Biomanufacturing Specialist Lead - QC (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 quality control operations, including overseeing, performing, troubleshooting and improving established assays and for development of new assays as needed to ensure VVPL products meet specifications prior to batch release for clinical use in human patients. VVPL is a federally-regulated, cGMP manufacturing laboratory that produces pharmaceutical-grade virus products for use in early Phase I/II clinical trials. The Quality Control (QC) unit of the VVPL performs testing on manufactured products and in-process intermediates to ensure regulatory compliance, integrity, and quality of manufactured products. The VVPL also aids internal and external clients with quality control testing matters related to virus and cell line products as required.

The successful candidate must have the ability to work independently and have a broad range and depth of experience in laboratory analysis, including: analytical instrumentation, assay development, method evaluation, statistical analyses, using and writing standard operating procedures, and the use of quality control to monitor assay performance. Excellent analytical skills, documentation practices, written and verbal communication skills, and attention to detail are imperative. Candidates with experience in GxP related analytical processes, particularly analytical chromatography are preferred. The QC Manager trains and oversees the work of other QC staff and must work as part of the VVPL team with production staff, the QA unit, the VVPL Manager and VVPL Director.