Director - Biologics Downstream Process Development This position is responsible for leading the Biologics Downstream Process Development Team in taking Alkermes' biologics candidates from discovery through process development, scale-up, optimization, process characterization, tech transfer, clinical production, validation and commercial launch. The Team will also work with external development and manufacturing organizations. The Biologics Process Development labs will be located in Waltham, MA with scale-up capabilities up to 200 L scale. This position will lead a group responsible for: Downstream process development, scale up, and optimization Process Characterization and Control Strategy Development Tech transfer to CMO/CDMOs Support validation and commercial launch Technical support to CMOs for deviations and investigations Qualification of new vendors and CMO/CDMOs Authoring and reviewing technical reports and relevant regulatory submissions Supporting the Regulatory group in responding to agency questions In-depth knowledge in GMP systems, sterile processing, and US/EU requirements Manufacturing tox and clinical supplies Working closely with Biologics Discovery, CMC teams, and Technical Operations to ensure product success Education / Experience Qualified candidates should have a PhD in Engineering with 15+ years technical and management experience in biopharmaceutical based process development and GMP manufacturing with an established track record of successfully developing and commercializing biologic products and processes. Skills / Attributes Needed Leadership & Management Strong leadership qualities (integrity, honesty, empathy, confidence, inspiration, commitment, passion, good communicator, decisive, accountable, delegates, empowers, creative/innovative) A collaborative, passionate, empathic personality with excellent interpersonal skills that positively influences the group culture and team dynamics Active participation in team environments and freely offers constructive opinions and suggestions with the expectation they will support their teammates to assure project success Ability to lead and influence technical teams and mentor less experienced scientists and engineers Foster a culture of continuous improvement and operation excellence < > Detailed understanding of science and engineering principles along with up to date knowledge ofupstream biologics processing technology and regulatory expectations Experience with developing process for novel modalities and non-antibody recombinant protein products expressed in mammalian cell culture Experience in downstream biologics process development, scale-up and optimization along with a strong understanding of analytical technologies that can help enhance process understanding Demonstrated expertise and understanding of downstream unit operations such as chromatography, UF/DF, Depth Filtration, Centrifugation, Nanofiltration and viral clearance steps Experience with pilot scale operations and large scale equipment Energized solving technical problems, learning, creative thinking, and critical analysis and is committed to taking action and getting results Demonstrated knowledge and experience in designing experiments (DOE) and establishing operating ranges as well as establishing control strategies 9620Salary Range: NAMinimum Qualification15+ years Associated topics: bio, bioinformatic, biomedical engineer, biophysics, bioprocess, enzyme, hereditary, medical, msat, parenteral
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