Job Purpose:

The PDQA GCP TA Strategy Lead is responsible for the development and implementation of a GCP risk based strategy to deliver an audit program and quality oversight model for studies/products within a therapeutic area.  This role provides oversight to the PDQA program contacts to ensure consistent application of risk based strategy for each program within a TA, and provide actionable data to Therapeutic Area Senior PD management based on analysis of data (audit/inspection/risk) and identification of trends.  This role is to influence TAs in the area of risk and quality management so they can proactively identify and address issues.

Primary Responsibilities and Accountabilities:

• Design and implement a global GCP risk-based Strategy for audit and risk assessment activities for each program in a TA
• Develops and performs risk assessment strategy on each program in TA 
• Supports Program Contacts in risk assessment for each study in program and helps define PDQA priority studies list 
• Develop and maintain risk assessment tools
• Monitors risk data and recommends risk mitigation strategies to TA
• Oversee completion of TA and protocol specific Quality plans
• Input program specific information into risk assessments of internal processes and service providers
• Provide back-up support to all Program Contacts for a specific TA
• Assess and adjust the audit strategy for CTC audits (internal and compliance audits)
• Functions as an audit report reviewer for outsourced CTC Compliance audits
• Analyze data/metrics from audits, inspections and risk management activities for compliance trends and risks for all programs within a specific TA 
• Develop and deliver summary reports (audit/inspection/risk metrics and trends) to TA Leadership
• Provide compliance advice to the TA/product teams and PDQA staff
• May lead or participate in GCP audits for TA 
• Support inspection readiness and inspection management activities for products within a TA
• Support regulatory authority GCP inspections for products in Therapeutic Area

• Provides leadership and direction to PDQ/PDQA and our customers/stakeholders on GCP related activities/issues 
• Establish strong partnership/relationship with TA Senior PD Management
• Review and provide feedback on study risk mitigation plans/CAPAs 
• Escalate significant compliance issues to PDQA Management
• Support PDQ Partner Services in the implementation and oversight of QMS for PDG 
• Provide responses to GCP questions received from Compliance Help Desk for TA

• Contribute to the development and execution of PDQA goals and initiatives
• Participate in or lead departmental or cross-functional compliance projects and initiatives as assigned
• Assists and/or contributes to the development and/or revision of PDQA SOPs, guidelines and tools

• Maintains highest level of awareness, expertise in international GCP regulations and internal policies and SOPs

The QA Product Technical Manager is the key point of contact for all issues affecting the disposition of their assigned product(s). This individual will be responsible for interacting with multiple departments within Roche to assure that all lot disposition issues are identified and resolved within standard lead times.
• Perform assigned tasks and work to achieve company goals and department objectives.
Job Duties/Responsibilities:
• Follow company policies and procedures.
• Maintain a state of inspection readiness.
• Provide input to the development of personal performance goals and departmental objectives.
• Collaborate with Management to establish and meet targets and timelines.
• Support routine operations and allocate assigned resources.
• Manage competing priorities.
• Serve as the Quality representative on cross-functional and multi-site teams.
• Identify, design, and implement process and system improvements.
• Lead and participate in the design and implementation of department and cross-functional initiatives.
• Apply advanced theory, technical principles, and expert judgment to address a broad range of difficult 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.
• Train personnel and internal customers on relevant business processes.
• Sign documents for activities as authorized and described by Genentech policies, procedures and job descriptions.
• 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.

Technical Duties/Responsibilities:
• Oversight of the activities associated with dispositioning of assigned production lots within established standard lead times.
• Management of lot disposition activities to ensure that products are dispositioned in accordance with regulatory requirements, cGMPs and Genentech policies and procedures, within established standard lead time.
• Interfacing with appropriate departments or manufacturing plants to ensure that lot disposition items are completed.
• Notification to Senior Management for all known delays in meeting established standard lead times or any potential significant quality issues.
• Interfacing with QA Lot Disposition Supervisors and Final Reviewers to ensure that final review activities are completed. Lead and provide guidance to Final Reviewers as required.
• Perform a review of investigations for potential cumulative effect to a batch history record.
• Perform a review of QC out of trend results for cumulative effect.
• Provide assistance to CMC teams by addressing lot disposition issues as they arise.
• Support regulatory inspections as needed.
• Assess batch history records as part of investigations into product complaints.
• Revise and approve applicable lot disposition documents as needed.

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.

Oral Octreotide Brand Trainer
*Position is based in SSF headquarters

The Brand Trainer supports specific brands in which the responsibilities are a combination of Clinical Trainer and Sales Trainer. Therefore, the Brand Trainer must possess a thorough understanding of the assigned brands product(s) in addition to be able to create training programs for both new hires and advanced sales representatives.

Major Responsibilities:

• Determines the most effective approach to meet product-learning needs of the specific brand business. Applies instructional design principles and adult learning principles to enhance content delivery.
• Establishes goals and learning objectives to design appropriate and effective curriculum by leveraging adult learning principles.
• Researches the clinical issues and leverages resources (internal and external) to support the learning objectives in designing and creating training programs and products.
• Prepares and/or oversees the preparation of clinical training products and programs such as classes, workshops, learning modules, poster books, and other job aids and materials for distribution to CT&D customers and program participants.
• Develops Brand training programs as identified from Sales and Marketing teams focusing on Brand strategies and tactics that will ensure significant impact on increasing business.
• Facilitates Foundation (Phase I), Core (Phase II), and Advanced (Phase III) Training Classes – skilled at group facilitation and group learning exercises.
• Designs and implements metrics to measure clinical training programs and products impact, effectiveness, appropriateness, and utility.
• Filters and distributes educational resources (i.e. clinical papers) to the CT&D customers and other appropriate audiences while remaining contentious of legal and regulatory parameters.
• Collaborates with all CT&D customers and resources: Sales, Marketing, Development, Medical Communications, Clinical, Legal, Regulatory, Library Services, etc. to ensure consistency, avoid redundancy, and that needs are met and leverage internal resources thereby ultimately, enhance training programs.
• Communicates appropriate Commercial Training and Development (CT&D) programs and resources to all customer segments to help support the Commercial Organizations strategic goals.
• Participates as an active member on Commercial and Brand product teams
• Facilitates “Selling Excellence” training programs that will enhance the effectiveness of the field sales organization
• Participates on CT&D internal training initiatives

This position may be filled at an Associate Services Manager or Contract  Manager level.
 
Contract Services Managers are responsible for contract services (including contract set-up, membership and affiliation assignment and maintenance) and/or customer payments in accordance with accuracy and compliance requirements. Customer payments may include responsibilities, as assigned, for processing fees, rebates, discounts and chargebacks, as per the terms of each contract. Additionally, Contract Services Managers act as subject matter experts (SMEs) on SPCM Contract Operations processes, collaborating with Contract Operations partners and stakeholders in various meetings, initiatives and projects. Expertise in the processes, calculations, systems and Standard Operating Procedures (SOPs) that support contract services and customer payments is critical to success in this position. Contract Services Managers, by comparison to Associate Contract Services Managers, also have responsibilities for developing complex analyses and reports, reviewing from the work of less experienced team members, performing contract set-up and structure for other team members, managing Internal Control Over Financial Reporting (ICFR) tracking and monitoring activities, and leading projects to improve processes and procedures.

• Acts as a lead SME for assigned contracts, other activities, SPCM Contract Operations systems, processes and SOPs
• Plays a lead role in cross-functional initiatives involving new/updated pricing and contracting strategies, terms, conditions, language and the like 
• Proactively seeks out complex information on changes in laws, regulations and other external factors and dynamics. Works with manager and other internal partners/stakeholders to interpret the information and assess its effect on current contracting models, pricing, discounts, rebates, chargebacks, compliance and the like. Develops appropriate responses, including recommending changes in complex pricing and contracting strategies, programs and contract administration
• Plays a lead role in development, education, communication, implementation and ongoing maintenance of Contract Operations SOPs, systems, processes, data, reporting templates and the like. Includes serving as a liaison for technology-related projects to ensure systems or enhancements are designed to meet the operational needs of Contract Operations and supporting testing for new or updated systems 
• Works with manager and others to establish appropriate performance metrics for monitoring, evaluating and reporting on contracts, contract performance and other business, legal and regulatory requirements
• Plays a lead role in development and delivery of Contract Operations training; including conducting training for other staff members and, as appropriate, others outside of the department
• As assigned, leads or otherwise participates in and supports other special projects
• As assigned, my perform some or all of the following: perform some or all of the following:
• Enters contract information into departmental systems and databases Performs contract set-up and maintenance. Includes 340B Program Integrity support and assigning customers to appropriate contract groupings and class of trade (membership and affiliations), coordinating and managing contract term reviews
• Collaborates with other departments to determine appropriate pricing eligibility for new managed care customers; identifying customer entities, class of trade and appropriate contract pricing
• Implements departmental changes arising from such things as complex pricing strategies, updates to operating procedures, or internal policies affecting Contract Operations
• Uses relevant contract terms, conditions and other regulations, policies, etc. as well as appropriate systems and tools to evaluate, calculate, validate and process customer payments 
• Prepares payment packets as per the terms of each assigned contract. Ensures packets are routed through to all appropriate partners/stakeholders for review and approval
• Works with Customer Finance and other partners/stakeholders to track customer payments and ensure accurate and timely payments are made to customer accounts. Helping ensure penalties are avoided 
• Develops and evaluates contract performance using approved financial modeling templates
• Completes ICFR tracking and reporting, as per business and legal requirements and departmental policies & procedures
• Prepares, obtains approval for and ultimately publishes departmental scorecard reports, customer business review reports, various compliance and other ad hoc reports
• Performs ongoing membership and affiliate maintenance. May include updating membership/affiliation on an exception basis in accordance with business rules
• Responds to...

Lead process improvement projects at supplier sites as part of Supplier Management process, CMO light

Working with Genentech technology transfer teams lead:

•      Raw material transfers to CMOs

•      Raw material transfer from customers (insourcing projects)

Responsible for SAP management as an SME; provide updates and training of the group in the areas of Supplier and management of raw materials

Responsible for managing, negotiating and completing Quality agreements with suppliers

 Duties/Responsibilities:

·         Troubleshoot and direct the resolution of raw material Quality issues by fostering effective interdepartmental and cross-functional partnerships. Provide solutions to complex manufacturing, quality and negotiation problems.

·         Develop project plans and establish work priorities to meet targets and timelines.

·         Identify, design, and implement process and system improvements.

·         Manage department and cross-functional initiatives and activities.

·         Apply, technical principles, expert judgment, and cross-functional expertise to independently address a broad range of complex problems related to chemical and component materials.

·         Serve as a technical subject matter expert (SME) in raw material and component requirements/specifications review and approval.

·         Serve as a trainer and train internal personnel (as needed) on SAP processes related to raw material management.

·         Collaborate and author department policies and procedures.

·         Be able to make decisions using a collaborative and cross functional process

·         Be able to apply good judgment and notify and escalate to Management potential quality or regulatory issues that may affect product quality or regulatory compliance. 

·         Author, review and approve technical  reports as a result of projects

·         Be accountable for behaviors as described in Genentech’s Core, Common, and Critical Competencies.

·         Set personal performance goals and provide input to departmental objectives.

·         Manage competing priorities and allocate, adjust, and optimize assigned department resources.

·         Perform any other tasks as requested by Management to support Supplier Quality oversight activities of chemical and component suppliers.

Technical Duties/Responsibilities:

Work with internal, CMO and customer groups and lead the tech transfer of raw materials. 

In partnership with GNE’s critical and standard suppliers ensure uninterrupted supply and internal raw material management groups perform the following technical duties.  .

•      Review Supply agreements and implement Quality Agreements with suppliers (as applicable)

•      Lead and or participate in Business and performance review meetings as applicable

•      Participate in supplier Risk Assessments, and  Supplier Analysis with Procurement (as applicable)

•      Lead  supplier site technical visits to review entire manufacturing processes related to manufacturing of chemicals, components and diluent materials

•      Partner with supplier on internal audits (when possible)

•      Perform supplier audits as needed

•      Write and review technical reports

•      Represent GNE  in customer advisory boards

•      Design and issue supplier business and Quality reports annually

•      SME representative in the SAP team

The IT Business Systems Analyst position will be responsible for working closely with partners across lines of business and the IT group in order to understand strategic drivers and tactical needs to ensure that implementation teams can provide solutions that meet the business need with the necessary stability, usability, and scalability. The IT Business Systems Analyst will be supporting projects in the global Laboratory Information Management Solutions portfolio for manufacturing and clinical Quality Control laboratories.

Duties:

• Analyzes business scenarios and identifies opportunities for improvement through automation and/or business process change
• Provides analytical expertise in identifying, evaluating, designing and developing systems and procedures that are cost effective and meet user requirements.
• Develops user requirements, functional requirements and/or technical specifications, process flow diagrams; may configure some system settings and/or options.
• Provides consultation to users in the area of business systems and processes.
• Leads cross-functional analytical teams in the resolution of business or systems issues.
• Leads successful completion of major projects/programs across portfolios. 
• Champions accountability by example.
• Applies advanced technical principles, theories, and concepts related to requirements, data, usability and process analysis.

• Other duties as assigned:
• Conducting 1:1 or group interviews, facilitating workshops
• Facilitating and supporting GMP validation, system and user acceptance testing
• Participating in roadmap discussions and vendor assessments
• Overseeing and mentoring less senior resources on solution or project teams
• Overseeing consultant resources as applicable

The Manufacturing Site IT Lead is the primary IT point of contact for the Vacaville Biotech Manufacturing facility leadership team: an escalation point for issues, business partner on opportunities, communications channel between the site and Pharma Informatics and an active participant in the Global / Regional IT management of change process.

This position also has leadership and management accountability for two virtual teams: An Application Support team that focuses on the support of Local and Regional Manufacturing and Engineering solutions, and a Tools Team that develops and maintains small custom applications for Manufacturing Sites.

Primary Accountabilities

Engagement:

• Matrixed to a member of the Plant Manager’s leadership team, and expected to contribute cross functional leadership and expertise to the success of the site
• Expected to build and maintain close business relationships with site leaders and stakeholders
• Expected to understand the local Biologics manufacturing site business strategy, objectives and priorities, and communicate appropriately within Informatics
• Advise Site Leadership on Pharma Informatics policies and opportunities
• Represents the customer’s view in the overall Pharma Informatics portfolio discussions and informs them about portfolio decisions
• Represents Site in Manufacturing Site IT Lead forum, contributing to cross site initiatives as assigned

Service and Project Delivery:

• Collaborates closely with the global delivery solution centers
• Develops and manages the Biologics manufacturing site Informatics portfolio in alignment with the global business objectives and governance processes
• Drives efficiency by utilizing globally defined best practice processes for Informatics operations
• Follows defined working processes and standards (Corporate, Biologics and Informatics) in the execution of daily duties and job function
• Aligns local activities and solutions with global ones and vice versa
• Works with Global IMs and Solution Center Managers to create solutions and initiate projects
• Ensures true end-to-end services
• Manages local vendor relationships, service levels and contracts where applicable
• Monitors services and provides regular service reports to the Global Information Managers, delivery and business clients

Alignment:

• Ensures standardization of applications by promoting shared processes, data harmonization and architectural compliance where possible
• Ensures that the shop floor and lab systems are optimally operated at the site
• Ensures the applications fit the needs and capabilities of the customer’s organization and SLAs are defined and supported as well as systems remain validated and documentation is maintained
• Ensures standardization of applications and promotes shared processes, data harmonization and architectural compliance where possible

Management:

• Coordinates the analysis, design and development of Tools projects, upgrades, and the deployment of new services or products
• Manage support of ~40 local, regional and global applications 
• Manage production and internal escalations
• Manage M&E (Maintenance & Enhancement) process for Local / Regional Manufacturing and Engineering systems 
• Manage external consultants and near-shore (e.g. ADMD) resources to supplement team
• Manage, coach and support development of individual team members’ careers
• Appraise team and individual performances
• Manage operational and project budgets of the team
• Participate in the Leadership Team for the PT Biologics IT organization

 Purpose: 

The Genentech Research and Early Development (gRED) Clinical Program Leader (CPL) position is accountable for operational strategy for assigned early development programs. The CPL is accountable for functional management including recruiting, building and maintaining a high quality gRED Clinical Operations organization. 

Primary Accountabilities and Responsibilities: 

Program Management Responsibilities: 

Through appropriate leadership, direction and operational expertise, lead the development and execution of operational strategies for multiple molecules/programs in Genentech’s early development portfolio: 

• Represent Clinical Operations on the Early Development Teams (i.e. Core, Development or Clinical Sub-Teams) 

• Develop program timelines and budgets and manage variance 

• Provide strategic, operational input to clinical development plan (CDP), target product profiles (TPP) and project plans 

• Lead the Clinical Operations team to ensure effective development, implementation and execution of all clinical trials within agreed timelines, resources and budget 

• Develop and present operational plan to management review bodies 

• Identify program risks and develop and implement mitigation strategies for assigned programs 

• Define the resourcing and outsourcing strategy for early development programs 

• May participate in Business Development assessments 

• Work collaboratively, effectively, and efficiently with all internal and external partners and stakeholders 

• Partner with Business Management to identify strategic business needs to support the clinical programs 

• Partner with late-stage development leaders to ensure strategic alignment on the CDP 

Functional Management Responsibilities: 

Identify, recruit, hire, and develop Clinical Operations staff, as well as oversee their work to ensure all department goals, deliverables, and objectives are met. Additionally, contribute to the Clinical Operations organization. These responsibilities include: 

• Manage Clinical Operations staff including development, coaching, mentoring, performance management, and succession planning 

• Ensure that employees are appropriately trained and comply with company and regulatory standards 

• Create a positive work environment by encouraging mutual respect, innovation and accountability 

• Resource projects to enable teams to meet deliverables 

• Create and maintain Clinical Operations as a ‘great place to work’ 

• Participate in and/or lead working groups and/or initiatives within the gRED organization or cross functionally as required 

• Partner with Process and Training Management (PTM) to optimize and continually improve processes; to create and maintain role definitions and standards; and to develop role-based competency and training programs 

• Create an environment supporting innovation and smart risk to help the department continuously evolve, improve and excel *LI-EK1

Crystallography Post Doctoral Fellow - Hymowitz Lab

Responsibilities:

A position is available for a postdoctoral fellow with expertise in crystallography to join the Department of Structural Biology at Genentech, Inc.  Active areas of research include the structure and function of intracellular signaling cascades involving ubiquitin as well as the structure and function of protein complexes relevant to human disease. The successful candidate will be involved in all aspects of crystallography, including expression and purification of proteins, crystallization, data collection, structure determination and analysis of protein structures.

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.

Statistical Programmer (SPA-2) 

Position Purpose:

The Statistical Programmer has responsibility for statistical programming support for the Pharma Development, gRED, pRED, and/or EpiPRO organizations.  He/she supports statistical programming teams on assigned study level activities in planning, designing, and implementing statistical software solutions for the reporting and analysis of clinical trials in accordance with applicable processes.     

Major Responsibilities and Accountabilities:

 Contributes to SPA team in preparing summarized information to clinical study team members

 Assist statistical programming activities at study level or components of a clinical project as applicable

 Able to access and clarify requirements, provide statistical programming solutions and ensure their efficient implementations under supervision

 Under guidance of a senior SPA, develops approaches to meet the study and project requirements

 Assist in determining and developing approach to technical solutions

 Responsible for accuracy and reliability of results.  Builds and monitors quality in every aspect of job activities. 

 Has an awareness and familiarity with the types of risks associated with a study and the impact on the quality of deliverables

 Is aware of timelines and scope based on resourcing / priority constraints within the SPA team and understand their implications on individual work assignments 

 Builds and maintains effective working relationships with SPA team members.

 Adapts to changing circumstances, policies, work assignments, and/or team members.  Able to multi-task and prioritize between tasks

IT Quality is a trusted partner for customers to ensure and improve the overall quality of IT systems throughout their lifecycle with a focus on compliance with regulatory, legal and finance requirements.  We are looking for a customer-focused, highly collaborative individual responsible hosting and supporting audits and inspections and ensuring audit corrective actions are tracked and closed in a timely manner.   The position is responsible for effective planning and management of audits and inspections with business quality and audit groups.  Further responsibilities include:

• Leads, hosts,  and supports audit management for IT for various sites for internal and external audits and inspections and provides regular updates to stakeholders and informs management of potential issues
• Prepares IT teams for audits and inspections using his/her knowledge of IT controls and auditing practices and provides training to IT staff in support of key IT controls and audit readiness procedures
• Manages the audit program in compliance with quality requirements for ICFR, FDA regulations, legal and security policies, IT controls.
• Facilitates execution of corrective actions ensuring that weaknesses identified in the IT management system are identified, recorded, prioritized and addressed appropriately.  
•   Conducts vendoraudits and internal system assessments for Informatics
• Serves as custodian for legacy IT controls, IT Narratives, Master Audit Schedule to support audit and compliance processes.
• Develops, monitors and improves processes and tools to improve the compliance of  IT systems and to facilitate joint business decision making from a cross-functional and global perspective
• Develops strong working relationships with and partners effectively with IT delivery teams and with global Business Quality, Corporate Audit, Finance and security organizations
• Maintains industry knowledge and skills in the compliance, audit, and risk management and  applies them to improve internal processes and practices

TheImmunology, Tissue Growth and Repair Diagnostic Discovery Department is seekinga motivated, interactive and flexible Senior Research Associate to perform researchrelated to biomarker discovery and analysis in infectious diseases. 

Theposition will report to a Scientist lead for the Department's new program inInfectious Disease and Host-Pathogen responses. The successful candidate willimplement a variety of in vitro and in vivo molecular, proteomic and cellulartechniques to elucidate disease pathways and identify relevant biomarkers, andwill be expected to make intellectual as well as technical contributions to theteam. Responsibilities: Perform wet lab experiments, generate and analyze dataand communicate findings and interpretations relevant to the Department'smission to identify predictive and prognostic biomarkers for therapeuticResearch and Development programs. Specific responsibilities will include:performing exploratory disease-oriented research utilizing samples & datafrom human infectious disease cohorts, processing and analyzing clinical trialsamples, data analysis and presentation, and contributing to experimentaldesign/planning.

CDM Process Analyst

Performs tasks described in previous job level and additional tasks as specified below:

1. Represents CDM PTM within the Biometrics community

2. Provides guidance on CDM best practices and compliance based upon existing controlled documentation

3. Facilitates the development and refinement of CDM processes

4. Adjudicates comments to ensure the process reflects current business practices

5. In collaboration with subfunctional managers, develops, reviews and updates job role training qualifications

6. Liaises with PDQP regarding the creation and ongoing maintenance and training of processes

7. Serves as the single point of contact at the respective sites to the Inspection Readiness Coordinator

8. Recommends process improvements based on other companies and industries through literature review, attending professional conferences and direct sharing of information

9. Ensures document consistency

10. Acts as change and transition agent during new process implementation

11. Develops and maintains standard tools and templates to support Clinical Data Management processes

12. Ensures job role training qualifications are in alignment with industry

13. Challenges and supports Clinical Data Management staff to critically review

current processes for effectiveness, quality and simplification

14. Provides mentorship to less experienced Process Analysts

15. Provides guidance and oversight to PTM contractors

16. Contributes or leads local and subfunctional working groups and initiatives

17. Leads or participates in the local functional/crossfunctional implementation of best practices and process improvement initiatives

18. Is responsible for complex deliverables for the subfunction for one or more projects

19. Effectively communicates ideas, project goals and

status of work and independently presents at department meetings

20. Identifies and develops solutions to complex problems

21. Sets targeted timeframes for deliverables and anticipates potential scenarios that may create timeline delays

22. Is able to influence and negotiate a positive outcome

23. Evaluates probability, impact and priorities of risks and develops and implements mitigation plan

24. Articulates functional knowledge in the development of subfunctional processes, training and related documents

25. Partners with PTM Training community to ensure best training practices are being leveraged in process training

Responsibilities: This position is for a Validation Engineer I/Manufacturing Technical Specialist I - Validation reporting to a Manager of Technology Validation in the South San Francisco Production Technology Department.  The candidate will be responsible for Validation scope supporting the South San Francisco manufacturing plants.  This includes drafting and execution of validation protocols, authoring validation and technical reports and development of project plans.  In addition, the candidate will support technical assessments for quality impact and participate on quality investigation teams.  The candidate will also monitor maintenance of the validated state of basic and some complex equipment and processes.  This includes monitoring operations and resolving moderate validation issues.  The candidate will support introduction of clinical products into manufacturing by participating on campaign/product planning teams and delivering the appropriate validation activities consistent with project timelines.  The candidate may lead cross functional teams or projects.  The candidate will be expected to work effectively in teams, to influence others to generate support for assigned activities or projects and to justify goals to department colleagues.  They will also act as a mentor for those with similar or less validation expertise.

System Specialist, gRED Desk-side Support

• The gRED Desk-Side Support Specialist supports multiple computing platforms such as Mac, Windows, Linux, and iOS in laboratory and desktop computing environments. 

• The successful candidate will also apply networking concepts, printer troubleshooting, hardware and software troubleshooting knowledge and data backup technology in day-to-day operations. 

• While working in a highly team-oriented environment, the gRED DSS Specialist will work to achieve defined metrics within the incident management and request fulfillment processes and also be a technical resource to junior team members. 

• The successful candidate would also have the potential to lead team efforts. 

• Serve as a technical lead for one or more fill-finish process transfers to contract/partner manufacturing sites, as well as between Genentech/Roche manufacturing sites.
• Provide on-going fill-finish manufacturing support to the CMO or internal manufacturing sites by performing trouble shooting, product impact assessments during deviations and investigations and process improvements. 
• Work collaboratively with the site MSAT groups, Late Stage Pharmaceutical Development groups, Manufacturing Operations, and Engineering to develop in-depth knowledge of the fill-finish processes and to facilitate technology transfers.
• Author and review technical reports, process validation documents, and portions of regulatory submissions to support licensure.
• Identify and communicate manufacturing best practices, and work to ensure manufacturing process consistency across the different fill-finish facilities.
• Lead and participate in cross-site and cross-functional teams responsible for technical oversight of drug product manufacture and process improvements, developing global standards, troubleshooting issues, analysis of cross-site process performance data and implementation of quality standards.
• Lead and/or guide the product technical teams (PTTs), serve as a member of the PTT, collaborate closely with the product supply chain, quality and regulatory lead.  Participate in Joint Management Teams (JMT) for CMO transfers for functional representation and/or team updates.

·         Follow company policies and procedures and be accountable for behaviors as described in Genentech’s Core, Common, and Critical Competencies

·         Lead product complaint investigations with minimal guidance and ensure investigation action plans and final investigation summaries are accurate, include appropriate corrective actions, and follow company standards.

·         Apply advanced theory, technical principles, expert judgment, and cross-functional expertise to independently address a broad range of complex problems.

·         Develop solutions to complex product complaint issues and Quality initiatives with inter-organizational impact following cGMP regulations and Genentech standards. 

·         Ensure appropriate application & integration of cGMPs in the product complaints management system.

·         Set personal performance goals and provide input to departmental objectives.

·         Establish work priorities to meet targets and timelines and manage competing priorities/

·         Serve as the Quality representative on cross-functional and multi-site teams.

·         Identify, design, and implement process and system improvements.

·         Troubleshoot and direct the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.

·         Develop, train, and mentor personnel and internal customers on relevant business processes.

·         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. 

·         Inform management of critical product complaints and provide timely impact assessments of potentially affected products, materials or processes.

·         Review and approve product complaint investigation reports and supporting documentation. 

·         Lead collaboration with departments to establish appropriate, efficient, and timely investigation strategies.

·         Educate departments on the best practices for conducting investigations and root cause analysis.

·         Lead project teams to resolve deficiencies identified through the root cause analysis process.

·         Assess the accuracy of root cause determinations based on a thorough evaluation of possible failure modes.

·         Present product complaint records and/or reports during periodic audits and regulatory inspections.

·         Perform any other tasks as requested by Management to support Quality oversight activities