We are seeking a highly motivated individuals to join the Oncology Biomarker Development Dept. to lead companion diagnostic (CDx) development programs in support of the Roche / Genentech early and late stage Oncology clinical development pipeline. The incumbent will provide leadership for a portfolio of molecules within a Franchise and represent these programs to senior management and decision-making bodies internally.

The CDx development strategies will be closely aligned with clinical development program timeline and strategy to enable robust clinical validation of the CDx, including establishment of thresholds and statistical analysis of the relationship with efficacy or safety using robust assays developed with diagnostic partners. The incumbent will also develop cross- functional relationships with internal scientific, operational and regulatory groups and diagnostic partners, and represent GNE / Roche CDx efforts to external professional organizations and regulatory bodies. The successful candidate will also be expected to contribute to Medical Affairs strategies to enable biomarker hypothesis testing.

Responsibilities

• Work closely with the biomarker, regulatory, statistics and clinical leadership to ensure development and effective operational execution of the CDx portfolio of multiple investigational agents in Franchises or Disease Area
• Management of direct and matrixed reports whose responsibilities will include programs in both early and late stage clinical development. A substantial focus will be in early development where design of CDx strategies that enable device development in preparation for hypothesis testing will be important. Therefore requires strong understanding and experience with development of diagnostic devices in order to develop fit for purpose CDx strategies.
• Develop and lead strategic initiatives to identify novel CDx technologies and develop relationships to enable effective evaluation of technologies as CDx assays.
• Develop and lead IVD strategies that are aligned with disease areas including development of multiplex platforms to support investigational and approved products in collaboration with diagnostic partners.
• Enable the coordination and execution of exploratory biomarker hypothesis testing in the clinic.
• Develop relationships with external key investigators, scientists and professional organisations in the diagnostic technology field to inform internal CDx strategies including next generation technology implementation and validation.
• Represent CDx strategy to health agencies as part of the regulatory strategies for the agents within the entire portfolio.

3 positions available for locations in SSF. Washington DC or Basel

Main Purpose of the Position:

·        Provides objective and uniform assessments of quality and compliance risks across global network, including independent expert review of (1) the internal GMP auditing program and (2) correspondence to global health authorities regarding GMP issues.

·        Supports support liaisons and interactions with external bodies and committees to influence on technical quality issues through articles, speeches and participation on committees

Job Duties/Responsibilities:

·        Performs independent expert assessment to determine global uniformity and conformance to appropriate regulatory standards for (1) internal GMP audits and (2) correspondence to global health authorities regarding GMP issues, including written responses to inspectional observations.

·        Advise senior management across PT Global network on best practices, regulatory intelligence, key opportunities, and possible threats in the areas of quality and compliance. 

·        Provides up to date regulatory and compliance information and trends, specializing in specific regulatory authorities and regions, providing timely information to the PTQ organization.

·        Contributes to expert GMP compliance opinions for PT Global network, including Manufacturing, Quality, and Regulatory Affairs.

·        Participates as a key member of teams throughout the global Technical Operations Quality organization for strategy and policy, external interactions and influencing activities as they relate to Quality and GMP/GDP Compliance

·        Supports the overall efforts for strong health authority relationships in the areas of Quality and Compliance through effective communications, interactions and participation in meetings, conferences and committees with focus on respective region or area of expertise.

Provides clinical oversight for a variety of projects, in consultation with his/her Medical Director or Senior Medical Director :

·         Works with a host of internal and external partners and stakeholders in the implementation of clinical trials for assigned drugs/indication

·         Provides scientific input into and/or coordinates the development of specific clinical trial documents for review and discussion with Medical Directors* (e.g., protocols, charters, safety monitoring plans, process documents, etc.) including disease and/or treatment registries

·         Participates in the identification of appropriate external investigators

·         Oversees the clinical trial implementation, ongoing monitoring and evaluation, working closely and regularly with external investigators and Clinical Operations. Active Member in Study Management Team for assigned drugs/indications

·         Develops and cultivates relationships with external partners such as clinical investigators, clinicians, scientists and KOLs, as well as cross-functional partners in Clinical Development, Commercial, Legal and Regulatory.

·         Supports his/her manager in developing clinical components of presentations* for clinical trial investigator meetings

·         In collaboration with his/her manager, coordinates the preparation and reviews data outputs for reporting documents* where appropriate (e.g. clinical study reports, analysis plans, etc.) with the CRO, the Medical Affairs Biostatisticians and his/her Medical Directors

·         Monitors project progress and is expected to proactively identify any issues or challenges and recommend and implement strategies to effectively resolve such once approved with his/her manager

·         Works closely with his/her manager, the publication team and Clinical Operations to complete associated publications, reviews draft publications*.

·         Keeps all partners abreast of projects progress throughout all applicable intervals

·         May also participate/coordinate collaborations with external stakeholders

(e.g. cooperative groups, other companies, etc.) on development and implementation of

approved clinical projects.

·         May coordinate, liaise with internal and external providers for data mining activities

·         Helps his/her manager provide data outputs requested for safety and/or other relevant sections of IND annual reports, if these sections and reports relate to assigned drugs and/or indications*.

·         May interact with NCI or other agency, as appropriate, with supervision from his/her manager

¿ Stays abreast of internal and external developments (scientific, clinical, commercial, competitive, legal, regulatory and like) as such developments may implicate or otherwise impact the implementation of the medical plan of the assigned drug(s)/indication(s). Includes attendance at major scientific conferences, participation in competitive intelligence activities, and review of published literature

Provides clinical oversight for a variety of projects, in consultation with his/her Medical Director or Senior Medical Director :

·         Works with a host of internal and external partners and stakeholders in the implementation of clinical trials for assigned drugs/indication

·         Provides scientific input into and/or coordinates the development of specific clinical trial documents for review and discussion with Medical Directors* (e.g., protocols, charters, safety monitoring plans, process documents, etc.) including disease and/or treatment registries

·         Participates in the identification of appropriate external investigators

·         Oversees the clinical trial implementation, ongoing monitoring and evaluation, working closely and regularly with external investigators and Clinical Operations. Active Member in Study Management Team for assigned drugs/indications

·         Develops and cultivates relationships with external partners such as clinical investigators, clinicians, scientists and KOLs, as well as cross-functional partners in Clinical Development, Commercial, Legal and Regulatory.

·         Supports his/her manager in developing clinical components of presentations* for clinical trial investigator meetings

·         In collaboration with his/her manager, coordinates the preparation and reviews data outputs for reporting documents* where appropriate (e.g. clinical study reports, analysis plans, etc.) with the CRO, the Medical Affairs Biostatisticians and his/her Medical Directors

·         Monitors project progress and is expected to proactively identify any issues or challenges and recommend and implement strategies to effectively resolve such once approved with his/her manager

·         Works closely with his/her manager, the publication team and Clinical Operations to complete associated publications, reviews draft publications*.

·         Keeps all partners abreast of projects progress throughout all applicable intervals

·         May also participate/coordinate collaborations with external stakeholders

(e.g. cooperative groups, other companies, etc.) on development and implementation of

approved clinical projects.

·         May coordinate, liaise with internal and external providers for data mining activities

·         Helps his/her manager provide data outputs requested for safety and/or other relevant sections of IND annual reports, if these sections and reports relate to assigned drugs and/or indications*.

·         May interact with NCI or other agency, as appropriate, with supervision from his/her manager

¿ Stays abreast of internal and external developments (scientific, clinical, commercial, competitive, legal, regulatory and like) as such developments may implicate or otherwise impact the implementation of the medical plan of the assigned drug(s)/indication(s). Includes attendance at major scientific conferences, participation in competitive intelligence activities, and review of published literature

The TrackWise Center of Excellence is looking for a highly skilled Computer Systems Validation (CSV) and Software Quality Assurance (SQA) analyst able to perform within the multicultural team supporting numerous GxP TrackWise processes.  We are seeking an expert in GxP computer validation, 21 CFR Part 11 and Annex 11 requirements, and possessing excellent interpersonal, communication and critical thinking skills.

Job Responsibilities:

• Provide estimates and forecasting for CSV and SQA project resource needs
• Assist in developing and approving computerized systems requirements and functional specifications
• Create GxP deliverables such as validation master plans, test plans, installation, operation and performance qualifications (IQ\OQ\PQ), test scripts, validation summary reports, risk control strategies and risk assessments for changes to validated systems
• Conduct system testing for emergency, and maintenance and enhancement releases
• Document and provide feedback to development teams on issues and bugs identified during testing
• Maintain accurate bug tracking and issues resolution logs
• Develop and execute manual and/or automated test documentation in accordance with approved processes and established standards, and in compliance with applicable regulatory expectations 
• Document test results and work with development teams to resolve test deviations; perform root cause analyses
• Develop new processes and process improvements
• Coordinate with cross-functional teams including Quality to ensure accuracy of all testing documentation
• Partner with development teams to support installation activities and configuration management
• Escalate issues and deviations as needed to management
• Provide subject-matter expertise on software quality assurance best practices, regulatory expectations and 21 CFR Part 11 and Annex 11 requirements
• Liaison with Quality to ensure compliance with corporate policies and procedures (SOPs)
• Oversee contract validation personnel
  
  

• Serve as the Site Manager overseeing clinical contract manufacturing organizations (CMOs) or clinical distribution organizations (CDOs) that are needed to meet clinical supply requirements in supporting clinical labeling and packaging. 
• Lead and collaborate with cross-functional teams of subject matter experts to achieve business, operations, and quality objectives in addition to performance goals for the contract manufacturing or business partnerships.
• Manage the operational activities of the CMO ensuring program cost, quality, metrics, delivery and technology objectives are met as well as manage the partner performance to achieve them. 
• Develop solutions to complex issues with inter-organizational impact.
• Prepare Requests for Proposals (RFPs), Statements of Work (SOW) and negotiate supply agreements for clinical programs.
• Support development and continuous improvement of the supply relationship with IMP CMOs/partners.
• Position may be filled as an E3 or E4 depending on candidate’s experience and qualifications.

Responsibilities:

• Responsible for overseeing execution activities of clinical contracting manufacturing organizations (CMOs) to support labeling and packaging outsourcing activities for clinical studies. Scope is from release of DP at the Filling site through release of Final Packaged Goods at the label/pack site; scheduling and oversight of label/pack execution activities at the label/pack site; and ensuring the necessary DP materials and FG components are available for execution.
• Ensure reliable supplies of Final Packaged Drug Product (including Other Study Drugs as required) to our customers and our patients, while meeting acceptable quality standards and Genentech’s financial and development goals.  Proactively intercede if goals and timelines are jeopardized.
• Coordinate operational activities with internal cross-functional teams (Clinical Planning, External Quality, Distribution) to ensure on time release of packaged clinical product.
• Participate on cross-functional teams in evaluating and selecting CMOs for a particular project as requested. 
• Prepare a Statement of Work (SOW) as required.  The preparation of an SOW can include negotiation of project fees, negotiation of milestones, defining responsibilities between Genentech and the CMO and keeping Legal, Procurement and other groups up to date on SOW progress.
• Provide input to the internal CMO/partner SPOC ensuring that the overall relationship between Genentech and the CMO/partner is healthy. 
• Develop, maintain and drive key health metrics between GNE and the CMO to ensure effective and continuous improvement of business performance and relationship.
• Participate in Master Service Agreement creation and maintenance as requested so that it accurately reflects the existing business relationship.
• Proactively identify risks.  Create strategies to avoid or minimize their impact.  Manage the execution of risk mitigation plans. Participate in and contribute to drug development telecons in an effort to proactively intercede if a relationship issue jeopardizes the project.
• Create purchase orders.  Review and approve invoices for GNE payment and coordinate on-time CMO payments.  Develop annual CMO budget (expense and capital) and monitor performance against plan on an ongoing basis.
• Serve as the manufacturing outsourcing team leader on cross-functional teams as requested in support of clinical finished good packaging.
• Report as needed on performance and operations at Operations Review.
• Support External QA in establishing QA agreements with all CMO’s and assuring that Product Specific Requirements (PSR’s) are established before projects are initiated.
• Apply advanced theory, technical principles, expert judgment, and cross-functional expertise to independently address a broad range of complex problems.
• International and domestic travel as required. 

Requirements:

• Collaborative Leadership - Ability to strongly influence with or without authority, facilitate groups with diverse perspectives, bring teams to consensus/alignment.  High tolerance for ambiguity, able to create order from chaos.
• Ownership and Accountability – Takes accountability for actions, drives results, learns from mistakes.  Is direct and truthful and therefore widely trusted – delivers on promises, goals, and expectations.  Makes quality decisions and resolves problems rapidly.
• Communication - Ability to communicate effectively at all levels of the organization, teach and present complex and/or new ideas with clarity and simplicity.
• Planning/Organization - Excel...

The position:

The Senior Engineer in the Process and Project Engineering Group in the South San Francisco Production Technology Department will be responsible for Process Engineering (Process Equipment Design) and Project Management of Drug Product projects for the SSF Production Business Unit.   The support areas include commercial and clinical filling lines, inspection and clinical packaging.  The candidate must also provide mentorship and direction to partner MSAT groups on execution of process engineering design and project management.  In addition, the candidate will provide Process Engineering services such as approval of P&ID changes, IQ, Material of Construction forms, Engineering Design Review and Engineering Change Records.  The candidate will be responsible for development of business systems to support efficiency and sustainability.  The candidate will also help provide strategic direction to transformation of the Drug Product manufacturing capabilities.

• Follows all laws, regulations and policies that govern the conduct of all activities. Is accountable for being fully knowledgeable of all relevant policies and for abiding by these
• Does not compromise ethics or integrity, or undertake legal risks while pursuing business goals
• Asks questions when in doubt
• Demonstrates leadership among peers and subordinates by consistent application and modeling of the appropriate compliance, behavior and conduct
• If applicable, is required to obtain and maintain full proficiency and knowledge of disease state, product and other aspects or issues as provided for and mandated by the company

2. Planning & Development

• Act as a subject matter expert and a lead contact for FOIM Data Management – Field Operations IMS data sources and Genentech supplemented files production processes and projects
• Stays abreast of Commercial Operations and other business developments, to include external marketplace changes/developments, and uses where appropriate data to support recommendations to improve processes
• Recommends new opportunities to his/her manager and other business partners/stakeholders. Where approved, leads the development/implementation process for such new opportunities
• Works with manager, team members, gCOI, others in FOIM, other internal customers, partners and stakeholders and external vendors to review business requirements for Commercial Operations validation and sales data and plan for any new or updated data sources, systems, databases, interface, processing methods and/or reporting mechanisms
• Works with manager, team members and others to develop appropriate departmental plans and goals to address customer requirements. Where applicable, develops detailed project plans and participates in evaluating necessary resources 
• Participates in other planning and development meetings within FOIM and other Commercial Operations groups
• Participates in departmental policies & procedures development, which may include development and documentation of Standard Operating Procedures (SOPs) or other relevant guidelines. May take the lead role in departmental policies & procedures development, as assigned
• As appropriate and assigned, independently leads departmental or customer projects 

Analytical Operations provides assay support for Process Technical Development in GMP and R&D environments.  The hire will be mainly responsible for performing HPLC, CE and LC/MS assays, data processing, and development of HPLC methods. Responsibilities also include assay reagent and instrument maintenance, and assay troubleshooting.  Position requires working closely with other members of the department in a team setting, as well as extensive interaction with other departments. Handling of biological and chemical reagents is required.

We are recruiting for the position of Service Provider Strategy Lead to join our international Product Development Quality Assurance (PDQA) team.

Reporting to the Team Lead for Service Provider QA Strategy the ideal candidate will be responsible for the design and implementation of the Service Provider risk management and audit strategy across the GLP, GCP, GPVP areas. The role works in partnership with Procurement/Outsourcing Functions and the PDQA GLP, GCP, PV Strategy Leads to ensure that Risk Assessments are maintained across the inventory of Service Providers engaged globally (gRED, pRED, PD, GPS/gMED) and at Affiliate Level. 

This role monitors activities outsourced to Service Providers through periodic risk assessment, risk-based routine audits and provides ongoing support to mitigating actions. It also provides actionable data to Senior Procurement/Outsourcing functional management based on analysis of data (audit/inspection/risk) and identification of trends.

The ability to influence business partners in the area of service provider risk and quality management is essential to proactively identify and address issues with the skill to ensure that service provider quality issues are addressed in a timely manner and that the relevant management functions in the organizations are kept informed.
Key responsibilities and tasks:

• Design and implement the PDQA Service Provider risk-based strategy for risk management and audit activities
• Define/maintain the “audit/risk universe” of Service Providers based on input from Procurement/Outsourcing functions and PDQA GxP Strategy Leads
• Partner closely with the GxP Strategy Leads, Procurement/Outsourcing Functions to ensure that risk assessments are maintained for Service Providers to determine which audits will be conducted and where risk mitigation activities should occur. 
• Develop and implement a GxP risk based strategy to deliver an audit program and quality oversight model for service providers within service category areas. 
• Assess specific risk areas on an on-going basis, communicate to PDQA senior leadership and propose modifications to PDQA strategy where necessary 
• Develop and maintain risk assessment tools 
• Assess data/metrics from audits, inspections and risk management activities for compliance trends and risks 
• Develop communication tools (reports/dashboards) for audit and inspection metrics and trends
• Escalate significant compliance issues to PDQA Management
• Represent QA on Service Provider sourcing initiatives and Strategic Alliance or Category governance teams, participating in Service Provider due diligence visits where appropriate.
• Support regulatory authority GCP inspections at service providers.
• May lead or participate in GCP audits at service providers
• Provide leadership and direction to PDQ/PDQA and our customers/stakeholders on GxP related activities/issues related to Service Providers  
• Establish strong partnership/relationship with key stakeholders in Procurement and Outsourcing functions
• Review and provide feedback on service category area risk mitigation plans/CAPAs
• Provide quality leadership on complex issues (i.e., CHD) to Procurement/Outsourcing functions and PDQA staff
• Represent QA on Service Provider Strategic Alliance or Category Governance teams.
• 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 knowledge of GLP, GCP, PV regulations and internal policies and SOPs  
• Maintains highest level of awareness and expertise in international GxP/PV regulatory requirements, guidelines, and policies, and applicable Roche/Service provider SOPs and project-specific procedures. 

The Biomarker team in Early Development has an opening for a summer intern.

Responsibilities may include but are not limited to the following:

Evaluate and develop methods for capture and molecular characterization of circulating tumor cells (CTCs) . 

1- develop methods for identification of CTCs of epithelial and non-epithelial origin, and algorithms for automatic detection of CTCs.

2- evaluate diagnostic markers on CTCs using imaging methods (IF, ICC). 

3- develop methods to isolate single CTCs and evaluate downstream molecular analysis platforms.

The Country Study Manager (CSM) provides leadership to one or more Study Management Teams (SMTs) and provides strategic planning and organization to achieve successful study completion. The CSM maintains full ownership of the US Medical Affairs portion of a study and ensures the effective and efficient delivery of the operational aspects in accordance with the medical plan and ICH/GCP standards, Roche SOPs, local operating guidelines and local regulatory requirements. The CSM also ensures the development and maintenance of productive relationships with our customers.

Responsibilities:

- Provides Direction and Leadership to one or more SMTs

- Establishes Study Timelines, Budget, Resource, Risk and Quality Plans

- Manages the Delivery of Study Activities in Order to Meet Study Plans

- Builds effective, high performing SMTs through influence, integration, motivation and optimization of team performance.

- Develops and maintains effective working relationships with, and is the primary contact for, key stakeholders, eg, Pharma Business

- Functions as Study Management Team Leader.

- Maintains awareness of external clinical research practices to ensure the SMTs are aware of the risks, priorities, value and impact of their work and contributions.

- Provides input into the study synopsis, development of the final protocol, feasibility conduct and all study specific documents and procedures.

- In accordance with the overall medical plan, establishes and maintains accurate study level plans in designated resourcing and planning system.

- Is accountable for the development and active management of the study patient recruitment strategies in US Medical Affairs.

- Develops Partnership with Business, participates on local life cycle teams, consults local Business Units, and participates in local Business Unit meetings as necessary.

- Is accountable for the selection, training and direct management of external suppliers supporting US Medical Affairs trials.

- Ensures that data is delivered in accordance with established dataflow timelines.

- Develops/maintains investigator relations, builds and maintains a professional relationship between Roche and Investigator, participating in Investigator Meetings as necessary.

- Monitors progress against SMT goals and takes appropriate action to ensure goals are met and issues are communicated with the appropriate persons or teams.

- Oversees the management of the Clinical Operations studies budget.

- Leads the evaluation of standards across one or more SMT(s) with the objective of enhancing quality, productivity and efficiency. 

This position  may be filled at a Strategy Manager or Sr. Strategy Manager level. 
 

The Strategy Manager is responsible for maximizing the value of Genentech's portfolio through the development of integrated pricing and contracting strategies for a specific therapeutic area or product(s). The role involves leading cross-functional strategy development teams, building effective relationships across all GNE franchises, scenario analysis/modeling for overall financial and legal viability, as well as ongoing contract performance assessment/analysis. Position involves extensive cross-functional collaboration with brand teams, Market Planning, MCCO Account Managers, Government Affairs, Health Economics and Global Pricing and Payer Planning.

• Conducting detailed analysis and constructing presentations to support recommendations to senior management on specific pricing actions for new and in-line products.
• Provides a leadership perspective on GNE pipeline pricing assessments for inclusion into payer planning activities, revenue forecast development, and decision-making.
• Works with internal/external partners/stakeholders to conduct regular market research
• Evaluating macro-trends in the healthcare environment that could potentially impact pricing and contracting opportunities and/or risks
• Provides business partners/stakeholders with in-depth analyses, modeling and optimal scenarios needed to determine the best contracting strategies to meet GNE objectives
• Works closely with partners in field Account Management to understand payer/channel customer needs, expectations, challenges, etc.
• Complies with all laws, regulations and policies that govern the conduct of GNE activities

(Note: This description is not intended to be all-inclusive.)
Perform routine cleaning and custodial maintenance duties:
Execute required order of cleaning in a GMP environment.
Be able to execute all documentation required for cleaning in GMP environment.
Maintain floor surfaces (epoxy, Concrete, rubber tile, and sheet vinyl) by scrubbing, stripping, waxing, buffing, sweeping, wet mopping, and dry mopping these floor surfaces.
Operate floor cleaning machines, buffer, scrubbers and Zamboni.
Operate scissor lifts and fork lifts.
Maintain manufacturing areas by cleaning and disinfecting floors, walls and ceilings as required by cleaning documents.
Maintain stainless steel and windows in GMP areas.
Collect and dispose of garbage, including recyclable materials and some hazardous waste.
Move furniture as assigned when necessary.
Maintain bathrooms by cleaning and disinfecting sinks, mirrors, urinals, toilets, showers, and walls when necessary.
Perform miscellaneous tasks including cleaning venetian blinds, fans, humidifiers, windows, walls, drinking fountains, and garbage cans; polishing brass and stainless steel; replacing light bulbs when necessary.

Perform outside maintenance tasks:
Perform snow shoveling and sweeping of sidewalks and stairs when necessary.
Apply deicer to sidewalks and stairs when necessary.