Vice President, Formulation and Drug Product Development
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.
Key Responsibilities
- 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
Ideal Candidate
- 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
The anticipated salary range for candidates for this role will be $310,000-$350,000/ year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.
- 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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