The Analytical Development group is seeking an Associate Director to champion the success of the Analytical Methods Transfer (AMT) group within analytical development. The selected individual will report to the Director of Analytical Development. Responsibilities will include ensuring the success of all protocol driven activities (Method Validation, Qualification, Verification and formal Technical Transfer), resourcing allocation and forecasting, delivery of project milestones, development of personnel, operational excellence initiatives and first line escalations within AMT.
The successful candidate will directly manage a team of technical leaders/managers to achieve project milestones and will indirectly provide technical and scientific leadership to manage the success of the full group of scientists. The candidate will collaborate with Analytical Development to receive methods and with Quality Control to whom they will transfer methods and train analysts on incoming methods to support manufacturing. The successful candidate will also work closely with program management to set the prioritization of project milestones and to communicate that prioritization to their technical leads. The candidate must have broad technical competence across biochemistry, microbiology and bioassay disciplines to enable swift resolution of technical and scientific challenges and manage meeting deliverables internally and externally.
The successful candidate requires the following knowledge, skills and abilities:
- Demonstrated expertise in the development, design, execution and management of qualification/validation/verification/technical transfer of a broad range of analytical methods for release and in-process cGMP testing of therapeutic proteins (especially chromatography, capillary/traditional electrophoresis, spectrophotometry, plate based methods and microbiology (bioburden, endotoxin, culture purity)) to support the development and cGMP manufacturing of recombinant biopharmaceutical proteins
- Experience with management of high performing scientists and proven understanding of how to foster the growth and development of the careers of a team
- Direct experience supporting regulatory and internal audits
- Project planning, including timing, execution of deliverables and resource allocation to meet the dynamic schedules of multiple parallel programs
- Experience working in a contract manufacturing or testing organization
- Demonstrated communication and interpersonal skills, including confident presentation of data, positive and lasting collaboration with colleagues across departments and cultures, forging positive relationships with external clients, the ability and confidence to challenge others when necessary and strong problem solving skills (training in Lean Six Sigma is preferred)
- Experience creating and managing efficiency improvement initiatives within a team
- Experience working in a regulated cGMP environment
- Excellent oral and written communication skills as well as demonstrated expertise with Microsoft Excel, Project, Word and Google docsThe position typically requires a PhD and 12+ year experience or MS and 15+ years’ direct experience within the biopharmaceutical manufacturing industry working in the analytical field.
FDBU works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 – 130 and Export Administration Regulations in 15 C.F.R. Part 730 – 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Company’s ability to secure an export authorization. FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class.
FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class.