Responsibilities      

• Perform technical and compliance review of analytical testing results for bulk, final product, pre-clinical, cell banking and stability products
• Compile analytical data for bulk, final product, pre-clinical, cell banking and stability products
• Set up stability studies for clinical products in accordance internal PQS and ICH stability guidelines. 
• Plan and prioritize new stability studies to ensure regulatory submission timelines are met.
• Review and approve time point data to ensure regulatory compliance.
• Manage inventory of all stability studies, including sample submission to partner labs and cycle counting
• Assess and approve discrepancies of clinical and pre-clinical products
• Technical proficiency in analytical methodology and adherence to cGMP compliance
• Train colleagues on stability, assay review and analytical methodology as appropriate
• Identify and address gaps in systems and procedures for continuous improvements.
• Accomplish corporate, operational and departmental goals
• Exert influence in the development of objectives and long range goals of the organization
• Make independent decisions around complex issues in alignment with Roche policies
• Support internal and external audits
• Work with internal departments and outside vendors, collaborators and partners concerning projects and commitments
• Mentor and supervise (as required) other staff members on QC related, processes and projects.

Position is responsible for the development, maintenance and advancement of the Enterprise Resource Planning (ERP) system recipes and master data used by SSF Clinical Supplies Management.  Successful candidates will represent the department as a subject matter expert and liaison between a variety of key internal and external stakeholders.  They will lead processes to ensure successful SAP data development, deployment, and maintenance and will ensure appropriate integration of CLARA, R3, and APO with supporting systems.  The successful candidate will be adept at leading cross-functional teams in problem identification and resolution.  They will be relied upon to work collaboratively and independently to solve emerging challenges inherent to rolling out new data applications.  The position will provide support of user needs for current and future applications for the Clinical Supplies Management department.  They will represent the department in interactions with the global business process management community and will proactively identify areas for improvement.  Additionally, the successful candidate will play an important collaborative role in the integration of the newly formed production services team.  To this end, the successful candidate must also demonstrate competency and/or aptitude as well as interest in broader aspects of materials management, master production scheduling, capacity management, and detailed scheduling.  In addition to their system expertise, they will bring a willingness to learn new skills and tasks that will allow them to successfully backfill other production services roles in a dynamic environment.

Job Responsibilities

Scope of Work - The Business Analysts will be responsible for creating the SAP Recipe in collaboration with data owners to enable materials and capacity requirements planning and successful execution. Responsibilities of this position include:

*Develop SAP recipes for load into system
*Coordinate and lead data strategy and execution meetings with site and network representatives
*Provide technical solutions to a variety of problems of moderate scope and complexity.
*Develop solutions that are imaginative, thorough, practicable, and consistent with organization’s objectives
*Adhere to change management processes to ensure data accuracy is maintained across systems
*Provide reporting and analysis required to manage key performance indicators
*Translate business requirements to technical specifications and collaborate with key stakeholders to complete requests
*Provide training on usage, enhancements and changes to business systems
*Work is performed under limited direction and guidance, with general instructions on new assignments
*Proactively recommend priorities, timelines, and resources for addressing emergent business needs
*Participate in developing courses of action that may impact multiple functions in the organization
*Network with senior internal and external personnel in own area of expertise. Represent organization on assigned projects
*Identify opportunities for improvement
*Lead cross functional and cross network teams in the identification and implementation of improvement initiatives

Provide accurate and effective administrative support Managers within the group, and coordinate administrative duties with other Administrative Associates to provide seamless support for the group. 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. Manage multiple schedules with heavy calendaring of complex meetings. Arrange, coordinate and support meetings, events, and activities both on and off-site. 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 other special projects. Collaborate with Admin team to support complex projects and deadlines General office responsibilities include but not limited to: Schedule and coordinate staff onsite/offsite meetings, create and prepare presentation materials, assist with special projects, schedule travel for staff, process payment and expense reports, maintain files, order department office supplies, maintain photocopying equipment, order catering and other supplies for a variety of meetings and events, greet visitors, disseminate information, fully utilize PC and software applications. Ensure compliance with policies Integrate and facilitate communication with individuals, the team, the department and other functions across the company Attend and actively participate at staff level meetings as required, coordinate/publish agenda and minutes from meetings Integrate and actively participate in administrative associate team meetings and projects as requested The ideal candidate will succeed not just by completing tasks, but by proactively working to maximize the effectiveness of the managers and otheradministrative\nassociates in the group. Provide judgment in sensitive, confidential and complex information. Flexibility to take direction on projects from team and co-workers and work projects yet demonstrate autonomy in managing time and priorities. Proactive problem solving and decision-making within agreed parameters. Customer service orientation. Demonstrated successful experience indicating attention to detail, ability to work independently and in teams, strong follow up skills and ability to manage multiple projects simultaneously. Individual must possess strong, positive interpersonal skills and have the ability to work with diverse individuals. Must be willing and able to handle large volume of routine work, as well as more challenging projects and provide a consistently accurate work product.

The successful candidate will be involved in late-stage pharmaceutical development ofmonoclonal antibodies, antibody-drug conjugates, and delivery systems for clinical evaluation and commercialization. The responsibilities of this role include formulation development, evaluating product stability and throughout the manufacturing process and performance in diverse delivery systems, as well as biophysical characterization, drafting technical documents and contributions to regulatory filings. Applicants should be comfortable working both independently with minimal supervision and as part of a team to support the development of recombinant protein therapeutics. The successful candidate will also be expected to participate on cross-functional project teams. The position offers opportunities for professional and scientific growth in a dynamic, intellectually stimulating and fast-paced work environment.

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).

Level: E4/E5
The position is for a recognized expert and leader as it relates to process and cleaning validation and operations with the ability to gain alignment, advise, coach and train.  This includes expertise in the principles and approaches of process and cleaning validation, and is responsible for leading the continued development, implementation and execution of the process and cleaning programs meeting health authority requirements.  The Principal Technical Manager will develop solutions to complex Quality system and governance issues and initiatives with inter-organizational impact following cGMP regulations and Roche standards.
• Recognized expert and leader as it relates to process and cleaning validation and must have the ability to gain alignment, advise, coach and train Validation and Operations personnel with respect to process and cleaning validation requirements.
• Expertise in the principles and approaches of process and cleaning validation, leading the continued development, implementation and execution of the process and cleaning programs meeting health authority requirements. 
• Develop solutions to complex Quality system and governance issues and initiatives with inter-organizational impact following cGMP regulations and Roche standards.
• Identify and implement solutions to complex Quality system governance concerns and improvement opportunities with multi-site and inter-organizational impact. 

Key Accountabilities:
• Provide Process and Cleaning Validation and Operations expertise to develop, implement, and sustain PQS requirements in accordance with worldwide GMP regulations and Roche standards.
• Act as Global Coordinator for the development, deployment and implementation of the  PQS Product and Process Lifecycle and associated global standards and processes.
• Adhere to Roche’s Quality philosophy and utilize PQS business process and applicable Quality systems, i.e., CAPA and Technical Change Management tools.
• Apply advanced theory, technical principles, expert judgment, and cross-functional expertise to independently address a broad range of complex problems.
• Troubleshoot and direct the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.
Who You Are:
• Collaborative Leadership – Looks for opportunities to help others.  Works well in a collaborative team environment and communicate effectively with customers, peers, and senior management.  Demonstrates respect and appreciation for a diversity of perspectives.  Maintains professionalism in presence of conflict.
• Technical Leadership – Demonstrates ability to provide technical leadership and teamwork in a GxP environment across functional and organizational boundaries.
• Ownership and Accountability – Takes accountability for actions, drives results, and learns from mistakes.  Holds oneself accountable to fulfill assigned tasks and achieve results within timelines.  Initiates additional assignments and assumes responsibilities as appropriate.  Determines methods and procedures on new assignments.
• Communication – Is thorough in capturing all relevant information in communications. Conveys concepts and positions clearly, with straightforward language, both verbally and in writing.  Readily grasps the main points in communication from others.  Asks questions for clarification.
• Planning/Organization – Responds to new requests with appropriate urgency and with an organized approach.
• Problem Solving – Identifies problems, defines problem statement clearly and accurately, and applies structured and disciplined methodology to identify root causes.  Is effective in solution development, risk mitigation, stakeholder buy-in, and execution.
• Customer Focused – Partners with customers and looks ahead to predict future customer needs.  Manages expectations.
• Technology Platform Experience – Has exposure to and expertise in multiple GxP environments.  Executes work in collaboration with multiple technical disciplines.

In this position you will be responsible for managing a framework which allows you to control, administer and deploy many different packages to our Mac population.  You will be charged with managing our inventory/asset management system and responsible for local user policy enforcements, deploying packages, updates and applications, image creation and deployments.  You will be performing thorough internal testing, working with team members on quality assurance and distribute the software via System Casper to the production environment.  In addition to software packaging, this role requires a strong JSS Casper Suite software distribution foundation with the ideal candidate having experience in implementation of machine based distributions on a global scale.

• Defining desktop hardware standards and work with engineering to secure the standard corporate image.
• Implementation and design of software distribution through Jamf/Casper and support distribution points.
• Assist application owners with the planning for the certification and deployment of new or upgraded applications including assisting with the creation of install instructions and test scripts.
• Communicate and collaborate with other IT services providers especially in the supporting areas and project/portfolio managers and ensure that every affected group is communicated to and has signed-off on the stability and readiness of the application/software.
• Participate in all aspects of the application lifecycle for applications supported within the OSX workstation environment. This includes research, analysis, testing, certification, documentation and support. 
• Assist in providing 2nd and 3rd level support with any application issue once deployed.  
• Work with engineering to develop strategies for Genentech’s operations management.
• Work with engineering to design and deploy solutions to the desktop.
• Interact with vendors and functional teams in order to restore services and correct core problems. 
• Perform daily administration, configuration, application integration, functional specifications and development tasks for infrastructure technologies and services.
• Handles and tracks routine incidents and problems and develop support procedures, technical documentation and other related documentation 
• Develop best practices and deployment services for reuse across the enterprise.
• Monitor trends and use the information to suggest and develop continuous improvements to the operations of the solution.
• Work with engineering to document and optimize current infrastructure environment.
• Under limited supervision, responds to and diagnoses problems for enterprise-managed applications and systems and/or routine hardware, software, and network problems. 
• Ability to work in a virtual team atmosphere while being self-motivated with minimum direction in a fast paced environment; as an integral part of a virtual team, you will work closely with other Team members and supporting departments across the globe

It is expected and required that he/she has current knowledge of business processes and IT industry trends and developments.  He/she is expected to have excellent inter-personal and project management skills and team work experience with operations and support staff.  Have delivered and deployed a number of IT services, systems and components.  Additional experience and knowledge of Microsoft System Center Configuation Manager or JAMF Casper Suite and related infrastructure.

The person must have a minimum of 5 year’s experience working in a medium to large company performing infrastructure implementations and operations and excellent knowledge and experience working with information management disciplines such as: server, storage, security, integration and applications. 

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.

The Finance Manager will be part of a team that provides financial planning systems and reporting development, enhancement and maintenance expertise for Roche Canada finance groups and Genentech Commercial finance groups.  The position is located in the United States Eastern time zone and will report to the Finance Manager of Commercial Financial Planning Systems who is based in South San Francisco, CA.  The Finance Manager will be expected to travel to Toronto, Ontario and South San Francisco occasionally – six to eight times per year

The working environment is fast-paced with an ever-changing set of priorities.  The role will interact extensively with the following finance organizations:

We are seeking an outstanding individual for theposition of a Research Associate / Senior Research Associate within theBiochemical and Cellular Pharmacology department. The successful candidate willbe responsible for supporting research projects in the disease therapeuticareas of immunology and/or immunotherapy as part of the biologics drugdiscovery program at our South San Francisco campus. The individual will be expectedto work independently in developing and performing immunochemical, biochemical,and cell-based assays to support candidate selection, potency, efficacy, andpharmacokinetic studies as well as immunogenicity evaluation andpharmacodynamic biomarker measurements. In addition, the individual will incorporateautomation into his/her daily work and apply novel technologies in assaydevelopment.

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 raw materials and DS.  

o...

LOCATION:  San Francisco, CA or Rocky Mount, North Carolina

Description:  This particular position of Principle Site Manager in the North American Steriles CMO organization will have the primary responsibilities of site management of Drug Product Diluents at a Contract Manufacturer.   This role will be a position that will be the “Person in the Plant (PIP)” located in Rocky Mount, North Carolina. 

Job Responsibilities:

* Manage the lifecycle of contract manufacturing activities for commercial products at one or more bulk drug product (DP) 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/Genentech’s commercial and manufacturing strategies and plans.

* Establish and manage business, operations, and quality relationships and communications between Roche/Genentech and the CMO as the Roche/Genentech’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/Genentech 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/Genentech’s DP products at a CMO’s manufacturing facility, specifically:

* Lead the Technology Transfer project for Roche/Genentech 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/Genentech’s DP 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/Genentech’s Site Manager, actively managing the on-going relationship with CMO to ensure Roche/Genentech’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/Genentech 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, ...

Purpose:

This Principle Technical Manager will manage the Quality oversight related to sterile diluents manufactured at a Contract Manufacturing Organization (CMO) located in North Carolina.  This person will be a key member of the CMO governance team to support right to operate and supply of diluents packaged with several critical Genentech/Roche products.

Responsibilities:

·         Influence and drive Right to Operate and continuous improvement to achieve compliant and reliable supply of diluent for Roche products.

·         Establish and monitor CMO Quality goals and metrics to drive continuous improvements

·         Recommend, implement, and drive strategic objectives and goals of the CMO relationship

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

·         Manage the release of product, including batch record review, investigations, change controls

·         Partner with the CMO to ensure proper aseptic control during Roche operations

·         Observe end-to end production activities that include filling, terminal sterilization, visual inspection, and labeling

·         Work with CMO to align requirements for visual inspection of diluent

·         Make decisions if issues arise during production

·         Support validation activities, product complaint investigations, creation of Annual Product Reviews, and other quality functions as required

·         Develop/maintain quality risk management plans and risk logs; utilize risk management tools to identify and mitigate CMO quality and compliance risks 

·         Ensure that CMO meets Roche Pharmaceutical Quality Standards (PQS)

·         Participate in regulatory inspections and GNE compliance audits

·         Develop and negotiate Quality Agreement with CMO

·         Support any regulatory filings for diluent manufactured at CMO

·         Present quality topics to varying governance bodies, such as Quality Review Boards, Operational Review Meetings, and Roche/CMO Steering Committees

·         Serve as the Quality representative on cross-functional and multi-site teams

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

Conduct repetitive, predictive, condition based, reactive maintenance and troubleshooting of production equipment within the PTD Operations and Engineering group.  Assist with engineering and evaluation of existing and new equipment and processes.

Responsibilities:
• Responsible for the maintenance and repair of all mechanical process equipment within PTD Operations & Engineering at the South San Francisco facility
• Conduct general preventative maintenance according to SOPs/work instructions and perform planned and unplanned repairs as necessary.
• Conduct routine inspections and monitoring of equipment and systems.
• Perform troubleshooting of electrical, pneumatic, and mechanical equipment.
• Complete preventive maintenance and assigned paperwork in a timely manner.
• Assist/Manage specialized maintenance and equipment projects as needed.
• Responsible for inputting data to derive performance metrics for management
• Coordinate contractors and work in conjunction with internal business units who perform repairs, modifications, preventive maintenance and installations of mechanical and electrical equipment.
• Provide technical expertise and training to junior staff.
• Assist as a technical SME with identification, purchase, and organization of spare parts.
• Successfully complete training and demonstrate an ability to perform equipment monitoring and operational checks on production equipment.
• Ensure/maintain all process equipment and areas in a constant state of inspection readiness; specifically, but not limited to, the following:
o Cleanliness
o Personnel and equipment safety.
o Area maintained in an organized fashion.
• Continuously evaluate all operational Standard Operating Procedures and Preventive Maintenance procedures for accuracy and applicability.  Submit appropriate change requests to supervisor to correct any deficiencies discovered. Create new SOPs and equipment/system related procedures.
• Interact with PTD Operations and Engineering staff members as well as other internal/external customers.
• Follow established safety and environmental guidelines and procedures for all work performed. Immediately report safety and environmental incidents including injuries, illnesses, near misses, and safety suggestions. Foster a positive safety culture.
• Respond to emergency call-in when regular scheduled personnel are not available

• Manage and track the Validation program and assigned validation projects and ensure target
• timelines are met and/or issues are communicated / escalated effectively and consistently.
• Generate, review, approve and maintain Validation Project Plans and Summary Reports and other validation lifecycle documents.
• Generate, review and approve a variety of Validation protocols (IQs, OQs, IOQs, PQs, SIP, CV) for equipment.
• Manage protocol execution, perform data review and manage deviation resolution.
• Oversight and management of validation contract resources including work prioritization, execution and contractor budget.
• Strong understanding of commercial production environment and requirements.
• Evaluate and audit the current validated status of equipment/systems temperature mapping and cleaning validation program.
• Proven ability to make suggestions for improvements as well as ensure programs are operating in a compliant and validated state.
• Present validation packages as required for audits and/or regulatory inspections.
• Perform role of subject matter expert and assess change control and discrepancy events for to validated systems.
• Review validation lifecycle documents for compliance with CFRs, corporate policies (QP/QS documents), and site procedures (SOP’s).
• Participate in cross-functional team meetings and where required, lead/facilitate meeting.
• All employees with jobs that require access to the Warehouse must be able to pass the
• Transportation Security Administration (TSA) Security Threat Assessment (STA).
• Ensures there will be integration of environmental health, safety, and security into the business processes, systems, and programs while reporting safety and environmental incidents including injuries, illnesses, and safety suggestions within their functional area.

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 ...

Objectives and Scope of Position:

• Responsible for the preparation of regulatory documents for submission to regulatory authorities within subject area (clinical/safety). This role involves working in close partnership with the medical/scientific content owners in the relevant functions
• Takes accountability for delivering regulatory documents and works effectively and closely with key content owners 
• Applies document and project management expertise
• Contributes to the functional excellence of regulatory documentation (process management) 

Primary Responsibilities and Accountabilities

• Prepare regulatory documents in accordance with applicable regulatory guidelines/Roche standards/SOPs, ensuring high scientific quality & consistency with other documents where appropriate
• Liaise with document contributors to gather information (including Licensing partners where relevant)
• Plan & create timelines for the production and review of documents ensuring alignment with overall project timelines where appropriate
• Review documents for: organisation/clarity/use of English language/grammar/scientific standards/consistency between textual presentations and listings/tabular or graphical displays 
• Manage the review process, including leading/coordinating adjudication of review comments and incorporating review comments
• Participate as a member of key functional/cross functional Team (s) (e.g. Regulatory Area Functional Team, Safety Team etc), ensuring that Teams adequately plan for document deliverables
• Ensure that the document is published in collaboration with Regulatory Operations and that the document is approved by the single accountable signatory

In addition as a Senior Regulatory Documentation Scientist

• Manage the preparation of a suite of regulatory documents e.g. Clinical Dossier, suite of Safety Documents
• Lead Writing Team for preparation of Clinical Dossiers/Safety Reports
• Review documents to ensure adherence to documentation quality standard, regulatory requirements and consistency of messages across all documents for a product/across clinical documents within a dossier
• Prepare specifications for outsourced work (writing/review of documents) and serves as Roche liaison for project purposes
• Plans and creates timelines for the production of assigned documents e.g. Clinical Dossier/Suite of Safety documents. Ensures proper planning and resourcing of all documents assigned to Writing Team including what work or portions of work to be outsourced
• Actively contributes to best practices and continuous improvement within Regulatory Documentation. Represents the group in functional and cross functional initiatives/projects when 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.

The North America Commercial Group generates $13B in sales and includes 4000 employees, 1500+ reps, and major sites in South San Francisco, Nutley, Indianapolis, Vacaville, Hillsboro, and Mississauga.  The US affiliate is organized into Business Units such as BioOncology, Immunology/Ophthalmology, Virology, and Metabolism as well as organizations like Business Operations, Managed Care, and Customer Operations.  Since 2008, all major technical solutions and components supporting Genentech US Commercial Operations were replaced or upgraded, then extended to support Roche Canada.  The Commercial IT team continues to implement innovative technologies to best enable the business stakeholders.

The Programmer Analyst will provide technical expertise to the Application Services - Sales & Marketing team supporting the North America Commercial Group.  This position focuses on the continuing evolution, implementation, and support of existing and new vendor-based systems to support critical business processes.  The Programmer Analyst will work with a Poland-based development team and onsite contractors as needed to complete deliverables.  

Key Responsibilities:  

• Participate in business process analysis, use case creation, and requirements definition.
• Responsible for designing, prototyping, developing and unit testing solutions for projects and maintenance & enhancement releases.
• Create and maintain technical specifications, system interface diagrams, unit testing scenarios and system support documentation.
• Follow best practices and standards to ensure technical compliance.
• Provide root cause analysis to resolve complex issues as part of support.
• Work on multiple priorities at the same time and manage the work/time effectively.
• Demonstrates accountability by contributing to the completion of assigned tasks.
• Participate in projects as assigned.