Vice President - Formulation and Drug Product Development

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Apogee Therapeutics

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Apogee Therapeutics, LLC is a biotechnology company advancing novel, potentially best-in-class therapies to address the needs of the millions of people living with immunological and inflammatory disorders.

Immunology & Inflammation

51 - 200

💰 $149M Series B on 2022-12

Description

•We are seeking a dynamic and experienced Vice President of Formulations and Drug Product Development to lead development and ensure robust drug product supply for launch/commercialization. •Reporting to the SVP, Development, Manufacturing, & Supply, this pivotal role demands a senior leader with extensive expertise in formulation science, drug product manufacturing, regulatory compliance, and a proven track record in guiding clinical antibody candidates through development and into commercialization. •Define and execute Apogee's drug product strategy across the portfolio. •Develop comprehensive strategies to advance clinical assets from Phase 1 through launch and commercialization. •Develop clinical and commercial formulations for recombinant proteins, including antibodies. •Conduct risk assessment and establish phase-appropriate product understanding and control strategies using QbD framework. •Support manufacture of clinical GMP DP throughout product lifecycle, including tech transfer, campaign analysis, and risk assessments. •Review and approve batch records, support investigations, and resolve deviations. •Collaborate effectively with cross-functional teams, including analytical development, device, supply chain, quality assurance, and regulatory affairs. •Analyze process and manufacturing data to understand and optimize process performance. •Author and support regulatory submissions (IND, IMPD, amendments, IB, BLA, etc.). •Work closely with supply chain to support seamless clinical supply. •Liaise with device development to develop options and mitigate risks in transitioning between product configurations and novel delivery technology. •Guide the organization in optimizing business processes to support effective CMC management and communication. •Collaborate closely with colleagues to ensure a seamless, highly integrated TechOps team. •Author and review internal procedures, reports, and presentations.

Requirements

•PhD in relevant discipline (e.g., chemistry, biochemical engineering, or relevant field) or commensurate years of education and experience. •Minimum of 20 years of industry experience in formulations and drug product development and manufacturing. •Substantial experience leading drug product tech transfer to CDMOs and supporting DP campaigns with vials, syringes, and autoinjectors. •Proven success in late phase development and commercialization of biologics required. •Demonstrated ability to collaborate strategically and tactically with device, clinical development/operations, supply chain, analytical development, QA, and Regulatory. •Excellent communication skills with an ability to present to a variety of stakeholders and tailor message accordingly. •Strategic thinker with the ability to drive decision-making and problem-solving in a fast-paced environment. •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.