Biomanufacturing Specialist Lead - Production (Molecular Medicine)

The Biomanufacturing Specialist Lead is the primary process development and/or manufacturing expert supporting the production of regenerative products via approved standard operating procedures (SOPs) and product validation for FDA-regulated, CGMP manufacturing operations. Primary responsibilities include meeting product integrity and quality produced for internal and external clients. Scope of the position includes effectively leading CGMP-related development and manufacturing teams during the planning and execution phases of activities as well as monitoring the strict adherence to approved CGMP-compliant development and manufacturing SOPs by staff.

Minimum requirement of a bachelor's degree in a biomedical related field (e.g. biology, cell/molecular, bioengineering, laboratory medicine, etc.) and 10 years relevant experience in a complex research and/or manufacturing environment, or a Masters degree and 6 years relevant experience in a complex research and/or manufacturing environment, or a Ph.D. and 4 years relevant experience in a complex research and/or manufacturing environment. Experience in a cGMP environment manufacturing clinical-grade human cells, biologics, biomaterial, or other product intended for human use is preferred.

Additional Qualifications:

Must have strong experience in developing and observing SOPs and track record of leveraging this experience to develop, qualify, and launch innovation. Products manufacture experience in both Upstream/Front End and Product manufacture/Qualification. Experience coaching others in biological products manufacture. Strong collaboration skills and experience partnering with other functions to deliver results. Ability to effectively communicate complex ideas to a variety of stakeholders across functions through multiple forms of communication, including formal presentation skills. An understanding of the application of laws, regulations, and guidance documents related to FDA regulated industries (biologics, pharmaceuticals, devices, etc.). Exceptional human relations and communication (written, verbal, and listening) skills are required. Organizational project management skills are essential, along with analytical and critical thinking abilities. Must be flexible and capable of adapting to and facilitating change. Must have demonstrated capacity to comprehend complex protocols, programs, and situations. The ability to exercise good judgement while working under deadlines is required. Must be flexible with work schedule as needed to meet internal and external customer needs. Must be self-motivated and able to independently schedule workday activities with minimal direction.

Position opening is for a Biomanufacturing Specialist Lead in the Viral Vector Production Laboratory (VVPL). This Biomanufacturing Specialist Lead will be responsible for managing manufacturing operations, including process development, pre-clinical production processes, and GMP processes for a variety of viral vectors and cell lines. The candidate will be expected to work independently and in teams to perform, supervise, and develop viral production processes, adapt processes to comply with current Good Manufacturing Practices (cGMPs); manufacture products using cGMPs for use in human clinical trials; develop and perform experimental studies and quality control assays for viral products; and develop, write, review and follow VVPL standard operating procedures.

The successful candidate must have extensive, advanced experience in cell culture procedures. Candidates must have experience in virological techniques, large-scale culture and/or purification processes (particularly for AAV and Lentiviral vectors), processes using GMP, AND/OR development of written standard operating procedures. Candidates who meet more than one of the above criteria are preferred. This position requires attention to detail and meticulous record keeping and documentation. This position also requires excellent interpersonal skills and the ability to lead and motivate biomanufacturing team.

Physical activity routinely requires lifting and moving materials and equipment of 20 - 30 pounds. GMP production processes are performed in a cleanroom laboratory and require wearing personal protective equipment including an environmental sui

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