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The following opportunity exists in our South San Francisco, CA facility:Sr. Group Leader/Assoc. Director, Pharma Dev't Engineering Pharma Technical Development
Job ID: 1000034147
South San Francisco, CARESPONSIBILITIES: Associate Director/ Senior Group Leader, Pharmaceutical Development Engineering
Description: Responsible for leading pharmaceutical development engineering activities for drug product processes to facilitate interaction between process and equipment related engineering activities. The leader of this group will provide strategic direction for the group and across the engineering network to assure that our work is well integrated into broader efforts. Though the group will reside in LSP&PD to foster detailed understanding and close alignment for the significant number of engineering needs with our late stage and commercial projects, this group will be expected to provide excellent Support to the entire Pharmaceutical Development organization including ESPD, Drug Delivery and Device Departments and to our partner groups primarily at SSF but including transfer to and Support of development related activities through out the Roche Pharma network and at CMO's. This position will lead a group of approximately 15 engineers and scientists.
Responsibilities:
Develop, implement and oversee all activities related to Pharmaceutical Development Engineering including:
-developing novel processes, equipment and technologies
-prioritizing & overseeing technology development
-implementing processes for individual molecule projects
-providing SMEs for all drug product processes
-overseeing, implementing and executing drug product process characterization and validation programs and activities
-overseeing and implementing equipment related process development activities
-technical transfer of processes between sites
Play a key role in troubleshooting processes and equipment for clinical and commercialManufacturing.
Provide leadership and management of staff including performance management and career development.
Provide strategic leadership for the LSP&PD, Pharmaceutical Development and TRD organization.
Foster teamwork among colleagues
Prepare regular reports regarding activities, schedules, resources and budgetary needs and communicate to Director and senior management
Provide a single point of contact for interacting with key partner groups across Genentech and the broader Roche organization.
Requirements: The successful candidate will have demonstrated excellence in leading and managing engineering projects related to drug product processing and equipment. The candidate should have a Ph.D. in an engineering or related discipline with 10+ years experience in protein therapeutic industry engineering (candidates without a PhD with other compensatory experience will be considered). They will demonstrate a solid understanding of phase appropriate GMP requirements and US and European regulatory requirements as relating to the processes they oversee. They will have 7+ years of supervisory experience. The successful candidate is expected to demonstrate excellent leadership skills and strong teamwork and collaboration skills. Travel may comprise 15% of their time.
DIVISION: Pharma Technical Development
REQUISITION NUMBER: 10-1000034147 Genentech is dedicated to fostering an environment that is inclusive and encourages diversity of thought, style, skills and perspective. To learn more about our current opportunities, please visit: http://careers.gene.com and reference Req. # 1000034147 . Please use ?Web ? BAJobs? when a source is requested. Genentech is an Equal Opportunity Employer. | | |
