation skills are essential.

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Job Description:

A position is available for a Scientist / Senior Engineer (E4) in the Purification Development department. The successful candidate will support the development and implementation of recombinant protein purification processes from laboratory to manufacturing scale.  This will include process optimization and product characterization as well the support of high throughput experiments and lab automation activities within the Purification Development department.  Activities will include the development of homogenization, centrifugation, chromatography & filtration operations, analytical methods such as electrophoresis and HPLC and the design and execution of high throughput experiments using robotic systems.

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An Associate Scientist position is available in the Protein Analytical Chemistry Department (within US Biologics Pharma Technical Development, PTDU).  The selected candidate will be responsible for developing, optimizing, and performing analytical methods to characterize recombinant protein therapeutics and antibody drug conjugates using techniques such as high-performance liquid chromatography (HPLC), mass spectrometry (MS), and capillary electrophoresis (CE).  This will include development, optimization and validation of analytical methods to be used for characterization and/or quality control of therapeutic protein and ADC candidates.  This individual will provide analytical support to different functional groups in PTDU and actively participate in project teams consisting of members from all areas of process development. This individual may be responsible for managing 1-2 research associates, depending on experience level.
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Conduct repetitive, predictive, condition based, reactive maintenance and troubleshooting of production equipment within the PTD Operations and Engineering group.  Assist with engineering and evaluation of existing and new equipment and processes.

Responsibilities:
• Responsible for the maintenance and repair of all mechanical process equipment within PTD Operations & Engineering at the South San Francisco facility
• Conduct general preventative maintenance according to SOPs/work instructions and perform planned and unplanned repairs as necessary.
• Conduct routine inspections and monitoring of equipment and systems.
• Perform troubleshooting of electrical, pneumatic, and mechanical equipment.
• Complete preventive maintenance and assigned paperwork in a timely manner.
• Assist/Manage specialized maintenance and equipment projects as needed.
• Responsible for inputting data to derive performance metrics for management
• Coordinate contractors and work in conjunction with internal business units who perform repairs, modifications, preventive maintenance and installations of mechanical and electrical equipment.
• Provide technical expertise and training to junior staff.
• Assist as a technical SME with identification, purchase, and organization of spare parts.
• Successfully complete training and demonstrate an ability to perform equipment monitoring and operational checks on production equipment.
• Ensure/maintain all process equipment and areas in a constant state of inspection readiness; specifically, but not limited to, the following:
o Cleanliness
o Personnel and equipment safety.
o Area maintained in an organized fashion.
• Continuously evaluate all operational Standard Operating Procedures and Preventive Maintenance procedures for accuracy and applicability.  Submit appropriate change requests to supervisor to correct any deficiencies discovered. Create new SOPs and equipment/system related procedures.
• Interact with PTD Operations and Engineering staff members as well as other internal/external customers.
• Follow established safety and environmental guidelines and procedures for all work performed. Immediately report safety and environmental incidents including injuries, illnesses, near misses, and safety suggestions. Foster a positive safety culture.
• Respond to emergency call-in when regular scheduled personnel are not available

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Reportingto the Vice President – SSF  Production, the Director of Technology willbe responsible for manufacturing science, validation, automation, recipe anddocument development and engineering functions in direct support of production.

*Provide support to operations departments in make, assess, release activities;plan and execute process related capital projects within the plant incollaboration with Corporate Engineering; work closely with GlobalManufacturing Sciences and Technology (MSAT), Process R&D, RegulatoryAffairs and Quality, representing the plant on technology transfers, regulatoryagency inspections and other issues and projects; foster innovation intechnologies, processes and systems as part of continuous improvement and cGMPefforts.
* Ensure goals, priorities, budgets and strategic plan are appropriatelyestablished and aligned.
* Ensure proper resources are available (people, materials, equipment,facilities, processes) to meet current and future goals.
* Ensure an uninterrupted supply of product in the near- and long-term.
* Ensure systems are in place to successfully complete regulatory inspections.
* Plan & manage to continuously improve safety, quality, reliability andefficiency.
* Actively promote and lead Continuous Process Improvement (CPI), Root CauseAnalysis (RCA), and risk assessment tools such as FMEA.
* Ensure qualified staff are hired, trained, developed, and recognized.
* Develop, review and approve GMP documentation and regulatory submissions.
* Work in partnership with other Genentech staff to develop and championpolicies, best practices, decisions and strategic plans.
* The incumbent will be responsible for directing, managing, and orchestratingTechnology functions within the South San Francisco Drug Substance and DrugProduct manufacturing facilities utilizing CHO and Bacterial production systems,and liquid and lyo fill lines to make commercial and clinical product.  

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Are you ready to create something that makes a real difference in people’s lives, rather than just a cool widget for the next internet startup?  What about creating tools that enable scientists and engineers to optimize cutting edge biochemical manufacturing processes that produce live-saving medicines for cancer and other unmet medical needs?

We do all of that at Genentech.  We have a small team that utilizes both agile and waterfall approaches (when it suits us) to create novel tools in a biotech manufacturing environment.  We create applications that simply do not exist in this industry – but are vitally necessary to advance the science of delivering new drugs that save lives.

We need someone to help develop and maintain applications in Perl, Ruby, ASP.NET, and some other platforms.  We do not require experience in all of these technologies, only a willingness to learn and expand your toolkit.

You will be responsible for the development and maintenance of the systems you build. You will be required to work both independently and also be part of a team. You are an excellent communicator and have a can-do attitude.

Key Responsibilities:

• Working with small teams, design, develop, test, document and implement GxP solutions based on customer requirements and translate them into functional solutions
• Provide deep technical expertise over a broad set of current technologies and platforms and mentor other team members in these technologies
• Deploy new software enhancements, troubleshoot production systems, contribute to root cause analyses and provide excellent customer service to a 24x7 manufacturing operation
• Work with a variety of in-house developed, commercial off-the-shelf (COTS) and open source software

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Your responsibilities will encompass all the activities involved in carrying out Process Development experiments with bacterial and CHO culture processes. This will include cleaning, sterilization, batching, and inoculation of bioreactors; preparing media and solutions, performing cell counts, operating harvest equipment, process and equipment troubleshooting, and experiment data recording and collection. Operate computers for process control and data entry. Partner with other shift personnel, and staff to carry out complex experiments for the development, characterization and validation of products and technologies. This job includes the improvement and creation of standard operating procedures, implementation of new technologies and equipment, participation in continuous process improvement efforts, and coordination of processes and experiments.

Skills:
The ideal candidate will display a strong focus on safety, quality, detail and results. Must be organized and capable of multitasking, have effective problem solving abilities, and demonstrated mechanical aptitude. Can proficiently perform aseptic operations with a high degree of consistency and quality. Communicates clearly, concisely and professionally in both verbal and written manners. This position requires the ability to effectively work in a team environment with diverse skills and objectives. Successful candidates must have a high level of demonstrated initiative, be self directed, exhibit flexibility in work approach, demonstrate strong follow through and accountability, and embrace positive change.

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Title: Engineer I
Job Category: Manufacturing
Department: Process and Project Engineering
Level: E2/E3
 

Responsibilities:

This position is for a Process Engineer reporting to a Manager in the Process and Project Engineering Group in the South San Francisco Production Technology Department.  The candidate will be responsible for Process Engineering and Project Management of both Drug Substance and Drug Product projects for the SSF Production Business Unit.  Primary responsibilities include supporting design, construction, startup, and upgrades to manufacturing equipment.  The candidate will provide mentorship and direction to partner MSAT groups on execution of process engineering design and project management.  The candidate will also provide Process Engineering services such as approval of P&ID changes, IQ, Material of Construction forms and ECOs on a rotating basis.  In addition, the candidate may support development of business process improvements to support efficiency.  The candidate will be hired as an Engineer I or Engineer II based on level of experience.

 

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The Demand Planner/Scheduler is the key interface between PTD Stakeholders and Operations and Engineering to build alignment of plant demand & strategy with the production capabilities and supply plans. This person collaborates cross functionally to drive predictable demand for drug substance and drug product to ensure clear requirements for supply planning.

Our goal is to provide unsurpassed customer service within our organization and partners.  As a member of the Supply Chain Management team, Support Services Process Technical Development, you will be responsible for the following tasks:
• Develop, manage, communicate, and plan effectively to ensure alignment with, and clear understanding of strategic and operational goals of our customers.
• Ensure alignment between mid-term and long term plans
• Drive, monitor and ensure achievement of plant key performance metrics
• Review plant performance and agree upon planning parameters for the upcoming cycle
• Participate in projects that are aligned with our business strategy and technology roadmaps
• Provide input into strategic functions for sourcing and/ or investment decisions
• Act as a Single Point of Contact for our customers for relevant Demand Planning topics (Targets / Key Performance Indicators / Service Level Agreements)
• Collaborate on product forecasting process management, identification and management of strategies to manage demand variability and forecast accuracy
• Continuously analyze the forecast, review, check for imbalances and monitor alerts
• Help articulate and communicate demand uncertainties and risks and develop options for optimizing Inventory, replenishment and demand plans to supply planning
• Responsible for defining the suitable planning constraints jointly with team and is accountable that the agreed constraints are implemented
• Responsible to monitor plan stability and drive continuous improvement to targets
• Responsible for managing key parameters / key performance indicators / targets, used in all areas of operations
• Responsible to present on status and issues of plant metrics and escalating risks to management according to defined thresholds

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The Position

• Perform final review, cumulative review and disposition of Genentech manufactured cell banks and clinical drug substance, drug product and final drug product.
• Review and approve procedures, tickets and other clinical QA controlled documentation. 
• Provide clinical trial support such as COA/COC/COT requests.
• Provide support and oversight of manufacturing activities on the floor.
• Manage batch disposition activities to ensure that products are dispositioned in accordance with cGMPs, Regulatory, and Genentech Policies and Procedures and adherence to schedule.  
• Set personal performance goals and collaborate with management to establish organizational objectives.  
• Manage competing priorities to meet department and organizational targets and timelines.
• Serve as the Quality representative on cross-functional and multi-site teams.
• Identify, design, and implement process and system improvements.
• Apply advanced theory, technical principles, and judgment to address a broad range of difficult problems.
• Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance
• Be accountable for behaviors as described in Genentech's Core, Common, and Critical Competencies.
• Perform any other tasks as requested by Management to support Quality oversight activities.
• Interface with appropriate departments to ensure that batch disposition items are complete and timely notification to Management of all known delays and significant Quality issues is provided
• Interact with interdepartmental contacts on discrepancy assessment, resolution, and Quality approval
• Support and present in Internal and Regulatory Inspections.
• Participate in the resolution of Quality issues by fostering effective interdepartmental and cross-functional relationships.
• Participate or lead different internal or cross functional projects relevant to QA lot disposition
• Train new personnel and internal customers on relevant business processes.
• Ability to revise or create work instructions, SOPs and business process instructions.

 

 

 

 

 

 

 

 

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Lead the development of pharmaceutical manufacturing processes or technologies on bench & pilot scale and implementation on a manufacturing scale.  Collaborate across multiple functional areas such as formulation development, manufacturing and validation.  Utilize advanced engineering principles, concepts and techniques to solve technical problems in the following areas of focus:  storage / handling of protein bulks, freezing, thawing, mixing, sterile filtration, filling, pre-filled syringes, microencapsulation, lyophilization, vial inspection and vaporized hydrogen peroxide. Support or lead technical projects and on-going manufacturing operations including technical transfers between sites and performing trouble shooting activities. Managerial responsibilities commensurate with experience....

Lead the development of pharmaceutical manufacturing processes or technologies on bench & pilot scale and implementation on a manufacturing scale. Collaborate across multiple functional areas such as formulation development, manufacturing and validation. Utilize advanced engineering principles, concepts and techniques to solve technical problems in the following areas of focus: storage / handling of protein bulks, freezing, thawing, mixing, sterile filtration, filling, pre-filled syringes, microencapsulation, lyophilization, vial inspection and/or terminal sterilization by radiation, vaporized hydrogen peroxide, or other gases. Support or lead technical projects and on-going manufacturing operations including technical transfers between sites and performing trouble shooting activities. Managerial responsibilities commensurate with experience.

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This position involves work as part of a multi-disciplinary team that is exploring strategies to understand and enhance the ocular pharmacokinetic properties of therapeutic antibodies. Responsibilities will include the design and production of protein variants, purification of proteins for animal studies, and analytical characterization for target affinity and stability.  The successful candidate will actively participate in project teams and make intellectual contributions to the research. Assistance in the preparation of written technical reports, and submission of external publications and patent applications when appropriate, is expected....

• The successful candidatewill be responsible for the design, development and implementation of delivery devicesfor parenteral pharmaceutical therapeutics.  Primary technologies in-scope of the role includemanual injection systems, automated injection systems, and interfaces withpre-filled syringes and cartridges.
• Major responsibilitieswill include the development and commercialization of devices includinginterfaces with the primary container.
• This person will be atechnical expert and will provide technical leadership in the development andcommercialization of new drug-device combination products in collaboration withRoche and Genentech's engineering, scientific, and manufacturing organizations.
• He/she will provideguidance and input regarding product development and will regularly interfacewith staff and leaders in Commercial Marketing, Clinical Sciences, ContractManufacturing, Product Core Teams, Pharmaceutical Development, PackagingDevelopment, Quality and Regulatory Affairs.
• He/she will also regularlyinteract with external development partners and component suppliers, and may alsosupervise staff members.

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A post-doctoral research fellow position isavailable in the Late Stage Pharmaceutical Development group to investigate thetemperature and concentration dependence of protein interactions in solutionand cryogenic conditions. Many monoclonal antibody (MAb) products are developedas high concentration solutions, and have been observed to present a range ofissues (aggregation, precipitation, phase separation) on storage. Thetemperature dependence of intermolecular interactions between proteins andother solution components remains poorly understood, in particular in cyro-concentratedconditions. The objective of the post-doctoral research fellow will be to characterizethe temperature dependent interactions of antibodies in both liquid and frozen glassystates, using a variety of biophysical techniques and novel experimentalapproaches to gain understanding of the underlying molecular basis of theprotein and solvent interactions that result in a variety of bulk solutionbehaviors.

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Our group is searching for an experienced and dynamic Device Development/Product Introduction Engineer to be responsible for design for manufacturability, assembly, testing, and the interaction between product design and manufacturing process development of parenteral drug delivery devices.   This includes design, testing and transfer to production activities for a wide range of combination products, along with providing technical support to partners working on validation, quality and program management.

We are looking for a candidate that has the ability to affect change, deal with uncertainty and deliver to commitment in high quality manner.  The environment is challenging, results oriented, and rewarding with opportunities for impact.


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