Genentech Partnering is seeking a Manager / Sr. Manager to join the Technologies Business Development Group. The Technologies Group executes strategic collaboration and licensing agreements to support therapeutic lead discovery and companion diagnostic development by Genentech.

Responsibilities will include working in close collaboration with internal scientific stakeholders to establish strategy and prioritization for accessing external technology platforms, defining key technology criteria, actively seeking out opportunities that meet criteria and coordinating due diligence activities.

The successful candidate will lead negotiations with prospective partners on behalf of Genentech, creating collaboration structures that align with scientific and business needs, and will be responsible for making deal recommendations to Genentech senior management.

The BD Manager / Sr. Manager will work extensively with scientists in Genentech’s Research and Development Sciences departments on technology assessments and due diligence and with colleagues in the Legal and Finance departments on deal structuring, financial valuations and contract negotiations.

This position will report to the Director, Head of the Technologies & Diagnostics Group in Genentech Partnering.

E4/E5

The purpose of the role is to provide high quality evaluation and sourcing of oncology, hematology, and tumor immunology opportunities.  This individual will also lead confidential due diligence evaluations and pursue BD licensing and partnership opportunities.

Job Duties/Responsibilities:

Responsible for screening potential oncology collaboration opportunities.

Lead more detailed diligence on selected high priority deals as part of diligence teams.

Provide effective liaison with Early Clinical Development.

Serve as a member of the Oncology Portfolio Committee.

Proactively source appropriate opportunities for GNE consideration from academic, literature, trade publications, meetings, etc.

Education of other BD professionals, including reviews of technical literature.

As appropriate, pursue BD licensing and partnership opportunities.

Data Management Manager / Sr. Manager

Data Management Manager / Sr. Managers act as subject matter experts and lead contacts for Commercial Operations’ Customer Master Data. The Master Data Management function and team are responsible for development and management of all Commercial Operations’ Customer Master Data operations and projects, including analyzing and matching master data with customer data, reconciling and validating data, systems or database upgrades and ongoing management, attending to ad hoc data requests, and leading and/or participating in special data projects that impact Commercial Operations’ Customer Master Data. Like other Data Management teams, Master Data Management works closely with a host of internal partners, including Genentech’s Commercial Operations Informatics (gCOI), as well as external data or IT vendors/consultants. Data Management Manager / Sr. Managers are typically assigned the largest or most complex projects or other operations to support and they may also people management responsibilities for one or more direct reports. Incumbents in the Data Management Manager / Sr. Manager role, as all other employees, are fully accountable for compliance with all laws, regulations and policies that govern the conduct of GNE activities. As a manager of others, the Data Management Manager / Sr. Manager is not only accountable for his/her own compliance, but also for the compliance of all individuals in his/her team. As such, leads the way and leads by example by demonstrating full knowledge and commitment to all applicable policies. Monitors adherence to company policies and guidelines and acts according to established procedures to ensure all issues are addressed and resolved as required.

Incumbents in the Data Management Manager / Sr. Manager role are generally expected to:

• Act as lead subject matter expert for Commercial Operations' Master Data Management operations and projects. Including leading and/or otherwise supporting the largest and/or most complex projects or other operations: 

• Identifying new business rules to support best-in-class customer master data
• Expertly leading data analysis, extraction, matching, reconciliation and validation activities with the highest possible levels of accuracy and timeliness
• Consistently complying with all Genentech IT protocols, procedures, standards and other relevant business requirements
• Expertly fulfilling other ad hoc requests and leading special data projects, which includes upgrading and launching new systems or upgrades
• At all times, ensuring all work is completed on-time and on-target to fully meet or exceed expectations, goals and targets
• Developing and maintaining excellent working relationships with customers, partners and other stakeholders; providing the highest quality customer service and following established departmental protocols, policies and procedures

• Act, and is accountable for others in his/her team acting, in complete & total compliance with all laws, regulations and policies
• Manage the overall relationship with master data vendors
• Utilize only approved resources and messages to meet goals and targets
• Where assigned, recruit, hire, and develop direct reports, as well as oversee their work to ensure assigned goals, objectives and targets will be met or exceeded
• Effectively and efficiently train end-users and/or other customers, partners or stakeholders on Commercial Operations’ Customer Master Data operations, content, usage, applications and the like
• Support his/her manager and other team members in training and mentoring less experienced analysts
• Participate, as and when needed or otherwise appropriate, in cross-functional or other project teams; helping the overall business of Genentech to continuously evolve, improve and excel

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:

• Acts as lead of market planning team and primary contact for Market Planning projects and customers
• Supports strategic decision making across assigned areas/responsibilities; helping internal partners/stakeholders to maximize their commercial success
• Proactively evaluates/assesses the relevant market landscape, monitoring changes in market dynamics, competition, clinician and patient practices and needs, as well as other related factors
• Acts as a thought partner and consultant to assigned teams, functions and other relevant partners/stakeholders
• Partners with brand directors and other stakeholders to review and contribute to lifecycle, brand and tactical plans and provide supportive insights to help further inform, shape and influence business strategies and plans
• Provides long-range business plan forecasts for assigned brands
• Where appropriate, may partner with others, to review and integrate product- and market-specific assessments, analyses and the like into portfolio-wide (across all Genentech therapeutic areas and/or beyond) assessments for executive level reviews and decision-making
• Where assigned, helps internal partners/stakeholder to identify and set key performance metrics for assigned brands
• Employs a wide range of market analysis efforts and techniques, including penetration assessments, market share analyses, product concept testing, etc.
• Provides the continuous, in-depth cumulative perspective on the relevant market(s) and brand(s)
• Acts as the expert on the customer landscape, providing in-depth information and insights into customer practices and needs. As such, also possesses and applies in-depth product and therapeutic area knowledge
• Uses his/her understanding of the "broader market" to link insights and recommendations to wider strategic issues, challenges and/or opportunities:
• Synthesizes relevant analyses and prior research findings to develop a cumulative perspective of the relevant market(s) and associated factors; translates such into clear and meaningful implications for communication and review by internal partners and other stakeholders
• Recommends research/analysis methods and matches these to project objectives; understanding potential and/or limitations of various sources and methodologies
• Draws substantive conclusions from results; identifying implications, challenges or other opportunities and delineating clear next steps
• Develops a "command" of data/info sources and a sensitivity to biases
• Performs accurate analyses and thinks creatively about different ways to analyze data and information
• Defines questions and required data; appropriately comprehends quantitative methods and analysis techniques
• Identifies themes across projects and information sources; performing appropriate, aligned and integrated "meta-analyses"
• Where assigned, tracks key performance metrics for assigned brands
• Where assigned, creates, validates and refines forecasts for in-line products, new indications and new market opportunities. Presents updates on revenue information to senior management
• Where applicable, hires, develops and oversees the work of direct reports
• Complies with all laws, regulations and policies that govern the conduct of Genentech activities

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 ...

This position is responsible for providing leadership and direction to a purification process development group in Purification Development.  The candidate will lead a team of 12-18 staff comprised of several groups of scientists and engineers and be responsible for the management and leadership of multiple early stage and late stage development and technology projects.  A high degree of initiative is expected to assess new areas and directions critical for Pharma Technical Development and Genentech’s future success.  Strong management skills to lead, motivate, and develop staff in their group is a key requirement for this position.  The candidate is expected to provide leadership to their groups and throughout Purification Development and across Pharma Technical Development.

Responsible for producing innovative biotherapeutic medicine by interfacing with highly automated production systems and controls in cGMP manufacturing environment, and maintain areas in high state of inspection preparedness. Operates production equipment for cell culture or purification that may include culture growth, process monitoring, sampling, harvesting, purification, formulation, freeze thaw and transfer. Performs media/buffer solution preparation operations. Maintains records and clean room environment to comply with regulatory requirements utilizing current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP).

Responsible for assisting the shift supervisor by ensuring production goals are met throughout the day and distributing work assignments to technicians.

Job Responsibilities:
Lead TechnicianLead, coordinate and assign daily operations that include work tasks, breaks, and lunches. Provide coaching and training on technical aspects of the job, best practices and compliance to SOPs.

Assist Supervisor with meeting production quality standards by verifying the environment is in compliance with safe standards and SOPs are followed. Assist supervisor with approvals, communications, and improvements. Identify areas for operational improvement. Provide data to supervisors summarizing schedule status. Resolve employee conflict independently and with supervisor.

Job Matrix
Through knowledge of biopharm technology, processes and the underlying scientific concepts.
Must demonstrate a comprehensive understanding of both general and specific aspects of multiple manufacturing departments.
Troubleshoots, investigates, and escalates complex problems, works with others to implement solutions.

Technician: Operate systems that clean and sterilize tanks and filtration systems.
Prepare solutions for the production process.
Review documentation and check all calculations (e.g. tickets, labels, equipment reading).
Trouble shoot equipment and process problems.
Comply with safety requirements, cGMP, SOP and manufacturing documentation.
Use of automation to perform production operations.
Provide support to Manufacturing to meet production demands.
Operate automated systems for equipment operation.
Assemble and prepare equipment for production.
Exhibit detail oriented documentation skills
Communicate effectively and ability to work in a team environment.
Exhibit professional interpersonal skills.
Work with coworkers and supervisor to effectively troubleshoot equipment and process issues.

Position: Principal Business Process Excellence

Location: Basel or South San Francisco

Summary:

Team Overview:

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

Position Overview:

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

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

Responsibilities: 

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

Requirements: 

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

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

* Develop conceptual customer needs into an approved project charter

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

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

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

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

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

Competencies:

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

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

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

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

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

Main Purpose of the Position:
• Supervise and develop staff completing Change Control activities and drive resolution of complex change control issues following cGMP regulations and Genentech standards. 
• Supervise performance and development of direct reports to ensure achievement of organizational and department goals and a productive environment.

Job Duties/Responsibilities:
• Manage and administer all aspects of people processes related to the employee lifecycle.  This includes the selection, hiring and training of personnel on company and department policies, systems and processes.  Manage and communicate compensation related information per company guidelines.
• Coach and develop staff by providing an environment that encourages ongoing personal and professional development.  Manage and ensure the setting of realistic personal goals for staff and provide regularly scheduled feedback throughout the year.  Ensure staff receives appropriate knowledge and skill development and growth opportunities.
• Determine and communicate objectives and accountabilities for direct reports.
• Regularly review staff progress in meeting objectives.
• Recommend improvements to Quality operational policies, plans and procedures.
• Ensure activities are completed on time and issues resolved within budget.
• Make recommendations to department budget and staffing needs.
• Notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
• Participate in continuous improvement initiatives for Genentech Quality Systems.
• Sign documents for activities as authorized and described by Genentech policies, procedures and job descriptions.
• Be accountable for behaviors described in Genentech’s Core, Common and Critical Competencies.
• Perform any other tasks as requested by Senior Management to support Quality oversight activities.

Technical Duties/Responsibilities:
• Oversee the impact assessment of proposed changes and ensure appropriate approvers are selected for changes.
• Supervise change control activities for validated systems, qualified equipment, and controlled documents.
• Participate in cross-site change management forums. 
• Supervise staff conducting change control activities for quality and business systems support in GMP areas. 
• Participate in business process improvement programs and process redesign initiatives.
• Promote and provide guidance in Good Documentation Practices. 
• Supervise lot release restrictions imposed by system, process, method and equipment changes.
• Ensure the completion of required actions prior to lifting lot release restrictions. 
• Assist in developing training content and qualifications for change control processes and change management applications. 
• Act as a resource for Change Control knowledge management within Quality Operations and across site Quality departments.  
• Collaborate with site Quality and Production units in the administration, access, and communication of the Change Control system.
• Participate in change control automation and business process improvement initiatives. 
• Supervise Record Management, Retention and Repository program activities and processes.
• Collaborate with Quality and Production departments to maintain GMP records.
• Ensure backup and disaster recovery system activities are implemented and maintained for critical GMP records. 
• Ensure data integrity and recoverability of electronic GMP records according to Genentech policy.