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Director, Drug Product Development

Remote

 

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 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.

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

Key Responsibilities 

  • Define and develop robust biologics drug product processes across the portfolio
  • Oversee drug product manufacturing including 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 as required, and late-phase commercial readiness
  • Collaborate with drug product development and device teams to develop drug product presentations in vial, pre-filled syringe, and/or autoinjector
  • Perform risk assessments using a QbD approach to define drug product process development and manufacturing strategies
  • Trend manufacturing data and identify opportunities for process improvement and optimization
  • Support formulation development and optimization for high concentration, injectability, compatibility, and shelf-life throughout product development lifecycle
  • Collaborate to develop and optimize biologics co-formulations and drug product presentations
  • Collaborate with Quality team and external partners to review and approve batch records, support investigations, and resolve deviations
  • Communicate findings and progress through presentations and reports
  • Support authoring of regulatory submissions (IND, IMPD, BLA, briefing books, etc.)

 Ideal Candidate 

  • 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

The anticipated salary range for candidates for this role will be $200K - $225K/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
  • 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
 
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.
 
To review our privacy policy, click here

 

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