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.

The successful candidate will be a key member of the Cross-Portfolio Analysis & Communications (CPAC) team within PPP/Pharma Portfolio Management. The CPAC team provides management with late stage and cross-portfolio information that enables a shared understanding of the portfolio, and robust analytics that offer unique insights on Roche’s direction, strategic alternatives, and ultimately contribute to effective corporate decision-making.

Responsibilities:

• Representative responsibilities associated with the role are detailed below:
• Develop analytics around portfolio spend, future portfolio projections and “what if” scenarios
• Assess Roche’s performance versus competitors across various R&D-related metrics
• Provide guidance to, and participate in, cross-functional initiatives on R&D productivity, cost and valuation metrics, and long-range planning
• Participate in preparation of quarterly reports for senior management on progress of portfolio and implications

Job Skills and Expectations

• A strong understanding of pharmaceutical/biotech industry, drug development trends, and business strategy
• Financial acumen and understanding of commercial and development forecasting methodologies
• The ability to analyze and draw conclusions out of large, complex data sets and articulate the key findings to management and functional leaders
• Strong oral and written communication skills
• Innovative mindset and comfort with ambiguity
• The ability to build cross-functional partnerships and engage in (and at time lead) cross-functional initiatives
• A desire to make a difference and commitment and drive to see things through

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

The Senior Corporate or Corporate Counsel will work as part of the Healthcare Law Group within Genentech's Legal department. 

The position will initially focus on counseling Genentech’s commercial sales and marketing clients, with opportunities to advise medical affairs and development across the lifecycle of products. The position may require counseling medical affairs and development teams with human medicines and companion diagnostics in all phases of development.  

 JOB/POSITION SCOPE:  

•  Manage outside counsel on complex or more advanced matters or projects 
•   Responsible for one or more key client relationships typically at Director level or   higher 
•  May be single point of contact or represent practice group or functional area on significant projects or committees 
• Provide advice, education, training and legal direction on FDA labeling and promotional matters, healthcare fraud and abuse laws, product liability, antitrust, privacy and other laws impacting the commercialization of biotech products;
•  Assist in structuring tactics and related contracts in compliance with applicable law;   
•  Serve as lead legal counsel for global development programs and medical affairs initiatives
• Negotiate agreements with cooperative groups, government entities, study sites, and other parties involved in global studies; and
• Draft and interpret  company policies, and educating clients and colleagues about enforcement trends and discrete legal issues.   
• Act as a subject matter expert on all matters relating to healthcare law and related business operations 
•  Act as a standing or ad hoc member of business or leadership teams and provides legal counsel and expertise into business decisions 
•  Develop an in-depth understanding of assigned departments and functions in terms of their, organizational structure, processes, business goals, strategies and challenges, etc. 
•  Provide  legal advice in matters relating to healthcare law, including healthcare fraud and abuse, FDA regulations on clinical trial conduct, labeling, advertising and pharmacovigilance, product liability, pricing and reimbursement, antitrust, privacy, and other matters relevant to the development, manufacture and commercialization of products 
• Provide  input and legal advice on business strategy, tactical plan development and implementation, and other business issues; including legal assessments, solutions-oriented risk mitigation strategies, messaging, and interactions with healthcare professionals, patients and other external parties 
•  Participate  in, lead  and/or present  to various Company committees or other advisory, project or work teams and provides healthcare and business law expertise and guidance 
•  Review  business materials (clinical trials, brand plans, promotions, medical plans, publications, training documents, etc.) requiring legal input and advises internal clients, partners and stakeholders on compliant strategies, plans and tactics 
•  Provide  transactional support to assigned internal clients. May include drafting, negotiating, and/or reviewing contracts, creating, updating and training on contract templates, negotiating language, developing associated legal/contractual documentation and/or policies & procedures, and counseling on contract disputes   
•  Interact and communicate with Roche affiliates and global partners, as appropriate, to apprise them of relevant Company policies, procedures, practices, important business issues, etc. and share best practices or coordinate legal support 

 PEOPLE MANAGEMENT: 

• May manage administrative personnel 
• Where applicable, lead recruitment, hiring and on-boarding for direct report positions 
• Accountable for direct reports' work to ensure on-time, on-target and within-budget results 
• Ensure direct report(s) are appropriately trained, developed and coached 
• Responsible for performance management of direct report(s)

DEVELOP & MAINTAIN  KNOWLEDGE 

• Stay abreast of evolving healthcare and related legislation and regulations and the enforcement landscape. Advises the Company and colleagues of potential implications to current or future strategies and operations and assures ongoing compliance 
• Develop and implements training to educate internal clients, partners and stakeholders on key policies, procedures, practices and requirements for healthcare and related legal c...

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

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

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

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

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

Major Responsibilities include:

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

This South San Francisco, CA-based position has the responsibility for operations support of all Pharma and Diagnostics Contact Center infrastructure in the North America (NA) region.  This includes 39 contact center groups across two (2) main campuses and six (6) additional sites, handling over 5 million calls in addition to a large number of fax, email and other interactions per year.  This individual is a thought leader and strategist and will have a deep understanding of contact center technologies and processes.  He/She will work on unusually complex technical problems and provide solutions, which are highly innovative and ingenious. This individual will serve as technical lead on large-scale enterprise project teams, that will transform how our contact centers are currently doing business. He/She will work with IT Architecture to evaluate and analyze emerging technology associated with delivery of voice calls and other interaction channels and corresponding data as well as influence the development of contact center roadmaps and strategies in order to meet the business needs within the NA Region. It is critical that this person understand the individual needs of each line of business within the NA Diagnostics and Pharma contact center business units.  This position requires a solutions-oriented individual who can be dedicated to serving the business by leveraging technical expertise, strategic planning, clear business understanding and excellent communication and collaboration skills to deliver first-class voice and contact center infrastructure and support.

This position will help consolidate the current disparate NA Contact Center solutions into a single regional, centrally supported platform that will meet the current and future needs of the business.

You will have the following key responsibilities:

• Operate as the SME and process owner for Contact Center Solutions in NA
• Key contributor in strategic planning and development of annual goals, budget and objectives for NA Voice Services
• Key contributor to TAF Roadmap and technology for NA Enterprise Voice and Contact Center systems and related solutions
• Collaborate with architecture and engineering on technical aspects of Telephony and Contact Center infrastructure and solutions
• Work with the Global Head of Voice Services and appropriate team members to define, develop and implement Global, Regional, and local standards and SOPs 
• Provide leadership and visibility for Voice Services NA Region within the Global IT Architecture, Engineering & Operations organization 
• Provide deep technical expertise over a broad set of current technologies and mentoring of other team members in these areas
• Create collaborative partnerships across IT and the business
• Ensure regular on-going communication is happening in all areas of responsibility with critical stakeholders to create awareness and set expectations 
• Act as an advocate and serve as a trusted advisor to the business
• Work with Commercial Marketing on FDA Drug approvals and launches and new programs and special toll free number assignment 
• Work closely with the business to understand portfolio and prioritization of business requirements
• Develop and maintain clear project process and engagement models and communicate through proper channels to ensure alignment with the business for successful implementation and delivery of contact center projects
• In an operational setting, oversee the deployment of software enhancements, troubleshoot production systems, ensure root cause analyses (RCA) is performed for all outages and adheres to established SLAs all while providing excellent customer service
• Provide leadership, vision and mentoring to the Voice Services and Telecom vendor on-site staff
• Monitor legal and regulatory compliance of all voice systems, including adherence to HIPPA and California State standards for voice systems 
• Participate in leadership activities to promote the achievement of all goals and objectives
• Look for new opportunities for infrastructure consolidation and centralized management

The Global Engineering team is responsible for making technology happen for Genentech and Roche global by transforming the “technology roadmaps” into live solutions. The Global Engineering team is present in 4 locations: Basel, Madrid, Shanghai and South San Francisco, covering all time zones with around 100 highly qualified engineers. The Senior Engineer Security & IAM, NALA Region position is located at the South San Francisco site. The main responsibilities of the position are:

• Design and develop technology solutions, including evaluation of promising technologies and development of evaluation criteria
• Work with vendors, architecture, operations and solution owners managing the Proof of Concept and testing scenarios
• Lead multi-threaded, globally distributed and complex projects
• Mentor less experienced team members on industry standard design practices
• Perform configuration, integration, functional specifications and development tasks for technology solution and services, including first implementation of the designed solutions
• Develop best practices for technology solution for reuse across the compute environment
• Ensure efforts and solutions align and adhere to the organization’s Technical Architecture Framework (TAF) policies, standards and direction as well as Solution Owner requirements
• Ensure proper training of support teams on the technology solution
• Stay abreast of operational difficulties and issues; work with support team staff to provide escalation support. 
• Document and optimize technology solution environment as required
• Ensure Quality standards as per company specifications are followed
• Occasional travel and working outside standard office hours including weekends and holidays

Project Manager – IT (Genentech – South San Francisco)

The MCCO Solutions team in IT Americas is looking for a motivated Project Manager to lead the delivery of technology projects in support of US Commercial Operations. The IT Project Manager is accountable for the successful delivery of technical solutions through effective planning and execution throughout all phases of the project management methodology. The PM will be responsible for managing assigned resources, effectively tracking budgets and financial forecasts, creating and tracking detailed project plans, leading and facilitating project meetings as well as proactively controlling project scope, risks and issues. This PM position will be accountable for projects in the MCCO Solutions group for the Commercial Customer Operations portfolio.

Duties:

* Define, plan, and lead the execution of technical implementation projects, while balancing the competing demands of scope, time, cost, quality, resources, and risk

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

* Manage relationships with various technology vendors/partners and business stakeholders to achieve project objectives

* Establish and maintain 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

* Suggest process improvements where appropriate to improve operational efficiencies

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

* Other duties as assigned

• Develop medical strategies based on strong scientific rationale for pre-launch and marketed products in Endocrinology, with a focus on growth disorders

• Establish standards for all Medical Affairs activities, including Sponsored Trials, Supported Trials, Registries and Exploratory Data Analysis of internal and external data bases, publications, medical education, medical communication, Advisory Boards and promotional review.  

• Participate on Franchise Leadership Teams contributing the medical perspective to franchise business strategies and evaluation of new product/development ideas. 

• Work in a cross-functional/matrixed environment, interfacing with Development and Global Medical Affairs personnel to provide the US Medical input into Development programs and Global Medical Affairs strategies

• Responsibility for the medical affairs budgets for the Growth Disorders Franchise to ensure adequate resources and their effective allocation. 

• Interact and manage relations on behalf of Genentech with Key National and Regional Thought Leaders in Endocrinology. 

• M.D. with board certification/eligibility in Endocrinology

Technical/Functional Competencies 

• Relevant therapeutic area experience in Endocrinology (5 or more years, inclusive of academic experience)

• Relevant biotech/pharmaceutical industry experience (2 or more years) strongly preferred

• Considerable experience in the principles and techniques of data analysis, interpretation, and clinical relevance

• Comprehensive understanding of product and safety profiles

Core Competencies / Other Key Behaviors

• Participate on cross-functional teams for evaluation of new products/ development ideas and implementation of franchise business strategies.

• Scientific leadership 

• Leading Teams

• Collaboration and Teamwork 

• Excellent Judgment and Analytic skills 

• Drive for Results

• Effective Communication 

• Integrity

• People Development 

The Business Solution Manager (BSM) position is part of a global team that supports Product Development Biometrics & Clinical Operations. This role includes working on major cross-functional system initiatives, providing user support, system upgrades/enhancements, and business case development as well as integrating business processes and technology. 

In this role the BSM proactively assesses upcoming changes in Statistical Analysis tools and internal business environments, in compliance with the IT standards/processes and identifies solutions in support of the following areas:

• Epidemiology and Patient Reported Outcomes (EpiPRO)
• Clinical and Non-Clinical Biostatistics (PD, gRED and pRED)
• Thesaurus Management and Coding 

The BSM will also support cross functional initiatives led by other business areas and provide process expertise to support the development of solutions that align with the Product Development Information Landscape & Biometrics Information Landscape roadmaps.

In partnership with Biometrics & Clinical Operations, Project Management and Delivery Services, the BSM responsibilities include but are not limited to:

• Development of Roche's Informatics Biometrics & Clinical Operations IT project portfolio in partnership with the customer, project manager and solution architect. 
• Drive harmonization of processes and practices across sites and departments through common standardized data models, applications and technologies that are in line with Roche's strategies and architectures. 
• Providing efficient and effective business processes and practices expertise in a global regulated environment 
• Development of strategies to enable existing Informatics systems to address changing Roche policies and directives. 
• Knowledge of analytical software like SAS and R, especially related to analysis of ‘Real World Data’
• Participating in Roche BSM Forum and collaborate with other BSM's  
• Actively participating in industry groups to understand the future of ‘Real World Data’ and strategy to incorporate in Roche's strategies and solutions.

Purpose:

The senior utilities engineer provides technical leadership and accountability for plant and GMP utilities engineering in the delivery of capital projects and engineering services for research and development (R&D) and quality laboratory, as well as commercial and clinical manufacturing related facilities.

Responsibilities:

• The senior utilities engineer will work effectively on multi-discipline engineering capital project teams, as well as other project related cross-functional teams with representatives from departments throughout the Pharmaceutical Technical Operations and R&D organizations.

• Responsibilities may extend to all regional Americas manufacturing and research facilities, as well as the network of Contract Manufacturing Organizations organized under the Manufacturing Collaborations group.

• The primary area of focus for this position will be the execution of projects from design through commissioning and qualification. The senior utilities engineer will be accountable for:

- Planning and Execution of Projects: including project approach and resource needs, options analysis, utility systems and equipment design, engineering document development, and system ownership through the project delivery phases of plan, design, procure, construct, commission and qualification for research, cGMP and development facilities; and 

- Technical Analysis:  including utility system and technology plant fits, capacity and equipment utilization, value engineering, sustainable design, constructability and assessment of applicable new technologies to balance performance, cost and maintainability.

• Areas of expertise include systems and equipment for purified water, water for injection (WFI), clean steam, process air, process gases and process waste, as well as associated knowledge in plant steam, plant chillers and utility piping.

• This position requires coordination of Genentech/ Roche and/or contract engineering resources.  Facilitating meetings, directing engineering firms and consultants, field supervision, equipment inspection and start-up, construction trade coordination, and training of operational staff are often required.  Success in these areas will depend upon the individual’s ability to effectively communicate, collaborate, and foster positive interactions with team members, while diligently managing adherence to project scope, budget and schedule.

• The senior engineer is expected to be an effective communicator of ideas, project goals and results.  With minimal supervision, is expected to make presentations and updates to senior management and in broader forums both internal and external to Genentech. 

• The senior engineer is expected to contribute to increasing the efficiency and effectiveness of the Engineering Technology department by contributing toward infrastructure improvements to guidelines, procedures, practices, standards and cross-functional business processes.  The senior engineer should share insights and improvements, participate in design reviews across the portfolio of departmental projects, and contribute to best practice forums across our network of global engineers and partners. 

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

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.

The primary responsibility of this position will be to focus upon clinical product planning for multiple molecules; which includes partnering with Clinical Operations to translate trial assumptions into drug forecasts, utilizing SAP/APO to develop supply plans and to align these supply plans with the Technical Development Team, and partnering with Master Production Planners (MPP) to ensure plans are converted into bulk, filling, packaging, and contract manufacturing schedules which meet customer requirements.  For Finished Goods, the CDSL is also accountable for generating a distribution plan to handover to the Global Clinical Distribution team and working with this group to ensure a seamless supply chain throughout our distribution network.  The CDSL will be knowledgeable of the costs and capacities associated with our manufacturing network, and will assist the MPP in developing recommendations to balance production requirements, customer service, and manufacturing capacity.  The CDSL will assist in the execution of our Clinical Demand & Operations Planning process, in capturing supply planning metrics and in developing/implementing strategies to drive improvement in those metrics; enabling the development of robust business processes and our ability to reach our department goals.

Responsibilities:
¿ Partner with Clinical Operations teams to develop drug forecasts based upon clinical trial assumptions, design, and timelines
¿ Leverage the Generic Forecast Assumption process to apply drug forecasts to future planned trials listed in Plansource
¿ Collaborate with Development Partners to understand partner demand and timelines for trials not being run by Genentech
¿ Initiate product definition forms to enable creation of new planning and execution items in SAP
¿ Utilize clinical forecast tools to consolidate all demand for Roche/Genentech, or CMO produced drugs as well as required Other Study Drug procurement
¿ Utilize SAP to create/communicate a Master Production Plan, a depot Distribution Plan and OSD procurement plan that meets global clinical demand, inventory targets, project budgets, and manufacturing capabilities
¿ Actively participate on TDT teams to ensure alignment of demand and supply plans with TDT development strategy and budget, and capture all project driven demand in SAP
¿ Lead cross-functional Global Supply Execution Teams to drive alignment of activities enabling drug to be packaged, released, and ready to ship; meeting trial First Site Activation goals
¿ Manage inventory and production orders for assigned products; monitoring inventory levels, firming production orders, controlling lot allocations, managing expiration dating
¿ Perform required Supply Planning activities & processes driving cross functional action to ensure all drug supply plans are achieved
¿ Participate in the S&OP process as necessary, leading cross-functional process improvement RCAs

Description - 

An opportunity for a protein biochemist is available to join a chemical biology group in the Department of Early Discovery Biochemistry. The group uses a multidisciplinary molecular approach for target validation. Recent efforts focus on the use of peptide phage display and small molecule tools for modulating protein-protein interactions and fluorescence imaging of cellular proteins. The successful candidate will be responsible for producing proteins and peptides of therapeutic interest and their characterization by analytical methods (affinity purification, RP-HPLC, SDS-PAGE and western analysis). He/she will also investigate the functional mechanism of bioactive ligands by biochemical and cellular assays. This is a basic research position that requires critical thinking, flexibility, multitasking and the ability to learn new techniques.

Responsibilities:

Works with senior biostatistics staff and clinical monitors on clinical development plans, the design and conduct of clinical studies and in the evaluation, interpretation and preparation of study results. As part of a clinical assessment team, collaborates in the preparation and review of clinical assessments. For assigned clinical development project(s), provides statistically sound experimental design and data analysis input to meet project objectives and Health Authority's statistical requirements. Reviews all project protocols, author protocol statistical analysis sections and generate study randomizations. Develops study analysis plans as a team member; lead this effort for selected studies. Reviews case report forms to ensure that protocol objectives are met and project standards are maintained. Develops statistical programs as necessary to perform analyses, and verify data accuracy and validity. Co-author efficacy analysis results in the clinical study report. Supplies statistical input for filing submissions and in response to FDA questions. Provides support for publications. Keeps abreast of new developments in statistics, drug development, and regulatory guidance through literature review, workshop attendance, etc.

The MCCO Solutions team in Genentech’s IT Americas organization is looking for a motivated Sr. Software Quality Analyst to lead all aspects of Quality Assurance and QA Testing of technology projects in support of US Commercial Operations.  The Sr. SQA will be responsible for managing the work of assigned Quality Assurance (QA) resources, effectively building and tracking QA Plans and Strategies, and ensuring end-to-end quality in all phases of the project lifecycle.  

Duties:

• Plan and execute functional, performance and stress testing on applications and systems using automation and manual testing
• Maintain an understanding of leading tools and technologies for development of mission critical web, database and related applications. (Mercury Suite, Selenium, Segue, etc)
• Lead the development of SQA Test Plans, Test Procedures, SQA lab standards and tool requirements
• Identify opportunities for process improvements that streamline development activities while minimizing risk
• Mentor other team members in testing processes & testing tools in order to execute Test Plans as required
• Manage work of onsite and offshore SQA testers as required 

We are seeking a Sr. Project Manager who will manage complex projects to successful and timely decision points from Late Stage Research through Proof of Concept. The Sr. Project Manager will actively contribute to the definition of project strategy and guide the project core and sub teams to deliver on project objectives. This position will be accountable for steering drug development teams through corporate processes. Additional responsibilities include but are not limited to the following:

• Establish and maintain functionally integrated project schedules to enable accurate project, financial and portfolio analyses and ensure accurate inputs are provided into business planning processes; Ensures alignment with project sub-teams and functional partners
• Oversees and prepares project team budget including resources and costs collaborating with Finance and other cross-functional department
• Communicate, document, and archive project team activities and decisions; act as a primary contact for project team related information
• Facilitate project team meetings, cross-functional communication and decision making, ensuring alignment with internal and external stakeholders
• Identifies, recommends and implements opportunities for streamlining or other efficiency/improvements for teams and business processes.
• Responsible for ensuring the team achieves and maintains a high-level of sustainable performance, by implementing appropriate team management best practices.