Director, Manufacturing Science and Technology
Description:
? We are seeking a dynamic and experienced MSAT Director to support late-stage development through launch/commercialization activities.
? Central to success will be engaging with CDMO(s) to deliver processes that enable robust production of Drug Substance (DS) for monoclonal antibodies.
? This interdisciplinary position will provide expertise across cell line, cell culture, purification, and formulations, including scale-up from lab to manufacturing scale.
Requirements: ? BS, MS, PhD in relevant discipline (e.g., biology, biochemistry, biochemical engineering, or relevant field) or commensurate years of education and experience ? 10+ years biologics development and manufacturing experience ? Experience with late phase development and commercialization of biologics within relevant process areas (upstream cell culture, downstream processing, solution prep, cleaning, automation, data systems, etc.) ? Experience with tech transfer to CDMOs and supporting DS campaigns through... scale up and validation ? Experience with process and economic modeling of DS manufacturing processes ? Demonstrated aptitude in collaborating with cross-functional partners, including clinical development/operations, analytical development, QA, RA, and supply chain. ? Excellent communication skills with an ability to present to a variety of stakeholders and tailor message accordingly ? Demonstrated growth mindset, willing to learn from others, and dedication to promoting a psychologically safe environment ? Ability and willingness to travel up to 25% including to CDMOs ? Ability to multi-task and keep pace with a fast-moving organization ? Availability to participate in calls across multiple international time zones
Benefits:
? A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless
? Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
? Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
? Flexible PTO
? Two, one-week company-wide shutdowns each year
? Commitment to growing you professionally and providing access to resources to further your development
? Apogee offers regular all team, in-person meetings to build relationships and problem solve
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