Director, Drug Product Development

About Apogee Therapeutics

Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally.

Apogee Therapeutics, Inc. is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need. Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.”

We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.

If this sounds like you, keep reading!

Role Summary

We are seeking a Director, 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 VP of Formulation and Drug Product Development, this position requires deep expertise in process development, aseptic manufacturing for prefilled syringes (PFS), combination product development, and compliance, while fostering collaboration across teams and external partners. This person will be a subject matter expert in drug product manufacturing, including PFS, within the CMC organization, providing strategic guidance and technical leadership across cross-functional teams.

Embedded in the Formulation and Drug Product Development team, this position will be a member of an integrated Development, Manufacturing & Supply team, and will collaborate closely with team members involved in drug substance development, device development, analytical development, and supply chain.

Key Responsibilities

• Serve as a subject matter expert in PFS process development and manufacturing, providing technical guidance and strategic insights to cross-functional teams

• Develop late-phase and commercial launch strategy for PFS development and manufacturing

• Oversee drug product tech transfer, process development, and GMP manufacturing operations including person in plant support

• Manage drug product CDMO adherence to deliverables, timelines, and performance in collaboration with Quality and Tech Ops team members

• Support phase-appropriate strategies for drug product development, process transfer and scale-up, process characterization, process performance qualification (PPQ), and commercial readiness

• Perform risk assessments using a QbD approach to define drug product process development and manufacturing strategies

• Collaborate with drug product development and device teams to develop drug product presentations in vial, PFS, autoinjector, and advanced delivery technologies

• Analyze manufacturing data and identify opportunities for process improvement and optimization

• Support formulation and co-formulation development for protein therapeutics, including antibodies

• Collaborate with Quality team and external partners to review and approve batch records, support investigations, and resolve deviations

• Author and review regulatory submissions (IND, IMPD, BLA, briefing books, etc.)

Ideal Candidate

• Minimum of 10 years industry experience in drug product development and manufacturing

• 5+ years of experience in clinical and/or commercial Good Manufacturing Practice (GMP) operations for PFS drug products, ensuring regulatory compliance and operational excellence across all phases of manufacturing

• Demonstrated leadership in GMP manufacturing of combination products

• PhD in relevant discipline (e.g. chemical engineering, biochemical engineering, chemistry or related field) or commensurate years of education and experience

• Proven expertise in biologics drug product process development and aseptic manufacturing, preferably with a focus on monoclonal antibodies

• Experience managing drug product CDMOs including tech transfers and oversight of GMP manufacturing operations

• Experience with process performance qualification (PPQ) and commercialization of biologics

• Experience with pre-approval inspection (PAI) readiness and support is preferred

• Experience with drug product process extractables / leachables risk assessments is preferred

• Demonstrated ability to collaborate with cross-functional stakeholders such as drug substance development, analytical development, supply chain, device development, clinical development, clinical operations, 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 international time zones

• Position requires up to 25% travel including travel to domestic and international sites. In person attendance at Apogee All Hands meetings is required, typically held twice per year.

The anticipated salary range for candidates for this role will be $210,000 to $235,000 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.

What We Offer

• 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

• We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave

• 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

E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster.

Apogee Therapeutics is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

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