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

...

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.  

...

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

...

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.

 

...

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

...

Position description and responsibilities:

A position is available in the Protein Analytical Chemistry department for a Scientist with appropriate analytical skills and biopharmaceutical industry experience. The candidate must have strong understanding and hands-on experience in analytical characterization of recombinant therapeutic proteins, development of quality control methods, and application of emerging analytical technologies. The candidate should have experience in or be highly familiar with the development of analytical methods covering a wide array of techniques such as HPLC, CE and mass spectrometry. The Scientist will design and execute analytical characterization studies to identify critical quality attributes for each product. A strong understanding and knowledge in analytical control strategy development and cGMP is highly desirable.

The Protein Analytical Chemistry department is part of Genentech's Pharma Technical Development Biologics organization and is responsible for method development and detailed structural characterization of recombinant proteins to support the clinical and commercial biotechnology product portfolio.

...

Purpose:

Accountable for the deployment andrealization of the Quality and Compliance strategy for PharmaGlobal Technical Operations (PT) External Quality Operations CMO - Biologics.

Key Responsibilities:

• Directaccountability for Quality and Complianceactivities and organization across PT’s external CMOsfor Biologics
• Leadingdeployment and full realization of the PT QualitySystem requirements through Quality Agreements and Contract  Quality Requirements  with externalCMOs.
• Ensurean objective, proactive cGMPcompliance program is established andoperational.
• Qualityresponsibility for extention ofmanufacturing network into EM (India, Russia, Brazil) and forDevices
• Product qualitymanagement activities
• End-to-end externalCMO - wide Quality Risk management
• Directcontinuous improvement activities ofexternal CMOs toimprove Quality and Compliance performance.
• Sponsor forthe Global Quality external CMO issues management process and system.
• Directlyresponsible for External Quality Operations CMO organization
• Overall budgetand financial performance for External Quality Operations CMO organization.
• Accountablefor demonstrating and realizing Roche’score values and expected behaviors.

...

A Research Associate/Senior Research Associate 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).  The individual will maintain excellent documentation of all work including laboratory notebooks, test methods, or any other appropriate documents.  Additionally, the individual will be responsible for presenting results and experimental information to departmental colleagues, writing and reviewing internal reports, and representing the department on project teams consisting of members from all areas of process development.
...

• Responsible for maintenance, calibration and replacement of equipment in the department (HPLCs, AKTAs, spectrophotometers, lab supplies, etc.), maintenance of laboratory clean up schedules, and documentation systems.
• Work with your manager to prioritize tasks and assignments and make recommendations to maximize efficiency and productivity based on department needs.
• Support the department by maintaining inventory of supplies and buffers.
• Increase the efficiency and effectiveness of the department by using 5S principles to facilitate our daily operations. 
• Act as a single point of contact for resolving laboratory and facility related issues in a fast-paced environment with tight timelines.
• Work with a large group of researchers as well as outside partner groups and vendors to ensure optimal use of laboratory facilities.
• May assist co-workers with purification studies

 

 

...

A position is available in the Protein Analytical Chemistry department for a Scientist with relevant analytical skills related to the biopharmaceutical industry. The candidate must have strong knowledge and hands-on experience in analytical characterization of recombinant therapeutic proteins, development and validation of quality control methods, and application of emerging analytical technologies. The candidate should have experience in or be highly familiar with the development of analytical methods covering a wide array of techniques such as HPLC, capillary electrophoresis (CE) and mass spectrometry. The Scientist will design and execute analytical characterization studies to identify critical quality attributes and enable a commercial control system for a late stage product. A strong understanding and knowledge in analytical control strategy development and cGMP is highly desirable.

The Protein Analytical Chemistry department is part of Genentech's Pharma Technical Development Biologics organization and is responsible for method development and detailed structural characterization of recombinant proteins to support the clinical and commercial biotechnology product portfolio.

...

Main Purpose of the Position:
• Direct staff and operations to manage and support multi-site investigations and CAPAs.
• Provide leadership and guidance to staff performing multi-site investigations and CAPA activities for the Biologics OU.
• Establish strategic goals and objectives to achieve department and company
• Manage performance and development of direct reports to ensure achievement of organizational and department goals and a productive environment.

Job Duties/Responsibilities:
• Manage and administer all aspects of people processes related to the employee life cycle.  This includes the selection, hiring and training of personnel on company and department policies, systems and processes.  Manage and communicate compensation related information per company guidelines.
• Coach and develop staff by providing an environment that encourages ongoing personal and professional growth.  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.
• Interpret, execute and recommend improvements to Quality operational policies, plans and procedures.
• Provide input to department budget and monitor and control expenditures against the department budget.
• Provide input for the development of overall Quality objectives and long-range goals.
• Notify Senior Management of potential quality or regulatory issues that may impact product quality or regulatory compliance.
• Lead and participate in continuous improvement initiatives for Genentech Quality Systems.
• Sign documents for activities as authorized and described by Genentech policies, procedures and job descriptions.
• Be accountable for behaviors described in the Roche Leadership capabilities.
• Perform any other tasks as requested by Senior Management to support Quality oversight activities.

Technical Duties/Responsibilities:
• Lead a team to manage and support multi-site Biologic investigations and CAPA.
• Support the development and manage the implementation of the Investigator Certification program.
• Sponsor and provide guidance for multi-site investigations and CAPA activities.
• Participate in the Quality review Board
• Develop and report metrics that focus on continuous improvement and ensure an effective and compliant investigation system.
• Partner with Site Quality Heads and other PT groups to with interdepartmental contacts on investigation assessment, resolution, and quality approval.
• Approve Quality Investigation.
• Perform timely escalation to Sr. Management of quality issues potentially impacting products, materials or processes
• Support sites during root cause analysis
• Lead Investigation and CAPA continuous improvement efforts
• Develop short-term goals and long-range plans to ensure effective utilization of Quality resources to support  
• Act as an advisor to internal project teams by providing extensive knowledge of regulatory requirements, industry standards, and company strategy. 
• Provide technical and quality assurance input during the review and approval of applicable documents. 
• Participate in the Quality Review Board.
• Manage the end-to-end investigation process
• Identify, facilitate and establish cross-site and cross-business unit processes to ensure efficient and timely investigation strategies.
• Ensure appropriate application and integration of cGMPs into the discrepancy management system.
• Educate departments on the best practices for conducting investigations and root cause analysis.
• Collaborate with departments to ensure process improvement proposals are practical and feasible.

...

Description
The Critical Reagents System (CritRS) in Purification Development is responsible for the purification of critical reagents in support of assay development (for clinical products), assays in support of regulatory filings, the continued support of assays for marketed products, as well as specific reagents that support general test procedures (such as ELISAs to measure host cell impurities).  The candidate will be responsible for protein purification, characterization, and documentation of critical reagent production within the purification group. The work also includes interaction and collaboration with members of other CritRS production and customer groups, and potential support of other projects within the group.

...

You will be responsible for a wide range of administrative duties supporting the head of Global Technical Development, as well as the global PTD leadership team and the broader PTD organization.  As leader of the PTD administrative team, you will handle a wide variety of coordination activities to ensure a productive team environment and culture across PTD .   As part of the senior leadership administrative staff at GNE and of the PTLT, you be responsible for working collaboratively across organizational boundaries to support GNE and PTLT leadership.  You will deal with confidential and time sensitive material in a fast paced, dynamic, global setting. Your experience and mature judgment will be essential in planning and executing projects, planning offsites, townhalls, celebrations, and other activities helping to create a great place to work.  You will represent the PTD organization.  You will provide a key partnership to the Head of PTD and contribute to her effectiveness through your ability to multitask, organize, plan, engage, and prioritize with minimal direct supervision.

Administrative support includes:

• Managing electronic calendar, scheduling & global meeting management including coordination of telepresence, videoconference, teleconference meetings and meeting materials
• Creating, editing presentations, spreadsheets and word documents, proofreading and compilation of special reports.
• Handling correspondence and shared electronic filing system
• Making extensive international travel arrangements.
• Preparing expense reports.
• Initiating and managing purchase orders and contract processes including PO, invoices and payment tracking.
• Arranging various recruiting activities such as on-site interviews.
• Coordinating meeting and conference arrangements, planning off-site, town hall meetings, and organizing catering
• Leading the PTD administrative team meetings to ensure alignment, awareness of new business processes, and create a sense of community. 
• Delegating various departmental administrative responsibilities and supporting the growth and development of the PTD administrative team.

...

Position Description and Responsibilities:

A Research Associate/Senior Research Associate 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).  The individual will maintain excellent documentation of all work including laboratory notebooks, test methods, or any other appropriate documents.  Additionally, the individual will be responsible for presenting results and experimental information to departmental colleagues, writing and reviewing internal reports, and representing the department on project teams consisting of members from all areas of process development.

...

A Scientist position is available in Protein Analytical Chemistry (within US Biologics Pharma Technical Development, PTDU).  Responsibilities will include analytical characterization of recombinant proteins – primarily monoclonal antibodies 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 candidates.  The 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. The individual may be responsible for managing 1-2 research associates, depending on experience level....

The candidate will support the development and implementation of recombinant protein purification processes from laboratory to manufacturing scale. The work will include purification process development, optimization, characterization, and validation as well as technology development. The work includes projects carried out at laboratory, pilot plant, and industrial scale using separation unit operations including column chromatography, filtration, and centrifugation....

The candidate will support the development and implementation of recombinant protein purification processes from laboratory to manufacturing scale. The work will include purification process development, optimization, characterization, and validation as well as technology development. The work includes projects carried out at laboratory, pilot plant, and industrial scale using separation unit operations including column chromatography, filtration, and centrifugation....

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.

...

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.

...