• Lead and/or participate in tech transfers of purification processes across Roche/Genentech’s drug substance manufacturing facilities and to external contract manufacturing facilities.  Requires close collaboration with cross-functional team to implement, validate, and license Drug Substance processes at receiving sites.
• Responsible for providing on-going technical support for Drug Substance production at contract and partner sites. Includes monitoring process performance, resolving manufacturing deviations, participating in quality investigations, and providing technical approval of document and automation recipe changes to support continuous process improvement.
• Lead and/or participate in global initiatives and cross-functional teams in the areas of downstream processing.
• Work collaboratively with site Manufacturing Science and Technology (MSAT) groups to develop and communicate best practices for process design and operations to ensure consistency and compliance across the biologics manufacturing network.
• Represent MSAT Network on corporate initiatives led by partner groups such as Quality, Regulatory, Manufacturing Operations, Pharma Technical Development, etc.
• Provide technical leadership for topics including support for proposed manufacturing process changes, process validation, discrepancy and investigation evaluations, change control, and regulatory submissions. Some lab work may be required in order to resolve investigations and/or demonstrate proof-of-concept for proposed process changes.
• Responsible for authoring and reviewing technical reports, manufacturing instructions, process validation documents, and portions of regulatory submissions to support licensing processes at new manufacturing sites.
• Travel within the Roche network and to contract manufacturing sites will be required.

 

 

 

...

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.

 

 

 

 

 

 

 

 

...

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.

...

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.

...

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.

...

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.


...

The successful candidate will be able to lead a cross functional team, and direct the design, development and implementation of a new generation injection device.  The candidate will work with his team to ensure that device design, component selection, container-device compatibility, manufacturability and test methods meet the product needs. This person will regularly interface with staff and leaders in Device Development, Project Core Teams, Early and Late Stage Pharmaceutical Development, Quality and Regulatory Affairs. He/she will also regularly interact with external development partners and component suppliers. He/she may also supervise 2-3 staff. In addition He/She will drive problem solving activities using state of the art tool such as DMAIC, DFFS, DOE, Modelization, Monte Carlo Simulation, Probabilistic Design.


...

• Provide QA oversight, support and execution of validation/qualification activities pertaining to Investigational Medicinal Products (IMP, a.k.a. clinical) GMP manufacturing equipment and analytical instruments, including preventive maintenance and requalification activities.
• Provide technical review and approve quality risk management and validation/ qualification deliverables for small molecules and biologics equipment qualification, ensuring proper design and execution.
• Ensure that equipment and systems remain in a validated state, and that validation master plans and their related documents are accurate and current.
• Develop strategies and act as project manager for new projects in collaboration with system owners.
• Develop near-term and long-range plans for the department in collaboration with Senior Management.
• Provide technical assessment and approval for GMP changes.
• Assess equipment-related discrepancies and provide input to investigations.
• Apply expertise of compliance requirements to maintain an inspection-ready state.
• Participate in audit/inspections as a subject matter expert.
• Support implementation and provide stakeholder feedback and input to the integrated Pharmaceutical Quality System (PQS) documents.
• Perform tasks and work to achieve company goals and organizational objectives.
• Serve as the Quality representative on cross-functional and multi-site teams.
• Provide guidance to internal and external customers on best practices for generating and executing validation protocols.
• Provide input into investigations involving GMP related failures.
• Develop and implement process and system improvements, including contributing to the development of new concepts, techniques and standards.
• Advise other IMP QEV staff members on Validation related processes and projects.
• Supervise/oversee temporary or contract staff, as required.

...

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.

 

 

 

 

 

 

 

 

...

The incumbent in this position willbe responsible for managing Device Development Quality areas includingdevelopment of Design Controls and associated documentation, documentationcontrol system implementation, as well as coordinating educational forums for projectteams. Quality System areas of accountability include Risk Management, DesignHistory Files, and other aspects of Design Controls. With respect to DesignControls, responsibilities include participation in cross-functional initiativesto develop, influence and globally align the Design Control strategy whileensuring consistent practices are adopted and followed. The incumbent will alsoserve as the primary liaison / spokesperson between Quality and the DeviceDevelopment Leadership team. He/she will work with Device Teams to create,oversee maintenance and continuously improve Design Control processes forteams, and drive consistency in approach and documentation content across thepipeline portfolio to streamline development. Regular interaction with DeviceTeam Leaders is required. The position requires working with teams to developand implement Risk Management plans and Design History Files ensure theapproach is consistently applied across projects. The incumbent will supportinternal and external audits of the department, and is accountable for ensuringthat the department is in compliance with regulatory requirements forcombination products. The incumbent will regularly interface with thosefunctions contributing to execution of the Device Strategy including but notlimited to Clinical, Development, Manufacturing Collaborations, Quality andRegulatory Affairs.  The incumbent willalso support the continuous improvement of business processes related tocombination product development and commercialization, providing linkagesbetween the Design Controls and device business processes. The incumbent willalso serve as a departmental representative for commenting on global regulatoryauthority draft guidance and proposed rules.

 

...

Responsibilities      

• Perform technical and compliance review of analytical testing results for bulk, final product, pre-clinical, cell banking and stability products
• Compile analytical data for bulk, final product, pre-clinical, cell banking and stability products
• Set up stability studies for clinical products in accordance internal PQS and ICH stability guidelines. 
• Plan and prioritize new stability studies to ensure regulatory submission timelines are met.
• Review and approve time point data to ensure regulatory compliance.
• Manage inventory of all stability studies, including sample submission to partner labs and cycle counting
• Assess and approve discrepancies of clinical and pre-clinical products
• Technical proficiency in analytical methodology and adherence to cGMP compliance
• Train colleagues on stability, assay review and analytical methodology as appropriate
• Identify and address gaps in systems and procedures for continuous improvements.
• Accomplish corporate, operational and departmental goals
• Exert influence in the development of objectives and long range goals of the organization
• Make independent decisions around complex issues in alignment with Roche policies
• Support internal and external audits
• Work with internal departments and outside vendors, collaborators and partners concerning projects and commitments
• Mentor and supervise (as required) other staff members on QC related, processes and projects.

...

Responsibilities      

• Perform Quality review and approval of method validation and qualification reports
• Perform technical and compliance review of analytical testing results for bulk, final product, pre-clinical, cell banking and stability products
• Compile analytical data for bulk, final product, pre-clinical, cell banking and stability products
• Assess and approve discrepancies of clinical and pre-clinical products
• Review and approve COA, COT and stability statements
• Technical proficiency in analytical methodology and adherence to cGMP compliance
• Train colleagues on assay review and analytical methodology as appropriate
• Identify and implement process improvements
• Accomplish corporate, operational and departmental goals
• Exert influence in the development of objectives and long range goals of the organization
• Make independent decisions around complex issues in alignment with Roche policies
• Support internal and external audits
• Work with internal departments and outside vendors, collaborators and partners concerning projects and commitments
• Meets scheduled performance of 95% on-time
• Mentor and supervise (as required) other staff members on QC related, processes and projects.

...

The intern will work in the global Packaging Development group, supporting the Distribution Technology team by characterizing the mechanical properties of different materials used for packaging in the Roche network. The intern will also be using the information gathered in the laboratory to model those materials in silico, and to identify attributes critical to performance. This will help the Packaging Development group by optimizing the final package design proposed while accelerating development and qualification activities. A final report and presentation are expected at the end of the internship.

The intern will learn how to use multiple test equipment including but not limited to Universal (push and pull) test machines, compression, shock, drop and vibration machines, as well as measurement devices. The intern will also learn how to use software for documenting laboratory results, 3D modeling software and effect modeling software. Finally, the intern will get the opportunity to learn about and support other projects in Packaging Development.

...

  The Product Quality – Biologics group is part of IMP QA.  The department is responsible for the product quality for biologics and antibody-drug-conjugates in the global Roche network throughout the development lifecycle to commercialization.  As a member of the IMP Product Quality group, the Sr. Quality Product Leader serves as the single point of contact on the technical development teams and is accountable for driving the quality activities for the teams.  This position must effectively communicate timelines and issues to Quality to ensure successful manufacturing, product testing/release and regulatory filings.    Additionally the position must partner with other organizations throughout Roche Global Pharma Technical Operations, including but not limited to: QA Operations, Commercial Quality, External Quality, Pharma Technical Development (PTD), and Regulatory (PTR).  This position will primarily support project activities during late stage development and the process handover from development to commercial as part of new product commercialization.

Responsibilities
•Participate in regular technical development team meetings and provide clear and timely feedback to the teams.•Communicate timelines and issues to all relevant Quality departments in a timely manner.
•Engage and collaborate with partner groups (e.g., within and outside Quality, external partners, etc.) and across global sites in the Roche network to ensure production, testing and release, and regulatory submission timelines are achieved without compromising product quality. 
•Proactively work with technical development teams, commercial counterparts, and senior management to identify and escalate project quality risks with the goal of delivering a robust process appropriate for commercial filing acceptable to Health Authorities and provides reliable products after launch
•Provide high level oversight of PC/PV, method validation and transfer activities during commercial filing preparation, and ensure timely escalation of timeline bottlenecks to senior management
•Lead Quality investigations, including developing proposals for resolution of product-impacting Quality issues and presentation for endorsement to Quality Review Boards, and oversight of outcome of appropriate CAPA’s associated with product-impacting investigations.

...

An Associate Scientist position is available within the Late Stage Pharmaceutical Development Department.  The primary responsibility will be leading particle identification and analytical characterization efforts to support pharmaceutical development.   These activities include the development and implementation of novel analytical methods, physical-chemical characterization of particles including compositional analysis, and root cause analyses in support of product investigations. The candidate is expected to participate in cross-functional product development teams and work closely with other technical groups including analytical chemistry, protein purification, quality, and regulatory.  Further, the candidate is expected to develop scientific independence and exhibit creativity by identification and evaluation of new scientific opportunities that further the current state-of-the-art....

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....

• Partner with Device Team Leader to define and execute Device strategy in alignment with Technical Development (TDT) & Lifecycle Team (LCT)  strategies.  Develop realistic project plan/schedule and track Team’s progress in meeting milestones and deliverables.  Facilitate Device team meetings in partnership with Device Team Leader to drive sharing of information, decision-making, issues resolution , risk mitigation and team member engagement
• Ensure Device Team plan is integrated with Technical Development Team plan and aligns with overall LCT strategy
• Define and oversee the Device Team project milestones and key deliverables:
• Analyze & understand the critical path activities ensuring Team members are aware of interdependencies
• Drive flow of information across Team members and relevant key stakeholders to facilitate awareness of Team’s efforts and efficient decision-making
• Escalate unexpected events impacting project schedule, budget & resources to management
• Provide regular project updates to management on project status including risk mitigation plan.
• Monitor resource and project variable costs needed to execute Device Plan and work closely with TDT PM to ensure budget is integrated with TDT plan in PlanSource
• Support relevant design control activities outlined in standard and assist with drafting, compilation and tracking of Design Control Documentation as required.
• Support efforts business process improvement efforts including but not limited to updating business process content, implementing tools & best practices and driving awareness across Teams. 
• Maintain knowledge of system performance at sites and business units, through familiarity with local SOPs, frequent interactions with local system owners, and established performance metrics.
• Be accountable for behaviors described in Genentech’s Core, Common and Critical Competencies.

...

This position involves research, development and commercialization of technology for sustained delivery of therapeutic proteins.  The successful candidate will work as part of a multi-disciplinary team evaluating strategies for improved treatment options for ocular disease.  Responsibilities will include the design and execution of in vitro release experiments, evaluation of drug compatibility with formulation and device components, and research on mechanisms of drug release.  Effective utilization of technical staff to support these functions is required.  Projects may also include molecule engineering to enhance delivery effectiveness. Oral presentations to review bodies, preparation of written technical reports, and submission of external publications and patent applications when appropriate, are expected....