Director - Drug Product Development

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Apogee Therapeutics

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Immunology & Inflammation

51 - 200

💰 $149M Series B on 2022-12

Description

• We are seeking a Director of Drug Product Development to develop protein drug product presentations and processes, oversee tech transfer to and manufacturing at CDMOs, and deliver robust drug product supply for clinical trials and launch/commercialization. • Reporting to the Vice President, Formulation and Drug Product Development, this role requires significant expertise in protein drug product process development, aseptic manufacturing, formulation development, quality and regulatory compliance, and ability to collaborate with cross-functional teams and external partners to deliver on drug product supply.

Requirements

• Minimum of 12 years industry experience in drug product development and manufacturing • PhD in relevant discipline (eg, chemical engineering, biochemical engineering, chemistry or related field) or commensurate years of education and experience • Experience in biologics drug product process development and aseptic manufacturing required • Experience managing drug product CDMOs including tech transfers and oversight of GMP manufacturing operations • Proven track record of advancing assets from pre-clinical through IND and into late phase development • Extensive experience with cGMPs and knowledge of regulatory guidance • Experience with formulation development of recombinant proteins, including antibodies • Experience with commercialization of biologics is preferred • Demonstrated ability to collaborate with cross-functional stakeholders such as drug substance development, analytical development, supply chain, device development, Quality, and Regulatory • Excellent communication skills with ability to clearly and concisely convey information to various stakeholders and cross-functional teams • Availability to participate in calls across multiple international time zones • Ability and willingness to travel up to 25%, including frequently to the Apogee lab in Boston

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