Bayer Associate Director, Drug Product Manufacturing Sciences in Berkeley, CA, California
Your tasks and responsibilities
The primary responsibilities of this role, as Associate Director, Drug Product Manufacturing Sciences, are to:
•Actively manage and provide strategic guidance to two or more Manufacturing Science (MS) Drug Product groups and the MS Laboratory group, comprising of about 16 technical experts and Senior Managers who are in turn responsible for comprehensively meeting scientific support needs of all Drug Product manufacturing operations and MS Laboratory Functions on the Bayer Berkeley site. Strategically review all Drug Product processes at the Berkeley site and create a multi-year focus to improve process understanding, enhance compliance and process robustness; •Provide strategic direction to MS Laboratory comprising Cell Culture, Downstream Purification, Fill Finish and Protein-Analytical Scientists to ensure application of suitable methods for process characterization, high-throughput process development and analytics...Ensure alignment between Lab Capabilities and MS-driven or Site-driven priorities and direct Lab to maintain a constant state of readiness to flexibly address needs. Drive a culture of safety and compliance within the group; •Ensure strategic alignment between API process stages and Drug Product manufacturing in the Berkeley Site and across the Bayer Factor VIII network. Coordinate activities with Bayer AG and other outside resources for the transfer of process knowledge and technologies involving the Berkeley facilities; •Represent the site as Drug Product technical lead in regulatory interactions and as SME in external meetings and cultivate and maintain an active network with key opinion leaders and industry experts; •Benchmark group with best-in-class Manufacturing Sciences organizations, and drive to build an industry leading organization. Develop best practices and strategic initiatives to facilitate state of the art Factor VIII Drug Product manufacturing understanding and knowledge amongst all Drug Product manufacturing sites in the FVIII network. Devise innovative approaches to problem solving and provide technical, organizational guidance and mentorship to ensure that scientific rigor is maintained in all aspects of Manufacturing Science operations; •Recruit, hire and mentor technical leaders. Develop staff to improve technical and management skills through education and other opportunities. Ensure full cross-training to improve overall competency, skills and effectiveness of the group. Empower reports to make decisions; •Manage projects with global scope to achieve key site goals. Communicate frequently with site leadership to provide guidance on key technical issues; •Provide effective leadership including: individual goal setting/performance reviews, managing the development of employees, recognizing and appreciating employee contributions, mitigating conflict and communication problems, planning and facilitating team activities, selecting personnel and motivating members of the functional area; supporting workforce diversity, quality and safety and supporting supervisors in the management of their employees/department which support achievement of individual/department/business objectives.
Who you are
Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:
•Bachelor of Science 12+ •MS 10+ •PhD 8+ •Manufacturing experience in pharmaceutical operations, preferably biotech of which 5 years include managerial experience or an equivalent combination of education and experience. Advanced degree is preferred; •Expertise in biopharmaceutical Drug Substance manufacturing including mammalian cell culture, cell separation and downstream purification, Knowledge of aseptic pharmaceutical filling technology including isolators and lyophilization is necessary. A detailed knowledge of the equipment, process flows and technologies used in the drug product production of therapeutic proteins is necessary. A strong understanding of protein chemistry, stability and formulation of biopharmaceutical is highly desirable. Specialized knowledge is required for a wide variety of process methods, equipment, occupational and process safety and regulatory requirements to produce therapeutic proteins; •Proven experience in managing and developing teams of 5-20 scientists and engineers of diverse academic backgrounds and skill levels; •Must have an established track record for recruiting, training, delivering results and strong decision making; •Must have a strong customer service focus and ability to develop innovative approaches to problem solving to ensure sustained process robustness and high efficiency; •Scientific depth and demonstrated expertise in the field with knowledge spanning drug development, process development, cGMP manufacturing, quality and regulatory requirements for biopharmaceutical drug manufacturing. Strong analytical skills to identify risks and prepare balanced decisions and ability to support due diligence efforts as technical experts; •Must have demonstrated expertise in managing projects with broad and complex scope and and effectively manage up and down within a matrixed organization. Familiarity with CMC tech-transfer; •Must be proactive and demonstrate high personal integrity; •Motivate, mentor and coach staff to perform to the highest professional and ethical standards; •Must be able to establish a collaborative culture within the department and across functional and cross-site partners.
Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.
Bayer is an Equal Opportunity Employer/Disabled/Veterans
Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.