Provide statistical and strategic support related to clinical development plans, study designs, planning and execution of exploratory biomarker analysis, and incorporation of biomarker objectives in clinical development plans.

Major Responsibilities and Accountabilities:

• As part of a clinical development team, collaborates in the preparation and review of protocol writing, CRF design and monitoring of ongoing clinical trials.
• Provides technical and strategic support into clinical development plans
• For assigned clinical development project(s), provides statistically sound clinical trials design, including clinical pharmacology trials and data analysis input to meet project objectives.
• Supports teams in the development and review of regulatory submissions such as clinical protocols, INDs and pre-meeting packages.
• Provides strategic and analytical support for exploratory project activities such as biomarkers and PK/PD analysis
• Develops statistical analysis plans, including biomarker analysis plans, prepares data displays and as necessary develops statistical programs to perform exploratory analyses.
• Authors the clinical study report; with help from senior statistical staff, leads team members to complete the report.
• Provides advice and training on the use of statistical methods and software packages to the biomarker scientists
• Collaborates with scientists in support of external publications.
• Keeps abreast of new developments in statistics, drug development, and regulatory guidance through literature review, workshop attendance, etc.

The Quality Product Leader is part of Clinical (IMP) QA.  This position will be responsible for managing the quality logistics for commercial product used in clinical trials across the network. The job responsibilities include creating and implementing business processes to effectively manage the logistics for small and large molecule active, placebo, and comparators; both product produced by Roche and by a competitor.  The position is global.  This position will establish and maintain strong partnerships with internal and external colleagues, customers, and stake-holders.  These groups are located globally and are comprised of, but not limited to, QA Operations, Commercial Product Quality Stewards, External and Site Quality, Commercial QC, Product Development, Global Supply Chain, Country Qualified Persons and Pharma Technical Regulatory (PTR).

Accountable for end-to-end infrastructure and ensure thecomplete integration of the solutions into the operational landscape. SupportSolution owner with lifecycle management and Components.

This includes installation and upgrade throughmaintenance and operations to decommissioning.

1.2 PrimaryResponsibilities

• Provides technical Subject Matter Expertise input into solution design, optimization, change requests and problem resolution
• Participates in implementation of new projects and in changes of existing solutions and actively execute project related tasks and activities.
• Coordinates and manage installations, upgrades, changes and software integration including test design, execution and support
• Ensures the integrity of solutions and qualified state during their lifetime
• Coordinates and supports security patching and upgrades with the Solution Owners
• Ensures compliance with security SOPs/policies, and that adequate access rights are given to trained staff.
• Coordinates incident management activities with Solution Owners and the AE&O component Managers until final resolution and supervise re-active problem management process

• Identifies and analyzes potential areas for improvement of the solution (pro-active problem management), and Delivers continuous improvement of the solutions assigned.

• Represents the Delivery Organization into AE&O so that the business is represented in technology decisions, planning and participation.
• Ensures solution design and integration of the AE&O skill sets required to support the new solution
• Ensures re-use of existing AE&O solutions and components wherever possible to minimize the development of new solutions
• Ensures all new solutions are designed and developed in a cost efficient manner, delivering the appropriate level of service quality

• Ensures communication of AE&O initiatives, policies and important activities to appropriate Delivery Organization.

All candidates are encouraged to apply, however a preferred candidate has been identified.

The ideal candidate must have demonstrated the ability to handle confidential, complex and sensitive information, and the ability to establish administrative processes and procedures to assist the group with projects and tasks.  Candidate will provide accurate and effective administrative support for Managers within the group and coordinate administrative duties with other Administrative Professionals to provide seamless support for the group.

*Manage multiple schedules with heavy calendaring of complete meetings.  Arrange, coordinate and support meetings, events and activities both on and off-site.

*Identify and anticipate needs of the group and plan work activities accordingly.  Look for areas of activity overlap with co-workers and leverage resources to maximize time, resources and dissemination of information.

*Generate, disseminate and maintain documents and information.  Develop, implement and evaluate department work processes and procedures.  Manage deadlines related to business planning as well as special projects.

*Collaborate with Admin team to support complex projects and deadlines.

*Understand and troubleshoot from a broader perspective and anticipate the impact of office admin problems and solutions on the other areas.

* Understanding and experience with approval processes for vendor contracts, ideally within GNE, is highly desirable. A large fraction of the workload for this position will be administering contracts for HEOR research partners.

General office responsibilities include but not limited to:

 *Schedule and coordinate staff onsite/offsite meetings, assist with special projects, schedule travel for staff, process payment and expense reports, plan, schedule and coordinate WebEx’s and teleconferences, maintain files, order department office supplies, order catering and other supplies for a variety of meetings and events, fully utilize MAC and software applications.  Exercise independent judgment and discretion of sensitive/confidential information.

Main Purpose of the Position

* Manage the lifecycle of contract manufacturing activities for commercial products at one or more bulk drug substance (DS) third-party contract manufacturing organizations (CMOs), including CMO selection, process technology transfer, routine cGMP manufacturing, and site decommissioning upon completion of the contract.  

* Establish and maintain alignment between CMO site business, operational and quality objectives and plans and Roche’s commercial and manufacturing strategies and plans.

* Establish and manage business, operations, and quality relationships and communications between Roche and the CMO as the Roche’s single point of contact for the contract manufacturing relationship at the Joint Management Committee and Joint Steering Committee levels.

* Build and lead cross-functional teams of technical, quality, regulatory, manufacturing, engineering, supply chain and other subject matter experts to achieve CMO site business, operational and quality objectives, plans, and performance goals.

* Provide the single point of accountability for identifying and managing timely resolution of business, operational, and quality issues through the established CMO site governance structure.

* Manage the performance and development of direct reports as required to achieve organizational and department goals and a productive work environment.

Job Duties/Responsibilities 

Contract Manufacturing Lifecycle Management

1.   Selection.   Build and lead the Roche cross-functional team charged with for identifying, evaluating, and selecting and negotiating a contract with a CMO for bulk contract manufacturing, specifically:

* Develop CMO selection plan, define contracting manufacturing requirements and evaluation criteria, and identify and screen CMO candidates.

* Develop Request for Proposals (RFPs), and solicit and evaluate contract manufacturing proposals.

* Lead due diligence visits, analyze and evaluate CMO proposals, and develop recommendation(s) for CMO selection.  Drive decision-making for CMO recommendation through appropriate governance committees.

* Lead contract negotiations for technology transfer and manufacturing and supply agreements.

2. Implementation.  Build and lead the cross-functional team charged with transferring, qualifying, and achieving regulatory licensure the process and analytical technologies (“technology transfers” for manufacturing Roche’s DS products at a CMO’s manufacturing facility, specifically:

* Lead the Technology Transfer project for Roche through regulatory licensure of the CMO’s facility for routine cGMP manufacturing, including serving as the Leader of the Joint Management Team.

* Plan and manage the transfer of Roche’s DS manufacturing process(es), analytical testing technologies, and supply chain processes to achieve product and process comparability between the donor and receiving sites.

* Manage the project governance structure, including identifying and managing issue resolution and milestone stage gate reviews.   

* Oversee and manage contractual commitments, obligations, and processes, including milestone dates, financial terms, dispute resolution, and materials and equipment.

3.   Site Management.  Build and lead the cross-functional team charged with managing contract manufacturing at CMO following regulatory licensure, specifically:

1.1. Business

* Serve as Roche’s Site Manager, actively managing the on-going relationship with CMO to ensure Roche’s expectations for product quality, cGMP compliance, costs, and production targets are clearly understood, well-documented and consistently met.

* Lead project team meetings and technical operations meetings.

* Coordinate and manage visits and contact between Roche personnel and the CMO.

* Establish and maintain a Joint Service Agreement with the CMO that defines roles and responsibilities, business processes, systems and tools, supply chain assumptions and standards, and performance metrics to foster an effective and efficient business relationship. 

* Manage and monitor contractual commitments, obligations, and processes, including milestone dates, financial terms, schedules, materials, and equipment.

1.2. Operations

* Serve as site Technical Lead, coordinating technical review of process data and proposed facility, equipment, system, or process changes with Roche Subject Matter Experts (SME's).

* Facilitate issue resolution and problem solving within CMO site, with Roche functional departments supporting Contract Manufacturing, and through the agreed project governance structure as appropriate.

* Coordinate cross-enterprise forecasting, capacity planning, scheduling, and inventory management processes for critical ...

The DMPK group is dedicated to enabling the discovery, developmentand commercialization of safe and effective medicines by elucidating theabsorption, distribution, metabolism, excretion and pharmacokinetic propertiesof small molecule drug candidates. We accomplish this through the applicationof state of the art technologies and sciences of bioanalysis, drug metabolism,drug transport and pharmacokinetics. The DMPK group works in close partnershipwith disciplines such as medicinal chemistry, pharmacology, toxicology,pharmaceutical sciences, clinical pharmacology and regulatory to optimizeleads, select clinical candidates, conduct preclinical development studies,support clinical evaluation and contribute to IND and NDA filings.

We are seeking a candidate to support both in vitro and in silicoADME.  The candidate will work with anestablished team on various in vitro assays and will collaborate with otherscientists in the group to perform hypothesis-driven studies to address ADMEquestions.  On the in silico side, thecandidate will apply ADME models to support projects and maximize the value of existingADME data. They will work at the intersection of modeling ideas, modelgeneration and experimental investigation to support/build SAR and meet projectneed.  A key part of the role will becontinuing education in the department on use of predictive DMPK and championinguse of in silico tools. The candidate will be a highly effective and energizingcollaborator and will work scientists from multiple disciplines including computationaland medicinal chemistry, safety assessment and pharmaceutical sciences.

The Vice President and General Manager for our Vacaville site is responsible for ensuring the safe, efficient, cost-effective, compliant and quality manufacturing of Roche/Genentech commercial drug substance. The individual will oversee all site activities. The VP/GM is responsible for leading and overseeing the assigned plant's operations, management and staff, with direct and indirect reports of over 700+ employees, annual expense and capital budget management of $200+ million USD, with total annual product manufacturing responsibilities in the multi-billion potential product sales. The VP/GM is responsible for all plant operations: including staffing of the plant, manufacturing, engineering, validation, facilities, technology, warehousing, Environmental Health & Safety (EHS) and operational excellence. VP/GM is accountable for meeting the site’s production plans, on-time, on-target and within-budget, and in accordance with all safety, quality, compliance, regulatory, productivity and other performance metrics and targets. The Vice President is a member of the Biochemical Manufacturing Leadership Team; and as such, plays a key role in defining, setting and implementing the long range vision, strategy, objectives of the overall network.

The Vice President will collaborate with peer VP General Managers to create a supply network that:

-- Ensures nimble decision making

-- Enhances operational practice sharing and process governance

-- Facilitates bulk network optimization and workforce planning

-- Facilitates bulk capacity utilization and cost of clinical manufacturing

-- Creates a clear charter and performance measures

Responsibilities:

• Stays abreast of internal and external industry and marketplace dynamics and evolutions

• Acts as a standing member of the Biochemical Manufacturing Leadership Team

• Identifies industry or other marketplace trends and dynamics that potentially impact Roche and its production operations

• Makes important contributions to the annual, medium- and longer-range vision, strategy, objectives and plans for the Biologics network. Includes important contributions to PT's biochemical manufacturing network: network optimization, sharing best practices, lessons learned, leveraging innovations and resources, etc.

• Evaluates new products, new or updated production processes, systems, technologies, equipment or other business and operational strategies and plans for potential implications to Roche/Genentech's manufacturing plants and operations

• As part of the Biochemical Manufacturing Leadership Team, makes important contributions to the site 5-year plans and annual revisions/updates

• Plays a leadership role in PT's talent management review and planning processes

• Champions initiatives, best practices, continuous process improvement, compliance, quality and the like

• Acts as a lead business process owner for biochemical manufacturing core and sub-processes

• Job Family & Role-specific Responsibilities:  

• Drives and delivers business results across the assigned plant; focusing on manufacturing processes that improve reliability, increase simplicity, lower cost, and enable sustainable and scalable growth

• Works closely with partners in Quality & Compliance, Regulatory CMC & Information Systems, Global Supply Chain, and Corporate EHS to develop appropriate safety, compliance, quality, cost, productivity and other relevant policies, procedures, goals and metrics

• Accountable for ensuring the assigned plant consistently meets all cGMP (Current Good Manufacturing Practices) and other regulatory requirements

• Accountable to ensure, at all times, that the assigned plant is regulatory inspection-ready

• Defines, sets and oversees effective and efficient execution against the annual, medium- and long-range vision, strategy, objectives and plans for the assigned plant, its operations, projects, management and staff

• Works closely with Corporate Engineering to plan for and execute plant capital projects

• Responsible for ongoing development and improvement of the infrastructure necessary for the assigned plant to effectively and efficiently deliver against its vision, strategy, plans a...

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

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

Primary Accountabilities

Engagement:

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

Service and Project Delivery:

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

Alignment:

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

Management:

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