Regulatory Program Management is part of the broader PDR organization that interprets the needs of worldwide health authorities and provides regulatory intelligence necessary to generate and present information that meets the needs of health authorities, patients, purchasers and prescribers for Roche’s global Pharma Medicines Division, which includes all therapeutic areas and all phases of product development from early development to post-marketing. PDR is responsible for the timely submission of applications to health authorities for approval of new products and line extensions. PDR is committed to regulatory strategies that are the most innovative, ethical, and influential in the industry. Like others in Regulatory Program Management, Program Directors are assigned their responsibilities by therapeutic area, and are assigned projects for different product development phases, as business needs dictate. Regulatory Program Management Program Directors provide regulatory leadership for one or more regional or global development projects. Regulatory Program Management Program Directors are responsible for the development and implementation of regulatory strategies to facilitate the development and approval of Roche medicines for human use. Program Directors are expected to lead more complex projects and represent PDR to cross-functional teams and groups with increased independence. Regulatory Program Management Program Directors are responsible for working cross-functionally and coordinating regulatory-related activities across PDR functions and with other internal partners.  Regulatory Program Management Program Directors serve as the principal interface with primary reviewers from health authorities and for other interactions with relevant regulatory-related external parties; managing the strategies for and execution of these interactions.

DUTIES & RESPONSIBILITIES:

• Continues to expand his/her knowledge base of laws, regulations and guidelines governing the development, licensure and marketing of drugs and biologics.  Briefs teams and management, as appropriate
• Obtains and applies in-depth knowledge of Roche and regulatory guidelines, procedures and best practices
• Provides regulatory expertise and leadership to site, regional or global cross-functional teams and other groups
• Stays abreast of therapeutic area product development and other related business strategies and plans 
• Serves as the primary PDR representative on one or more regional or global projects at any one point in time; typically complex projects
• Analyzes data, the regulatory environment and business objectives to recommend priorities
• Leads teams in developing, implementing and delivering the cross-functional regulatory strategy for each project or related assignment.  Plays a lead role in helping ensure effective balance of time, cost, quality and risk so that regulatory strategies meet the needs of patients, prescribers, payers, regulators and Roche
• Plays a key role in assuring business objectives are understood and taken into account during regulatory strategy development
• Identifies and aligns cross-functional regulatory resources necessary to execute the regulatory strategy for each project or related assignment
• Works with others to ensure timely and appropriate cross-functional alignment and appointment to RAFT for each assigned project
• Presents and obtains approvals for the cross-functional regulatory strategy to various teams, committees and senior management
• Serves as the site, regional or global principal interface with primary reviewers from regulatory authorities or for other regulatory-related interactions with other external parties. Establishes effective working relationships with regulatory authorities and directs regulatory interactions for internal site, regional and/or global teams
• Provides internal teams with direction on regulatory authority interactions
• Manages ongoing RAFT meetings. Including providing ongoing leadership of regulatory deliverables and guidance on compliance, timing and other relevant matters.  Manages RAFT resources
• Ensures cross-functional perspectives and expertise are incorporated into regulatory plans prior to decisions being made
• Manages decision-making and conflict resolution surrounding regulatory issues within cross-functional teams, including coordination between other business teams and RAFT team. Ensures appropriate escalation to team leaders or functional management, as necessary 
• Oversees, coordinates and provides a first-line of internal approvals for regulatory submissions and other relevant regulatory documentation
• Responsible to ensure all PDR deliverables associated with each project or other assignment are completed within defined timelines and...

Summary of Position:

The Clinical Safety Associate I (CSA I) assists in the clinical processing of adverse event (AE) information received by US Pharmacovigilance (USPV).  Responsibilities are performed under the direction of the USPV Manager. 

Job Duties/Responsibilities:

• Demonstrated knowledge of safety concepts, per ICH and FDA guidelines per drug safety reporting requirements.
• Performs a review of ancillary documentation accompanying ICSR reports and identifies pertinent clinical information for incorporation into the case narrative.
• Performs Data Capture and Quality Review for all molecules and serves as a back up for additional projects.
• Identifies and initiates requests for case follow up for clinical trials and post marketing adverse events.
• Works with Submissions Team Responsible to properly identify US regulatory reporting requirements.
• Demonstrates a general understanding of appropriate labeling documents for assigned project(s).
• Demonstrates knowledge and understanding of safety exchange agreements (if applicable).
• Participates on Study Management Teams (as applicable)
• Assists in the development of drug safety presentation for investigator meeting presentations.
• Assists in clinical trial reconciliation process (as applicable).
• Organizes work load to ensure compliance with regulatory timelines for ICSR reporting.
• Ensures departmental workflow processes and timelines are followed. 

Competencies Identified for Success:

• Works effectively as a team member and promotes collaboration
• Demonstrates initiative and accountability
• Strong organizational skills, detail oriented, ability to adapt to change
• Confident decision maker

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

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 Preclinical and Translational PK/PD Department at Genentech,Inc. is seeking a Ph.D. level scientist who is driven to understand the pharmacokineticsand pharmacodynamics of novel drug candidates with a focus on proteintherapeutics including antibody drug conjugates. This individual will beresponsible for investigating the pharmacokinetics, biodistribution, and PKPDrelationships of novel therapeutics in preclinical models to identify leadcandidates for further development, and for all relevant translational aspectsbridging preclinical PKPD information to patients. This individual will beresponsible for the PK and PKPD strategy to support preclinical development andfirst in human regulatory filings, including planning, designing, analyzing, interpretingand reporting PK and PKPD studies. This will be accomplished by working inclose partnerships across various functions including Research, DevelopmentSciences, Clinical Sciences, Biostatistics, and Regulatory. This individualwill represent the department on cross functional project teams as the PKPDrepresentative and/or pharmacology sub-team leader. An additional componentwill be the presentation of PK/PD results at cross-functional teams, departmentmeetings, review committees, conferences and regulatory meetings.

Department:                       Pharma Technical Regulatory (PTR)

Job Family / Category:      PTR Regional Hubs

Position:                             PTR Regional Hub Sr. Regulatory Associate

                                           PTR Regional Hub Regulatory Manager

Location:                           Tuas, Singapore

Purpose

This position will be responsible for execution and management of regional life-cycle submissions for all Roche products as well as new product registrations by focusing on local needs of Affiliate Drug Regulatory Affairs (DRA) teams to ensure right first-time submissions to Health Authorities.

Responsibilities:

* The incumbent will be the primary technical regulatory (CMC) point of contact for the Affiliate DRAs and as such he/she will work closely with them and the regional Supply Chain teams as well as with the PTR product managers and the PTR network.

* In coordination with global PTR Technical Regulatory Leaders (TRL), execute regulatory strategy for lifecycle submissions in Asia Pacific markets associated to management of CMC changes originating at manufacturing sites or affiliates toward maximizing efficiency, quality and rate of submission approvals by Health Authorities.

* Coordinate strategic planning with Regional Supply Chain and Affiliates DRA for change management alignment and early visibility/communication/planning of changes impacting markets in the region.

* Assemble lifecycle submissions for markets under responsibility to guarantee right first time submissions and coordinate/manage with affiliates for timely and effective submission of changes to the Health Authorities.

* Act as subject matter expert in regulatory requirements for post approval submissions and maintain the regulatory intelligence repository for regional markets under responsibility.

* Ensure timely update of the CMC change management electronic systems with the regulatory information submitted/approved externally by a Health Authority or internally by the appropriate functional area.

* Upon request, support Affiliate DRA with interactions with regulatory authorities to facilitate the prompt review and approval of submissions (CMC content Subject Matter Expert).

* Manage timely responses to Health Authority questions resulting from lifecycle submissions in regional markets under responsibility.

* Manage tracking of commitments with a Health Authority as result of license/dossier approval and ensure commitments due dates are met.

* The candidate may be required to travel to other Roche sites on a periodic basis.

Senior Project Manager – IT

The Senior IT Project Management position will be responsible for leading the delivery of technology projects in support of US Commercial Operations. The Senior IT Project Manager is accountable for the successful delivery of technical solutions through effective planning and execution throughout all phases of our project management methodology. The Senior IT Project Manager will be responsible for managing assigned resources, effectively tracking budgets and financial forecasts, creating and tracking detailed project plans, effectively leading and facilitating project meetings as well as proactively controlling project scope, risks and issues. This position is expected to provide timely status reports to all stakeholders and escalate issues to the appropriate management level. The Senior IT Project Manager will be accountable for all projects in the Commercial Compliance Solutions portfolio, either through direct management of projects or by sourcing and overseeing contract Project Managers. 

Duties:

* Define, plan, and direct the execution of a broad range of technical projects, while balancing the competing demands of scope, time, cost, quality, resources, and risk

* Identify, acquire, and lead multifunctional project teams

* Manage a portfolio of projects, in addition to individual projects assigned to the position

* Ensure project objectives/requirements are clear and agreed to by all stakeholders

* Manage relationships with various technology and business communities to achieve 

project objectives

* Facilitate project management activities across the entire project management methodology

* Establishes and maintains effective communication for assigned projects and with dependent projects

* Ensure successful and timely completion of deliverables

* Track progress against baseline schedule

* Plan, baseline and control costs to ensure projects are completed within approved budget

* Identify and apply systematic quality activities to ensure that projects employ all 

processes needed to meet Computer System Validation directives

* Suggest improvements where necessary / appropriate to improve operational efficiencies

* Conduct risk management planning, identification, analysis and monitoring on projects

* Formulate risk mitigation strategies and recommend solutions

* Manage the processes required to ensure timely and appropriate generation, collection, distribution, storage, retrieval, and ultimate disposition of project information and documentation necessary for successful communications across all stakeholders and any required updates to living system documents for validated systems

* Other duties as assigned

A multi-talented Informatics specialist in San Francisco is needed for the Global Pharma Informatics Safety Risk Management team. In this role you will work closely with the Business System Owner, users, development and support teams, vendors and service providers to provide an excellent service for the Drug Safety Systems globally. 

A true multi-talented professional is required – willing to play multiple roles as required within a dynamic global team – to ensure optimal support, service and application delivery to our internal customers.  You will act in multiple capacities such as service manager, solution life cycle manager and business analyst. Activities you are likely to be doing in this role are (but not limited to):

• Ensure Support globally is seamless and following our Global Support Model  - your primary responsibility will be the users in the Americas (North, Latin and South America), however you and your team may need to deal with critical incidents not resolved by the team located in the EU.
• Work in close collaboration with other Delivery Service Managers to ensure global support and prioritization of incidents and assignments
• Work closely with business users, business system owner and informatics to keep all stakeholders abreast of any significant impact and changes to the systems.
• Ensure the validated state of our systems and ensure compliance with applicable SOPs and policies governing the systems and processes.
• Provide business process support by understanding existing business processes, and offering advice, implementation of changes or reconfiguration to meet business objectives.
• Provide technical support and trouble shooting for our Safety Risk Management applications.
• Work in collaboration with business to identify business solutions and requirements for new functionalities, and performing impact analysis on systems and processes, and potential ongoing projects
• Work with vendor/service providers to ensure compliance with SLAs and support in service improvement initiatives.
• Develop excellent relationships with all layers of business
• Participation in systems projects
• Openness to take on new tasks and challenges outside the formal role description corresponding to skills and capacity

Purpose: 

The Safety Science Leader (SSL) is accountable for all aspects of safety related to a product in the Life Cycle Team (LCT) stage including single case assessment, aggregate reporting, signal detection, risk management throughout the life cycle. The Safety Science Leader leads product specific safety analyses including medical evaluation, risk management, signal detection using epidemiology and other input as appropriate. Accountability is partially exerted by the bringing of safety topics to the Development Subteam (DST) and, when appropriate, the Life Cycle Team (LCT) to ensure that adequate safety measures are implemented, based on data, and that CIOMS 6 guidelines are followed. 

Primary Responsibilities and Accountabilities:

• Contributes to scientific publications (abstracts, posters, papers) for scientific meetings/journals and approves submissions from a safety perspective. 
• Reviews all communications to the public from a safety point of view. 
• Keeps the EU QPPV fully informed of any changes to the benefit-risk relationship and, where appropriate, performs tasks as delegated by the EU QPPV. 
• With the CSL and the DST, plans and performs, on an ongoing basis, an evaluation of the safety data to detect safety signals. On an ongoing basis with the team, evaluates the Benefit/risk relationship of the program and determines how to manage patients within and across trials.
• Is accountable for safety components of all NDA documents. 
• Is responsible for the writing and maintenance of RMP/REMS NDA documents. 
• Represents Roche in interactions with Health Authorities and Independent Data Safety Monitoring Boards (ie Pre-BLA/NDA meetings, advisory committees) for safety related topics.  
• Contributes to and where specifically delegated may be responsible for the proper execution of the post-approval RMP/REMS 
• Ensures that all safety processes are properly supported and compliance is documented for all studies conducted by PD or PB or affiliates. 

People Leadership: 

• Provides provide leadership and line management to the Safety Sciences department across multiple locations, aligning with other parts of the organization, where necessary. 
• Ensures that the performance of direct reports is proactively managed and that they are coached, trained and developed to maximize their contributions.  
• Allocates resources and is accountable for the assignment of his/her collaborators / reports according to their individual capabilities and in line with projects priorities.
• Ensures that staff communication and employee relations are managed proactively to maximize the well being of employees. 
• Actively installs the Roche values in the Safety Team and their activities.

Note: Position can be filled as a QC Pharmaceutical Specialist II (E4) or Sr. QC Pharmaceutical Specialist (E5) based on education and experience.

QC Pharmaceutical Specialist II Role
The QC Pharmaceutical Specialist is a member of the senior technical staff of the QC Microbiology/Environmental/Molecular team specializing in microbiological challenge studies (i.e. disinfectant efficacy testing, antimicrobial effectiveness), sterility testing method and isolator validation, as well as deviation assessment/management.

Main Purpose of the Position:   
• Develop solutions to complex Quality Control testing activities and issues and Quality initiatives with inter-organizational impact following cGMP regulations and Genentech 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.
• Follow proper safety precautions and laboratory technique in the use of reagents and other chemical compounds, including but not limited to acetonitrile, chlorine, acids and bases, biologic toxins, microorganisms and potent compounds.
• 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.
• Meets scheduled performance of 95% on time.
• Perform any other tasks as requested by Management to support Quality oversight activities.

Technical Duties/Responsibilities:
• Provide technical expertise in the development of test method validation protocols and supporting procedures.
• Ensure validated methods and supporting procedures adhere to approved regulatory specifications.
• Prepare validation summary reports for test method validation activities.
• Provide input into regulatory filings.
• Perform Quality Control testing for product release and stability samples.
• Support quality investigations for testing and test method discrepancies.
• Perform equipment validation for laboratory instruments used in cGMP testing activities.
• Provide input into the generation of stability study protocols.
• Collaborate with departments to ensure product release and stability testing requirements are completed.
• Communicate testing or scheduling issues that may impact the timely release of final product to Quality Control Management.
• Compile trending reports for method validation and testing activities.
• Develop and deliver training materials for new and revised test methods and laboratory procedures.

The Discovery Oncology department is seeking an exceptional and highly motivated scientist to join a team focused on the discovery and validation of novel oncology drug targets and the discovery of biomarkers predictive of the clinical efficacy of novel cancer therapeutics. Current efforts of this team are largely directed to developing a mechanistic understanding of tumor cell sensitivity and resistance to molecularly-targeted anti-cancer agents. Aspects of cancer cell biology of particular interest include epigenetic regulation and intra-tumor heterogeneity.

MSDs are generally expected to perform their responsibilities with limited guidance from Medical Directors and/or other relevant internal partners and stakeholders:

·         Implement the medical affairs plan for the assigned drug(s) /indication(s), working with Medical Directors, mainly on PhIV clinical programs and their publication plans

·         Collaborates with Commercial and provides scientific input for the development and review promotional materials, documents and presentations developed for the assigned drugs and/or indications (signing off of any promotional material remains the responsibility of the Medical Director of the assigned drugs and/or indications)

·         Support his/her manager, as and when requested, in developing relevant parts of the medical affairs tactical plans, and/or completing other special projects such as preparation and review of training materials for field forces

·         Demonstrate ever-increasing competence in implementations of all aspects of medical plans

·         Competently and collaboratively interact with a host of internal and external partners and stakeholders

·         Consistently complete all assigned responsibilities on-time and on-target.

·         Develop and cultivate important relationships with internal and external partners and stakeholders. Includes investigators, thought leaders and KOLs (key opinion leaders)

·         Stay informed and abreast of the external landscape as it relates to assigned drugs and/or indications and the associated therapeutic area(s)

JOB DESCRIPTION - PRIMARY DUTIES AND RESPONSIBILITIES:

1. Clinical Trials & Programs 

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 GNE Medical Affairs, 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...

• Acts as a subject matter expert and specialist point-of-contact for internal staff and management and external vendors involved in the distribution and/or administration of Genentech promotional goods:

• Receives and reviews all incoming requests/inquiries
• Reviews incoming promotional goods requests or other inquires in accordance with governing rules, regulations or other policies and procedures to ensure consistent and full compliance
• Provides timely responses and other information to internal and external customers, partners and other stakeholders
• Enters all requests and other information into appropriate departmental or other systems or databases
• Responsible to ensure that departmental systems and/or databases contain current and fully accurate information
• Performs routine and ad hoc analyses and reporting

• In partnership with Vendor Manger, visits promotional goods vendors and
• performs compliance and other operational audits
• Performs routine and ad hoc audits on promotional goods distribution managed by Genentech field staff and management
• Produces audit reports. Reviews with manager and others. Distributes to various parties.  Identifies and communicates potential or existing issues and recommends steps and activities to mitigate risks of non-compliance or other potential concerns
• As and when appropriate, participates in various meetings or conference calls to determine promotional goods needs, requirements, and/or communicate new or updated regulations, policies, procedures or other changes
• Supports manager and other team members, as and when/how needed, to cover for any staff shortages within the department
• Works with manager and other team members to continuously review department processes, procedures, tools and other resources to ensure best practices, optimal efficiencies and effectiveness
• Supports his/her manager and other team members in ongoing training, mentoring and coaching of less experienced analysts
• Complies with all laws, regulations and policies that govern the conduct of Genentech activities

Location: San Francisco

Research, Facilities, and Procurement Services

Primary Purpose of Job (Job Summary)

The Category/Souring Manager, Facilities Procurement is to provide strategic leadership to the Facilities Procurement organization in support of Global Categories related to Facility Operations and Services.  This position is responsible for: establishing full strategic planning (Regionally and interfacing Globally) on behalf of the Facilities Procurement function in alignment with the Pharma Business and Corporate goals and objectives; identifying and introducing best practices in the Facility Procurement processes; acting as a change agent who supports and influences the business in an effort to create value and efficiencies across the Global and NA Regional networks; focusing on return on investment benefits, Category Lifecycle Management and Total Cost of Ownership; evaluating savings opportunities in partnership with key business partners and stakeholders and maximizing the value of third-party services across a portfolio of sub-categories.  The Global/Regional Category Manager will lead cross functional teams through strategic category sourcing to deliver breakthrough business benefits.

Functional Roles & Responsibilities

The Global/Regional Category Manager, Facilities Procurement will have a Category Strategic and Supplier Management focus of assigned Global/Regional Categories related to Facility Operations and Services.  This position leverages category management expertise to manage the purchases of goods and services, with the aim of achieving optimal total cost of ownership.  This position provides end-to-end strategic solutions, from idea generation through to presentation to senior business management and initiative execution and will fully utilize the eSourcing tools including eAuctions when appropriate to drive the costs down and out across the assigned categories.

Responsibilities:

* Develop strong working relationships with internal teams, key business partners and leaders throughout the Global and Regional organizations/networks.  

* Partner with global colleagues to develop and implement the global category management roadmap.

* Build and maintain excellent relationships with key affiliates, Roche group companies, and global functions so that Roche collectively benefits (e.g. global savings, service delivery, vendor selection, etc.).

* Partnering with stakeholders and business partners to identify and support sourcing projects that reduce risk, timeline, stakeholder pain-points or cost and add value without sacrificing quality or effectiveness.

* Lead and/or partner with various multifunctional teams on strategic initiatives which also include accountability for implementation planning and tracking of expected outcomes.

* Aligning the priorities, activities, and progress of goals across the Facilities organization, so that high value and quality customer service is delivered.

* Provide Strategic Category and Supplier Management:

o Develop an advanced understanding of category subject matters to include Analyzing Category and Supplier Spend history, trends and forecasts

o Establish and manage robust Supplier Relationship Management programs for Strategic/Key suppliers

o Lead Category activities and Sourcing Managers in the development and execution of the spend category sourcing strategies for key initiatives.

o Develop detailed supplier knowledge, market data, including financial performance (P&L, balance sheet, debt structures, trends, history, executives, ownership, parent companies, size, concentration of sales to GNE, diversity of sales volume)

o Analyze past and future demand volumes, inventory trends and current inventory levels

o Document supply-chain for key goods and services

o Identify opportunities that focus on cost reductions, efficiencies/quality improvements, risk mitigation, industry and supply trends and shifts in technology

o Lead sourcing projects including sourcing strategy development, market analysis, and supplier negotiations, and supplier relationship management

o Monitor Strategic/key Suppliers (earnings, SEC filings, RSS feeds, Alerts) to provide internal notifications to key stakeholders that includes developing risk mitigation scenarios

o Ensure Diversity Suppliers are included in sourcing events

o Know, understand and stay abreast of industry trends, benchmarks, best practices, etc.  Develop and implement a strategy to gain competitive advantage.

* Facilitate senior level review and concurrence on sourcing strategies, including sponsorship and resource allocations.

* Demonstrate advanced industry knowledge and facilitation skills so that this role leads the negotiations of contractual requirements that includes managing complex RFP/RFIs, making sele...

Position description and responsibilities:

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

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

The PD Clinical Operations / Biometrics / Clinical Science Informatics team (part of FPPO) is looking for a senior Business System Analyst (BSA), with in depth Business analysis experience in the Pharma/Biotech industry and the ability to strategize, recommend and implement solutions with an end-to-end process filter that will meet the short and long term needs of Clinical Operations.

The senior BSA is responsible for exploring, scoping, planning and supporting the successful implementation of solutions by providing business analysis, best practice research, detailed requirements definition and user acceptance facilitation.

We are looking for an individual with strong customer focus, experience in working in global, multi-cultural environments, with a structured working approach and excellent analytical and communication skills. 

FURTHER RESPONSIBILITIES / DUTIES ARE:

• Participate and conduct strategic / exploratory workshops to identify / plan / execute innovation experiments and to contribute to robust roadmaps supporting the business strategy. Example: resource may participate to the Trial2Patients initiative 
• Collaborate with business and informatics stakeholders to lead business case development for new initiatives as well as business case tracking for completed initiatives.
• Plan early stage project efforts; specifically, requirements gathering, assessment and scoping, and project initiation and funding.
• Plan and facilitate workshops and end-user working sessions intended to surface requirements and validate designs.
• Take active role in preparing initiatives for portfolio committee and approvals at appropriate project milestones.  
• Collaborate with other BSMs / BSAs across functions and regions to identify and address business problems and opportunities, evaluate alternative informatics technologies and research industry best practices and emerging trends.
• Collaborate with Project Managers, Architects, Engineers, Developers, and Designers on scope, solutions, constraints, and risks
• Analyze document current and future business process models
• Take responsibility in ensuring the solution meets the customer needs. Support operational services teams in ensuring continued business value realization and business adoption.
• Collaborate with BSMs / BSAs within function and across functions to continuously harmonize and further develop skills and working practices specific to the BSM/BSA community within the organization 

Note: Position can be filled as a QC Pharmaceutical Specialist II (E4) or Sr. QC Pharmaceutical Specialist (E5) based on education and experience.

QC Pharmaceutical Specialist II Role
The QC Pharmaceutical Specialist is a member of the senior technical staff of the QC Microbiology/Environmental/Molecular team specializing in environmental/utility monitoring support for biotech drug substance production and aseptic filling.

Main Purpose of the Position:   
• Develop solutions to complex Environmental/Utility monitoring activities and issues.
• Lead Quality initiatives with inter-organizational impact following cGMP regulations and Genentech 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) for Environmental/Utility Monitoring 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.
• Follow proper safety precautions and laboratory technique in the use of reagents and other chemical compounds, including but not limited to acetonitrile, chlorine, acids and bases, biologic toxins, microorganisms and potent compounds.
• 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.
• Meets scheduled performance of 95% on time.
• Perform any other tasks as requested by Management to support Quality oversight activities.

Technical Duties/Responsibilities:
• Provide technical expertise in the development of test method validation protocols and supporting procedures.
• Ensure validated methods and supporting procedures adhere to approved regulatory specifications.
• Prepare validation summary reports for test method validation activities.
• Provide input into regulatory filings.
• Participate in internal and external audits and regulatory inspections.
• Perform Quality Control testing for product release.
• Support quality investigations for testing and method discrepancies.
• Oversee equipment validation for laboratory instruments used in cGMP testing activities.
• Identify, initiate and approve change records to GMP controlled documents and electronic systems as appropriate.
• Collaborate with departments to ensure product release requirements are completed.
• Communicate testing, scheduling, or Environmental/Utility Monitoring issues that may impact the timely release of final product to Quality Control Management.
• Compile trending reports for method validation, testing activities and Environmental/Utility Monitoring.
• Develop and deliver training materials for new and revised test methods and laboratory procedures.

The Advisor PEM advises and supports the Medical Unit Head of Operations. The Advisor PEM has the operational responsibility for the performance of assigned Medical Teams. This is a leadership role with responsibilities for providing input into design, development and execution of post-marketing activities; supporting medical teams in the mitigation of risks and the delivery of successful outcomes.  Advisor PEMs are assigned PEM responsibilities for multiple and/or complex or large-scale multiple molecules/products with potentially multiple indications. Advisor PEMs are also expected to take a leadership role in gMed initiatives, when needed, act as a substitute for his/her manager, assist his/her manager and others with on-boarding, training and coaching new PEMs, and if appropriate, have 1-2 direct reports.

Responsibilities:

The areas of major responsibility include, but are not limited to the following:

• Responsible for the day-to-day operations of the designated Medical teams.

o Works closely with medical directors and other cross-functional partners /teams to support the development of short and long-term medical strategy, plans, tactics, budgets and other resource plans for multiple and/or large-scale or highly complex molecules

o Co-leads and facilitates all medical team planning and decision-making

o Identifying and initiating problem solving strategies when operational issues arise and escalates issues if unresolvable.

o Plays a lead role, working with finance, legal and other partners to evaluate medical plans, develop budgets and determine any legal or other administrative implications or requirements necessary to execute projects.

o Works with team members and other stakeholders to ensure alignment of gMed strategies, plans and objectives with Genentech strategies.

o Co-leads process to develop the medical plan vision, strategy, scope, milestones, risk assessment and management strategies, project investment requirements and success metrics 

o Supports medical directors and/or plays a lead role in development and delivery of critical presentations to communicate, obtain inputs into and approval for medical plan strategies, objectives, tactics and resource requirements 

o Works with cross-functional medical team members and other partners/stakeholders to implement project plans to ensure timely, on-target, and within-budget execution

• Builds and maintains relationships with key internal/external customers, partners and other stakeholders, includes global partners, external strategic partners, etc.

• Works with manager and other team members on key departmental projects, including standardized gMed and/or MU specific Planning & Execution SOPs, other protocols, processes, systems, tools, etc. 

• Oversees all project/program phases to help ensure on-time, on-target and within-budget execution 

• Conducts proactive risk assessment and change control for all assigned projects/programs

• Complies with all laws, regulations and policies that govern the conduct of Genentech activities