The Senior Scientist, in vivo pharmacology, will lead a translational research group focused on immune-mediated oncology therapeutics. The successful candidate will work closely with other disciplines within Genentech to drive research stage programs into early clinical development, providing scientific and strategic leadership, and technical management. The individual must be motivated to work in a scientifically rigorous, fast-paced environment to achieve key results that drive program decision-making. The ideal candidate will have an in-depth understanding of immunology, cancer biology and animal models with a strong publication record.

Summary of Key Responsibilities:

• Lead translational research group primarily supporting tumor immunotherapy programs.
• Develop experimental strategies to define/validate the mechanism of action and mechanism of resistance of immune-mediated anti-tumor therapeutics.
• Provide in vivo pharmacology expertise to project teams during the discovery and development phases of biologics and small molecule drug discovery programs.
• Define PK/PD/efficacy relationships in collaboration with colleagues within DMPK and research oncology.
• Develop innovative preclinical animal models that enable interrogation of mechanisms of action, diagnostic hypotheses, and mechanisms of resistance.
• Direct management of up to 5 research associates, in vivo and in vitro. Develop and assess goals of direct reports.
• Responsible for authoring documents to support regulatory filings and patent applications.

• Development of new in vivo models of autoimmune, inflammatory, and infectious diseases that reproduce significant aspects of human pathophysiology, as reflected, in part, by response to human standard of care therapeutics or their surrogates.
• Generation of new assays in preclinical species to ascertain and understand PKPD relationships of specific new molecular entities (NME), as well for the performance of efficacy experiments with NMEs in appropriate models.
• Interaction with discovery laboratories in which the NMEs are generated in order to design and execute appropriate experiments to characterize the NMEs and their effects, as well as to develop technologies required for the pursuit of the scientific objectives of the discovery laboratories and of Translational Immunology.
• Translational Immunology representation on NME teams. These roles will be performed both in his/her own laboratory and by oversight of three additional laboratories.

• 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

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.

Objectives and Scope of Position:

• Responsible for the preparation of regulatory documents for submission to regulatory authorities within subject area (clinical/safety). This role involves working in close partnership with the medical/scientific content owners in the relevant functions
• Takes accountability for delivering regulatory documents and works effectively and closely with key content owners 
• Applies document and project management expertise
• Contributes to the functional excellence of regulatory documentation (process management) 

Primary Responsibilities and Accountabilities

• Prepare regulatory documents in accordance with applicable regulatory guidelines/Roche standards/SOPs, ensuring high scientific quality & consistency with other documents where appropriate
• Liaise with document contributors to gather information (including Licensing partners where relevant)
• Plan & create timelines for the production and review of documents ensuring alignment with overall project timelines where appropriate
• Review documents for: organisation/clarity/use of English language/grammar/scientific standards/consistency between textual presentations and listings/tabular or graphical displays 
• Manage the review process, including leading/coordinating adjudication of review comments and incorporating review comments
• Participate as a member of key functional/cross functional Team (s) (e.g. Regulatory Area Functional Team, Safety Team etc), ensuring that Teams adequately plan for document deliverables
• Ensure that the document is published in collaboration with Regulatory Operations and that the document is approved by the single accountable signatory

In addition as a Senior Regulatory Documentation Scientist

• Manage the preparation of a suite of regulatory documents e.g. Clinical Dossier, suite of Safety Documents
• Lead Writing Team for preparation of Clinical Dossiers/Safety Reports
• Review documents to ensure adherence to documentation quality standard, regulatory requirements and consistency of messages across all documents for a product/across clinical documents within a dossier
• Prepare specifications for outsourced work (writing/review of documents) and serves as Roche liaison for project purposes
• Plans and creates timelines for the production of assigned documents e.g. Clinical Dossier/Suite of Safety documents. Ensures proper planning and resourcing of all documents assigned to Writing Team including what work or portions of work to be outsourced
• Actively contributes to best practices and continuous improvement within Regulatory Documentation. Represents the group in functional and cross functional initiatives/projects when required

The candidate will be a member of the Analytical Chemistry group in the Method Management and Technology (MMTech) Function within Genentech’s Corporate Quality Organization.  MMTech is the scientific and technical Center of Excellence for commercial quality control methods, specifications/control systems and reference standard and provides support to the Roche/Genentech Global Quality Control Network for the commercial biotech product portfolio. We are looking for an experienced Scientist to play an integral part in providing and supporting analytical chemistry methods (e.g. HPLC, CE) used for quality control purposes.

MAIN PURPOSE OF THE POSITION

• Responsible for method troubleshooting and optimization in support of life-cycle management of methods for Roche/Genentech commercial biotech products
• Develop and execute experiments for the development, validation, implementation of QC test methods for commercial biologic products following cGMP regulations, regulatory guidelines as well as local and global quality standards.
• Support regulatory submission and inspections: through authorship of CMC subsections, responses to questions and direct interactions

JOB DUTIES/RESPONSIBILITIES

• Serve as analytical technical lead/representative (biotech products) on cross-functional and multi-site project teams.
• Ensure on-time delivery of controlled documents, reports and method packages to support project timelines.
• Apply technical knowledge, scientific experience and expert judgment to address a broad range of difficult problems.
• Troubleshoot and direct the resolution of QC method issues by fostering effective interdepartmental and cross-functional partnerships.
• Serve as a technical subject matter expert (SME) in support of departmental functions.
• Perform assigned tasks and work to achieve company goals and department objectives.
• Train personnel and internal customers on relevant business processes.
• Support the development and administration of Quality Control and laboratory training materials.

Main Purpose of the Position:   
• Manage and develop solutions to complex global QC change control issues and Quality initiatives with inter-organizational and multi-site impact across the Biologics network following cGMP regulations and Roche standards. 
• Perform tasks and work to achieve company goals and organizational objectives.

Job Duties/Responsibilities:
• Follow company policies and procedures.
• Set personal performance goals and provide input to departmental objectives.
• Establish work priorities to meet targets and timelines.
• Manage competing priorities and allocate, adjust, and optimize assigned department resources.
• Serve as the Quality representative on cross-functional and multi-site teams.
• Identify, design, and implement process and system improvements.
• Manage department and cross-functional initiatives.
• Apply advanced theory, technical principles, expert judgment, and cross-functional expertise to independently address a broad range of complex problems.
• Troubleshoot and direct the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.
• Serve as a technical subject matter expert (SME) in support of department functions.
• Develop and train personnel and internal customers on relevant business processes.
• Mentor junior personnel serving as a subject matter expert (SME) on Quality systems, processes and issues.
• Collaborate and author department policies and procedures.
• Make decisions that impact the goals and objectives of the department.
• Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance. 
• Sign documents for activities as authorized and described by Roche policies, procedures and job descriptions.
• Be accountable for behaviors as described in Roche Leadership Competencies.
• Perform any other tasks as requested by Management to support Quality oversight activities.

Technical Duties/Responsibilities:
• Manage the end to end change control process.
• Manage multi-site change control activities for the Biologic OU including but not limited to; Specifications, direct materials, validated systems, methods, qualified equipment, and controlled documents.
• Manage the Review and approve processes for changes. 
• Ensure system and process changes are reflected in appropriate procedures and controlled documents.
• Collaborate with internal departments and across sites to ensure understanding and execution of change control process and procedures.
• Facilitate and contribute to cross-site change management forums. 
• Develop and implement strategies for effectively managing multi-site changes 
• Lead change control process improvement activities
• Promote and provide guidance in Good Documentation Practices.
• Assist in developing training content and qualifications for change control processes and change management applications. 
• Serve as a resource for Change Control knowledge management across site Quality departments.  
• Collaborate with Quality departments in the administration, access, and communication of the Change Control system.
• Manage Record Management and Record Retention program activities and processes.
• Manage the centralized records repository.
• Collaborate with Operational and Quality departments to maintain GMP records.
• Provide metrics and reporting as needed.

This IT Manager is responsible for managing the Portfolio processes for Research and Development IT and for providing Project Management on a variety of projects that are used by Research and Early Development.  The position also oversees Portfolio/Project Management, Budgeting, Forecasting and related processes for Research and Development IT.  The position is part of the gRED IT organization.

Responsibilities: 

• Acts as Project Manager on projects, as assigned.
• Ensures that formal project management processes (PMM) are adhered to 
• for planning, chartering, and management of strategic initiatives and 
• projects. 
• Establishes and manages project teams and core teams to develop and 
• execute project plans. 
• Monitors projects and their progress towards goals, provides status, and 
• ensures issue resolution. Manages project budget and timeline to ensure 
• that they are efficiently delivered.
• Identify and implement process improvements in solution delivery and 
• support of new and existing solutions
• Collaborates with Pharma Informatics technology groups and business 
• functional groups, to ensure project delivery and on-going support of 
• applications.
• As the Portfolio Manager for gRED IT, partners and coordinates with Finance, gRED IT project managers and functional managers, other Portfolio Managers and the business to ensure appropriate project methodologies, governance and control processes are followed.  Also coordinates annual budgeting and monthly forecast/actuals processes and acts as the gRED IT representative on larger Pharma IT portfolio process improvement efforts.  Provides support and guidance to gRED IT project managers, as needed.
• Coordinates the yearly and project budget processes, including monthly forecasting, actuals analysis and resource management processes for your area of responsibility. 
• Provides support to the Director of gRED IT, as needed, related to creating general presentations, leading certain recurring meetings, etc.
• Participates in the Leadership Team of gRED IT organization

The AE&O Senior Project Manager scopes, plans and manages local, regional and global IT projects consisting of one or more delivery streams. He/she works with solution owners and project sponsors within AE&O (Architecture, Engineering & Operations) and SP&A (Shared Platforms & Applications).

As part of a team of project management professionals he/she reports to one of the Team Leads of Project Management within AE&O Project & Portfolio Management and is supported by portfolio analysts of the AE&O PMO and SP&A PMO (if applicable).

The Senior Project Manager is responsible for scoping, planning, managing and controlling global IT projects and reporting in a timely, accurate and transparent manner following standardized methods to allow accurate portfolio management and project execution control within AE&O and SP&A.

The senior project manager works closely with a responsible portfolio analyst from the PMO in AE&O (or SP&A) to ensure timely and accurate project reporting on project scope, schedule, cost and resources, as well as project risks, issues, action items, and dependencies.

In addition the senior project manager needs to collaborate closely with the Finance, Quality & Procurement departments as required. Also the involvement of other Pharma IT areas outside of AE&O and SP&A (as internal project workforce) might be required (e.g. Roche’s Shared Service Center in Warsaw).

Major Responsibilities include:

• Project Scope Management - Formulating and defining scope and objectives of the project in collaboration with the responsible Solution Owner and ensuring communication of project goals, schedule baselines, and business direction to all identified stakeholders
• Project Stakeholder / Communication Management - Identifying all relevant project stakeholders and establishing and implementing an appropriate communication plan to manage their requirements
• Project Delivery Primarily - Delivering the project on time, on approved (baseline) budget, within quality limits, and with the expected benefits, as defined at project entry and project baseline gates and through controlled and documented change management throughout project delivery, as needed
• Project Risk, Assumption, Issue and Dependency (RAID) Management - Actively managing risks, assumptions, issues and dependencies (RAID) by carefully assessing potential impacts in collaboration with the respective project teams and proposing appropriate mitigation actions. Is also responsible for identifying, actively managing and integrating with any dependent projects or activities.
• Project Planning, Tracking, Control & Reporting - Creating baseline project schedules and tracking the completion of project deliverables, tasks, activities and milestones. Providing accurate, timely and fit for purpose project status reports using established norms and reporting tools of the portfolio
• Team Building & Leadership - Organizing and supervising the appropriate involvement of project resources and actively managing and addressing the resolution of conflicts within the project team.
• Compliance – Directly accountable for ensuring compliance with project management, portfolio management and CSV policies, guidelines, process tools and reporting standards of the portfolio. These norms will include all system qualification/validation state documentation, project documentation and resource forecasting/tracking, financial forecasting/tracking and governance procedures of the portfolio for the specific projects assigned

The AE&O Senior Project Manager scopes, plans and manages local, regional and global IT projects consisting of one or more delivery streams. He/she works with solution owners and project sponsors within AE&O (Architecture, Engineering & Operations) and SP&A (Shared Platforms & Applications).

As part of a team of project management professionals he/she reports to one of the Team Leads of Project Management within AE&O Project & Portfolio Management and is supported by portfolio analysts of the AE&O PMO and SP&A PMO (if applicable).

The Senior Project Manager is responsible for scoping, planning, managing and controlling global IT projects and reporting in a timely, accurate and transparent manner following standardized methods to allow accurate portfolio management and project execution control within AE&O and SP&A.

The senior project manager works closely with a responsible portfolio analyst from the PMO in AE&O (or SP&A) to ensure timely and accurate project reporting on project scope, schedule, cost and resources, as well as project risks, issues, action items, and dependencies.

In addition the senior project manager needs to collaborate closely with the Finance, Quality & Procurement departments as required. Also the involvement of other Pharma IT areas outside of AE&O and SP&A (as internal project workforce) might be required (e.g. Roche’s Shared Service Center in Warsaw).

Major Responsibilities include:

• Project Scope Management - Formulating and defining scope and objectives of the project in collaboration with the responsible Solution Owner and ensuring communication of project goals, schedule baselines, and business direction to all identified stakeholders
• Project Stakeholder / Communication Management - Identifying all relevant project stakeholders and establishing and implementing an appropriate communication plan to manage their requirements
• Project Delivery Primarily - Delivering the project on time, on approved (baseline) budget, within quality limits, and with the expected benefits, as defined at project entry and project baseline gates and through controlled and documented change management throughout project delivery, as needed
• Project Risk, Assumption, Issue and Dependency (RAID) Management - Actively managing risks, assumptions, issues and dependencies (RAID) by carefully assessing potential impacts in collaboration with the respective project teams and proposing appropriate mitigation actions. Is also responsible for identifying, actively managing and integrating with any dependent projects or activities.
• Project Planning, Tracking, Control & Reporting - Creating baseline project schedules and tracking the completion of project deliverables, tasks, activities and milestones. Providing accurate, timely and fit for purpose project status reports using established norms and reporting tools of the portfolio
• Team Building & Leadership - Organizing and supervising the appropriate involvement of project resources and actively managing and addressing the resolution of conflicts within the project team.
• Compliance – Directly accountable for ensuring compliance with project management, portfolio management and CSV policies, guidelines, process tools and reporting standards of the portfolio. These norms will include all system qualification/validation state documentation, project documentation and resource forecasting/tracking, financial forecasting/tracking and governance procedures of the portfolio for the specific projects assigned

The primary mission of the Genentech Research & Early Development (gRED) organization is to discover and rigorously assess promising molecule candidates for viable therapeutic benefits. Within the Early Development segment, the Clinical Operations department is responsible for “first in human” Clinical Trials to assess the benefit and risks of a given therapeutic treatment and is embarking on a 3-year technology program to advance their organizational processes and capabilities.

As the gRED IT Tech Lead, your primary responsibilities are to provide modern technical solutions for the complex business needs in Clinical Operations, to contribute and coordinate IT project work and to support the operational technology landscape within the IT organization. You are a great team player, and self-driven individual who works well with other IT professionals towards the common vision of delivering information systems to enable the company to continue providing novel therapeutics for our patients.

Responsibilities:

• To design, develop, test and implement solutions based on customer requirements with an innovative approach.
• Able to work with customers to gather project requirements and can translate them into a functional solution.
• Provides architectural and engineering input in technical aspects of business planning such as program, project or roadmap planning. Collaborate with Global Architects as required.
• Provides deep technical expertise over a broad set of current technologies and mentoring of other team members in these areas. 
• Within project teams, collects and defines requirements, designs, develops, tests and documents final solutions according to Genentech's project management methodology
• Works with validation teams to ensure GxP validated solutions comply with FDA regulations throughout the solution lifecycle.
• In an operational setting, manages the deployment of software enhancements, troubleshoots production systems, contributes to root cause analyses and adheres to customer SLAs all while providing excellent customer service
• Works with a variety of in-house developed, commercial off-the-shelf (COTS) and SaaS software, across the globe, that provide organizational capabilities to manage Clinical Trials
• Experienced with web programming languages such as HTML, CSS, XML, PHP, Python, Perl and Java on Linux and Windows varieties.
• Experience with Business Intelligence and data warehousing solutions including Oracle databases, Informatica ETL, Business Objects and  Roambi mobile reports.
• Experience with Enterprise solutions including Google Apps, Livelink, Sharepoint, Jive SBS and iOS mobile applications.
• Collaborates with internal and external business partners and can lead contractors and vendors in design, development and testing activities.

Main Purpose of the Position

* Manage the lifecycle of contract manufacturing activities for commercial products at one or more bulk drug substance (DS) third-party contract manufacturing organizations (CMOs), including CMO selection, process technology transfer, routine cGMP manufacturing, and site decommissioning upon completion of the contract.  

* Establish and maintain alignment between CMO site business, operational and quality objectives and plans and Roche’s commercial and manufacturing strategies and plans.

* Establish and manage business, operations, and quality relationships and communications between Roche and the CMO as the Roche’s single point of contact for the contract manufacturing relationship at the Joint Management Committee and Joint Steering Committee levels.

* Build and lead cross-functional teams of technical, quality, regulatory, manufacturing, engineering, supply chain and other subject matter experts to achieve CMO site business, operational and quality objectives, plans, and performance goals.

* Provide the single point of accountability for identifying and managing timely resolution of business, operational, and quality issues through the established CMO site governance structure.

* Manage the performance and development of direct reports as required to achieve organizational and department goals and a productive work environment.

Job Duties/Responsibilities 

Contract Manufacturing Lifecycle Management

1.   Selection.   Build and lead the Roche cross-functional team charged with for identifying, evaluating, and selecting and negotiating a contract with a CMO for bulk contract manufacturing, specifically:

* Develop CMO selection plan, define contracting manufacturing requirements and evaluation criteria, and identify and screen CMO candidates.

* Develop Request for Proposals (RFPs), and solicit and evaluate contract manufacturing proposals.

* Lead due diligence visits, analyze and evaluate CMO proposals, and develop recommendation(s) for CMO selection.  Drive decision-making for CMO recommendation through appropriate governance committees.

* Lead contract negotiations for technology transfer and manufacturing and supply agreements.

2. Implementation.  Build and lead the cross-functional team charged with transferring, qualifying, and achieving regulatory licensure the process and analytical technologies (“technology transfers” for manufacturing Roche’s DS products at a CMO’s manufacturing facility, specifically:

* Lead the Technology Transfer project for Roche through regulatory licensure of the CMO’s facility for routine cGMP manufacturing, including serving as the Leader of the Joint Management Team.

* Plan and manage the transfer of Roche’s DS manufacturing process(es), analytical testing technologies, and supply chain processes to achieve product and process comparability between the donor and receiving sites.

* Manage the project governance structure, including identifying and managing issue resolution and milestone stage gate reviews.   

* Oversee and manage contractual commitments, obligations, and processes, including milestone dates, financial terms, dispute resolution, and materials and equipment.

3.   Site Management.  Build and lead the cross-functional team charged with managing contract manufacturing at CMO following regulatory licensure, specifically:

1.1. Business

* Serve as Roche’s Site Manager, actively managing the on-going relationship with CMO to ensure Roche’s expectations for product quality, cGMP compliance, costs, and production targets are clearly understood, well-documented and consistently met.

* Lead project team meetings and technical operations meetings.

* Coordinate and manage visits and contact between Roche personnel and the CMO.

* Establish and maintain a Joint Service Agreement with the CMO that defines roles and responsibilities, business processes, systems and tools, supply chain assumptions and standards, and performance metrics to foster an effective and efficient business relationship. 

* Manage and monitor contractual commitments, obligations, and processes, including milestone dates, financial terms, schedules, materials, and equipment.

1.2. Operations

* Serve as site Technical Lead, coordinating technical review of process data and proposed facility, equipment, system, or process changes with Roche Subject Matter Experts (SME's).

* Facilitate issue resolution and problem solving within CMO site, with Roche functional departments supporting Contract Manufacturing, and through the agreed project governance structure as appropriate.

* Coordinate cross-enterprise forecasting, capacity planning, scheduling, and inventory management processes for critical raw materials and DS.  

o...

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.

Job Duties/Responsibilities

• Leads the development, planning, directing and tracking of the validation of GxP computer systems operated by North American ERP team (i.e. SAP ERP, BW, APO, XI, Solution Manager, GRC, Portal and Business Objects).
• Responsible for the quality systems and processes that ensure computer systems are operated and maintained a validated state. This includes all modifications and / or changes to systems or processes, change control, periodic revalidation activities and ensures a continual state of inspection readiness with regard to cGxP’s.
• Leads the Information Technology and Quality team members to develop and implement validation strategies in accordance with company policies, directives and government regulations.
• Develops and writes validation project plans, master validation protocols, acceptance criteria traceability matrices and summary reports by providing instructions and scientific rationale for the performance of validation studies.
• Leads fellow technical and analysis team members in ensuring quality systems and processed are in compliance with corporate quality directives, policies, standards and procedures.
• Responsible for the maintenance of departmental quality systems and procedures to assure compliance with new and revised corporate standards and policies.
• Coordinates the testing efforts of the IT and business teams with regards to requirements, resource planning, test coverage, test strategies for the orth American SAP systems.
• Coordinates and interacts with all affected personnel in the execution of test scripts and validation protocols and gathering of test data. Ensure all protocol executions are documented and recorded in accordance with company quality policies, quality standards and SOPs.
• Reviews and approves validation data to assure protocol acceptance criteria is achieved and all deviations are completed and recorded according to procedures.
• Ensure all final reports are completed according to procedure.
• Coordinate and manage the application release cycle processes.
• Manage the life cycle documentation.
• Recommends methods for process improvement, detailing process strengths and weakness of existing and proposed procedures and controls
• Participate in internal and external vendor audits and regulatory audit teams.
• Define and maintain GxP training program to support compliance requirements for IT staff.