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.

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.

• 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

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.

Position: Principal Business Process Excellence

Location: Basel or South San Francisco

Summary:

Team Overview:

The Business Process Excellence (BPE) team is focused on enabling GPP to achieve Best in Class Performance by taking the lead in the creation and improvement of scalable, robust, and streamlined processes.  Intent is to enable GPP’s Strategy and build robust process capabilities that manifest through the routine delivery of exceptional performance as per business needs. The BPE group partners with the business to deliver business results focused on establishing and improving business processes to improve reliability, increase simplicity, and enable growth. We use a several tools and methodologies within but not limited to Business Process Excellence toolkit to deliver tangible and sustainable business results. 

Position Overview:

This position focuses on using Business Process Excellence methodology to perform business process analysis, design/re-design and optimization to enable the routine delivery of exceptional operational performance

Reporting to the Head of Business Process Excellence - Global Pharma Procurement (GPP), the Principal- Business Process Excellence (BPE) will champion embedding Business Process Excellence across the entire GPP organization and ensuring our organization achieves its vision of becoming the Best in Class within the industry. Person will be simultaneously in a strategic and global execution role to support GPP’s journey towards the Best in Class performance.  Incumbent will partner with clients across GPP & PT on a regular basis, drive BPE cultural change and build BPE capabilities at grass root as well as leadership level.  

Responsibilities: 

This individual will be responsible for leading global cross-functional process improvement projects, representing the department as the change agent, partnering with the customers, leading internal efforts within the team, communicating/coordinating/bringing together key stakeholders, resolving conflicts within the team, and delivering real value-add sustainable cross-functional solutions. This individual will mentor project team members and staff in best practices associated with industry and BPE methodologies. This individual will be accountable for following and improving upon the BPE methodology. The work will be done in alignment with the company's values and behaviors. 

Requirements: 

* Lead cross functional project teams to: -Create solutions to ensure a continuous improvement culture, including behaviors and measurements using BPE methodology

* Implement practical and sustainable business processes that best serve the business unit -Deliver project goals on budget and on schedule

* Develop conceptual customer needs into an approved project charter

* Analyze business, process and systems performance, and identify improvement opportunities -Identify opportunities for team members to develop, evaluate and manage business case and cost/benefit analyses

* Make recommendations to Senior Management based on business case and analyses

* Lead decision making support and make recommendations regarding best options -Communicate proactively with stakeholders and senior management regarding progress, issues and plans for resolution

* Develop and use project plans to coordinate participants and track and report progress -Leverage industry research and analysis; serve as advocate, mentor & role model for integrating best practices into the organization -Ensure improvement methodology and tools are utilized effectively to maximize benefits

* Operate with a high degree of autonomy and professionalism; successfully prioritize workload in accordance with business goals 

Competencies:

* Ability to influence with or without direct reports, facilitate groups with diverse perspectives, bring teams to the best solutions. High tolerance for ambiguity, able to create order from chaos. 

* Takes accountability for actions, drives results, and learns from mistakes. Is direct and truthful and therefore widely trusted - delivers on promises, goals, and expectations. Makes quality decisions and resolves problems rapidly. Asks "what can I do to help?” 

*  Ability to communicate effectively up and down, at all levels of the organization, teach and present complex and/or new ideas with clarity and simplicity. 

* Excellent planning and prioritization skills with the ability to multitask and adapt. Able to synthesize large amount of information. Able to deliver results despite shifting environment.

* Ability to identify problems, define problem statement clearly and accurately and apply structured and disciplined methodology to identify data-driven root causes. Innovative and effective in solution development, risk mitigatio...

We seek a highly motivated Scientist / Sr. Scientist to lead biomarker development efforts in support of Genentech’s Oncology pipeline. The incumbent will lead a small laboratory group focusing on predictive and pharmacodynamic biomarker development efforts, as well as lead and support biomarker subteams for programs in clinical development. All of the Scientists in OBD are encouraged to develop a focus in one of several areas that advance our understanding of specific diseases or enable advanced biomarker assessments through exploration of innovative, cutting-edge technologies.  For this particular position, a strong background in cancer cell signaling and cancer genomics, evidenced by peer reviewed publications in top tier journals, is required.  Practical experience with predictive or pharmacodynamic biomarker development in an industry setting would be an important asset.  The successful candidate is expected to effectively lead cross functional teams, to publish innovative biomarker or disease focused research in high quality scientific, technical or medical journals, present to our key investigators and at meetings and promote collaborative efforts to push biomarker sciences forward. Scientists / Sr. Scientists in OBD are expected to be, or develop into, externally recognized leaders in clinical translational sciences.

As a Scientist / Sr. Scientist, you are expected to:

• Provide exceptional scientific leadership within OBD, as well as to other functions, subteams / teams at Genentech / Roche
• Develop and effectively manage a small laboratory group, predominantly focused on scientific support for molecule programs
• Drive scientific and technical innovation collaboratively with other members of the Department
• Lead one or more biomarker subteams
• Develop and execute on lead and exploratory biomarker strategies for one or more projects
• Participate in, or lead, disease focused translational biomarker programs, or develop a key focus on novel technologies that advance clinical biomarker assessment
• Publish in high quality scientific, technical or medical journals
• Represent OBD externally through presentations at key National / International meetings, interactions with our key investigators
• Participate and thrive in an interactive, team oriented culture

We seek a highly motivated Scientist / Sr. Scientist to lead biomarker development efforts in support of Genentech's Oncology pipeline. The incumbent will lead a small laboratory group focusing on predictive and/or pharmacodynamic biomarker development efforts, as well as lead and support biomarker subteams for programs in clinical development.

All of the Scientists in OBD are encouraged to develop a focus in one of several areas that advance our understanding of specific diseases or enable advanced biomarker assessments through exploration of innovative, cutting-edge technologies.

For this particular position, a strong background in cancer immunotherapy or the biology of the tumor microenvironment, evidenced by peer reviewed publications in top tier journals, would be an important asset. The successful candidate is expected to effectively lead cross functional teams, to publish innovative biomarker or disease focused research in high quality scientific, technical or medical journals, present to our key investigators and at meetings and promote collaborative efforts to push biomarker sciences forward. Scientists / Sr. Scientists in OBD are expected to be, or develop into, externally recognized leaders in clinical translational sciences.

As a Scientist / Sr. Scientist, you are expected to:

• Provide exceptional scientific leadership within OBD, as well as to other functions, subteams / teams at Genentech / Roche Develop and effectively manage a small laboratory group, predominantly focused on scientific support for molecule programs
• Drive scientific and technical innovation collaboratively with other members of the Department Lead one or more biomarker subteams
• Develop and execute on lead and exploratory biomarker strategies for one or more projects
• Participate in, or lead, disease focused translational biomarker programs, or develop a key focus on novel technologies that advance clinical biomarker assessment
• Publish in high quality scientific, technical or medical journals
• Represent OBD externally through presentations at key National / International meetings, interactions with our key investigators
• Participate and thrive in an interactive, team oriented culture

The Department of Safety Assessment at Genentech providesscientific leadership and plays an active role in the process of drugdevelopment from late-stage discovery through marketed products. We are seeking an Associate Scientist/Scientist in the Department of Safety Assessment to supportdrug discovery and development.   This role will involve working in acollaborative team environment as part of the comprehensive safety assessmentof Genentech therapeutics by providing discovery and investigative toxicologysupport to early stage small molecule research programs.  

Responsibilities

Proactive risk assessment ofpotential toxicity issues related to undesired or exaggerated pharmacology,investigation or characterization of potential toxicity issues to enable smallmolecule lead optimization and candidate nomination.

In this role, the toxicologist willprovide representation to discovery project teams, which will include safetytarget assessments, strategic planning and designing, implementing andsupervising  toxicology studies in support of compound lead optimization(e.g. in vitro toxicity screening, counter-assay development) and mechanisticinvestigations (development of hypothesis-driven research plans, in vitro or invivo model development and qualification, and scientific projectmanagement).  This position will include staff supervision as needed andcontributing to the continued refinement of lead optimization andinvestigational strategies and identification of new technologies.  Thediscovery toxicologist will interact closely with research scientists andSafety Assessment development toxicologists and pathologists to ensure thatdiscovery teams consider all of the appropriate strategic needs for candidateidentification with regard to toxicology issues, thus providing bettercandidate selection and characterization of toxicology issues at the time oftransition to early development.

Description Main Purpose of the Position:

• Direct Quality support staff and operations in accordance with cGMP regulations and Roche standards.
• Provide leadership and guidance to immediate staff hosting inspections or performing Quality Systems functions as assigned.
• Provide the Director, GQIM, with expertise in device and/or combination product inspection issues and risks.

Job Duties/Responsibilities:

• Optimize resources with the PTQS department.
• Interpret, execute and recommend improvements to Quality operational policies, plans and procedures.
• Provide input to department budget.
• Monitor and control expenditures against the department budget.
• Provide input for the development of overall Quality objectives and long-range goals.
• Notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
• Lead and participate in continuous improvement initiatives for Roche Quality Systems.
• Sign documents for activities as authorized and described by Genentech policies, procedures and job descriptions.
• Be accountable for behaviors described in Core, Common and Critical Competencies.
• Perform any other tasks as requested by Senior Management to support Quality oversight activities. Technical

Duties/Responsibilities:

• Develop and oversee implementation of the Inspection Risk and Readiness systems to ensure on-going inspection readiness.
• Collaborate with Pharma Technical Operations and Quality areas as needed to identify inspection risks and mitigation plans.
• Serve as a GQIM primary point of contact and liaison for assigned sites
• Manage and oversee the inspection readiness program across sites to ensure proper deployment and reporting of inspection risks
• Lead or support regulatory inspections as appropriate.
• Collaborate with sites to develop and communicate inspection strategy, approach and goals.
• Communicate potential inspection risks and current state of inspection readiness to Senior Management.
• Provide input into the design and presentation of inspection readiness performance metrics
• Act as an advisor to internal project teams by providing extensive knowledge of regulatory requirements, industry standards, and company strategy.
• Attend and participate in external regulatory and/or compliance organizations, and applicable industry conferences to exchange information regarding current regulatory inspections and to stay current on inspection trends.

Job Duties/Responsibilities:

• Perform microbiological, biochemical and analytical lot testing of raw materials, E. coli and mammalian cell banks, commercial and clinical fermentation, purification, and final product samples according to GMPs.
• Review data and assess against established acceptance criteria. 
• Evaluate data to identify trends and/or establish limits. 
• Identify gaps in and potential improvements to systems and procedures. 
• Perform equipment qualification and or maintenance. 
• Prepare and maintain standards, controls, stocks, and cultures per established procedures. 
• Assure and apply GMP throughout all operations. 
• Coordinate with customers to support multi-site operational activities. 
• Present analytical procedures and results during internal and external audits and regulatory inspections.
• Participate in and/or lead projects and process improvements. 
• Perform other duties as requested by managers to support Quality activities. 
• Works to meet schedules, timelines and deadlines. 
• Meets scheduled performance of 95% on time.

Technical Duties/Responsibilities

• Write technical protocols and reports under limited supervision. 
• Identify and propose resolutions for study or project deviations. 
• Provide input to and participate in assay transfer and assay validation.
• Perform technical review of data derived from complex tests. 
• With limited supervision, design and execute quality investigations and CAPA (corrective actions preventive actions) initiatives as needed. 
• Identify, troubleshoot, and propose resolution to technical problems. 
• Identify and propose resolution for discrepancies. 

The role of the Validation Engineer, located in San Francisco, 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 to  work with delivery units to advance existing emerging business critical technology according to Roche Pharma needs. 

The selected candidate will be responsible to:

Participate in the development of new standards and revision of existing standards related to Computer Systems Validation (CSV).  This includes, but not limited to policies, directives, and Global Informatics standard operating procedures related to the CSV area.

Assemble global feedback on proposed or existing standards and tools and providing recommendations for new guidance/standards or revisions to existing guidance/standards.  

Provide consultation and guidance to delivery and operational units within Pharma IT to provide accurate interpretation of Roche CSV approach and requirements, information concerning regulatory requirements related to CSV in the specified area, updates on changes in the regulatory environment

Assure that processes are established across Pharma IT to support delivery and operations of compliant systems.

Gather and analyze metrics and key performance indicators to identify opportunities for process improvement

Escalate non-compliance against quality standards to appropriate governance bodies and Risk Management function for resolution

Facilitate and leverage quality practitioners within the delivery units  to identify best practices,  and lead improvement initiatives across functional areas

Identify new training programs and/or revisions to existing training programs and approaches for delivery of training within and outside of Global Informatics

Provide change request control and support for legacy GMP systems 

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

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

Responsibilities:

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

Position Summary:

The Commercial Control System Lifecycle Management function of MMTech at Genentech has an open position for a QC Scientist/Senior QC Scientist to support lifecycle management of commercial biologics control systems.  This position is part of a function responsible for developing and implementing strategies to systematically evaluate and update control systems for the Genentech/Roche product portfolio.   

MMTech is part of the Genentech/Roche commercial quality organization and is responsible for method validation, control systems and specifications, reference standards, assay transfers, and providing scientific/technical support for the global QC Network across the commercial biotechnology product portfolio.

Job Description:

The individual will support the development, implementation, and maintenance of strategies to systematically assess and update commercial product control systems.  He/she will manage product, process, and external knowledge to ensure that control systems reflect current product and process understanding, analytical technologies, and Health Authority expectations.  The individual will be responsible for contributing to reports that document information supporting control system assessments and revisions.

As part of the control system evaluation and revision, this individual will:

• Oversee comprehensive control system assessments based on: identification of critical quality attributes, method and process capabilities, current industry practices, and contemporary Health Authority expectations
• Lead cross functional technical teams that perform detailed physicochemical characterization, method development/validation, and sample testing so that control system revisions are effectively managed and aligned with present-day requirements
• Provide scientific input and technical oversight to support control system changes
• Partner with subject matter experts to identify and complete key activities required for control system updates
• Collect and analyze results from product release and stability testing for use in evaluating and updating specification acceptance criteria
• Provide technical review and approval of analytical control system cGMP documents
• Support and coordinate quality assurance activities/reviews in Quality systems (e.g. Change Control, Discrepancy Management, etc.) to ensure compliance to procedures, current GMPs, and regulatory requirements
• Support regulatory submissions and inspections through authorship of relevant CMC sections, written responses to agency requests, and direct interactions with Health Authorities

Applicants should be comfortable working both independently and collaboratively as part of a team. The position offers opportunities for professional and scientific growth in a dynamic work environment.

E2/E3 position depending on experience of candidate.

Perform microbiological testing of raw materials, E. coli and mammalian cell banks, commercial and clinical fermentation, purification, and final product samples to meet standard lead times.  Review data and assess against established acceptance criteria.  Identify discrepancies, participate in quality investigations and CAPA initiatives as needed.  Participate in assay, facility, equipment and process validation. Perform equipment qualification and maintenance activities.  Support nonroutine microbiological projects and studies.  Prepare and maintain standards, controls and stock cultures per established protocols.  Support the maintenance and compliance of operational areas.  Assure strict adherence to cGMPs throughout operation.  Ensure training qualifications are up to date.  Identify and support resolution of technical problems.  Actively participate in group projects and process improvements.  Perform routine maintenance duties to ensure inspection ready state.  Draft protocols and reports under supervision.  Work with internal and external groups to develop methods for clinical products for in process and final products testing.

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.

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 Associate Program Directors provide regulatory leadership for one or more regional development projects. Regulatory Program Management Associate Program Directors are responsible for the development and implementation of regulatory strategies to facilitate the development and approval of Roche medicines for human use. Regulatory Program Management Associate Program Directors are expected to lead their assigned projects and represent PDR to cross-functional teams and groups with supervision. Regulatory Program Management Associate Program Directors are responsible for working cross-functionally and coordinating regulatory-related activities across PDR functions and with other internal partners. Regulatory Program Management Associate 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.

EXAMPLE DUTIES AND 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 and regional 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 projects at any one point in time

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 and/or regional 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 and/or regional 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 ...