Genentech, Inc. in San Francisco
The Director of Global Manufacturing Science and Technology (MSAT) is responsible for providing leadership, strategic vision, process management, tactical execution and business acumen for the ongoing technical support of Genentech’s commercial manufacturing drug substance and drug product processes across the internal and external manufacturing network. In this role, she/he will be accountable for process improvements, technical support, and tech transfer of commercial products. The organization will consist of a global team along with dotted line accountability to the site MSAT heads. The successful candidate will play a critical link between PR&D and PROP.
The successful candidate will also be accountable for the Product Technical Teams (PTTs) which are responsible for commercial CMC process governance and improvement across the network.
Key Accountabilities & Responsibilities:
1.Provide strategic context and technical input to facilitate decision making for manufacturing network and commercial product management. Provide technical leadership on various governance committees and decision making bodies, including PR&D Sr Staff, BMLT, CMC RC, PROPR, Biochem Best Practice Forum, GMP CT, Process Validation Management, & Raw Material Review Board (RMRB). Coordinate PR&D budget for commercial product and process support and improvement.
2.Chair MSAT Leadership team, accountable for MSAT support throughout the network. Team coordinates activities and resources on network objectives such as manufacturing site selection, Technology Transfer, QP/QS development and gap closure plans, Manufacturing Technology KFA and adapting innovative technologies into Manufacturing.
3. Complete execution of Manufacturing Network Optimization, which includes technology transfers to transition SSF plant to a clinical center of excellence, and plant start-up support for Singapore plants, HFF, and CCP2.
4.Serve as business process owner for BOM (bill of materials) on behalf of PR&D. Work with CMC teams and PR&D functions to improve delivery of process and product definition to meet the data requirements for SAP/MES systems.
Job Requirements: *Undergraduate degree in life sciences/engineering required, advanced degree in life sciences/engineering preferred *10+ years experience in the biopharmaceutical industry, including 5 or more years of senior level management experience required *Experience in bioprocess manufacturing required *Excellent leadership skills with the ability to motivate a team with dotted-line reporting relationship. *Effective skills in both project and people management *Demonstrated ability to drive for results and lead innovation and change *Demonstrated command of tools and techniques of formal process management and improvement methodologies (Operational Excellence, Class A) *Ability to effectively communicate and influence across all levels of the organization both internal and external to Genentech, Inc. *Demonstrated success in business process/system development, influence management, collaboration and change management. *Excellent oral and written communication, facilitation, collaboration and presentation skills
The successful candidate will be an excellent leader – with strong technical abilities and organizational capabilities – a dynamic and driven individual. The ideal candidate will thrive on challenge, foster an environment of collaboration and possess superior abilities to influence at all levels of the organization. Most critical to the above, the Director must be able to communicate and implement a compelling vision to leaders across multiple organizations and objectively represent the integrated technical perspective for decision making in PROP.
Published at 05-11-2010
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