Director, Formulation and Drug Product Development

Apogee Therapeutics; United States; Remote; USD 210,000 - 235,000; Full time

Job summary

Apogee Therapeutics is seeking a Director for Formulation and Drug Product Development. The successful candidate will play a crucial role in developing innovative protein drug products and managing processes from clinical trials to commercialization. This position requires strong expertise in formulation and aseptic manufacturing processes. Join a pioneering biotechnology company dedicated to improving patient outcomes through advanced therapies.

Benefits

Market competitive compensation

Performance bonus

Flexible PTO

Two company-wide shutdowns each year

Commitment to professional growth

Qualifications

• Minimum 12 years industry experience in drug product development
• Experience with formulation development of recombinant proteins
• Knowledge of regulatory guidance and cGMPs

Responsibilities

• Support drug product and formulation development strategies
• Define and develop manufacturing processes for biologics
• Analyze stability data to evaluate formulations

Skills

Collaboration

Aseptic manufacturing

Risk assessment

Analytical thinking

Process improvement

Communication

Education

PhD in relevant discipline

Job description

Director, Formulation and 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 companyseeking 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, Formulation and 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 development including formulation development, process development, aseptic manufacturing including pre-filled syringes, support of clinical studies, quality and regulatory compliance, and ability to collaborate with cross-functional teams and external partners.

Embedded in the Formulation and Drug Product Development 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

• Support drug product and formulation development strategies to advance clinical assets from Phase 1 through launch and commercialization
• Define and develop robust biologics drug product manufacturing processes across the portfolio
• Collaborate with drug product development and device teams to develop drug product presentations in vial, pre-filled syringe, autoinjector, and advanced delivery technologies.
• Develop formulations and co-formulations for protein therapeutics, including antibodies
• Support clinical studies through clinical dose preparation development, design and oversight of clinical in-use stability studies, and collaborate with cross-functional teams to prepare clinical study documentation such as Pharmacy Manuals and Investigator Brochures
• 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 validation, and commercial readiness
• Perform risk assessments using a QbD approach to define drug product process development and manufacturing strategies
• Analyze and trend stability data to evaluate formulations and product shelf-life
• Analyze manufacturing data and identify opportunities for process improvement and optimization
• 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 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
• Significant experience with formulation development of recombinant proteins, including antibodies
• Significant experience in biologics drug product process development and aseptic manufacturing
• Experience with prefilled syringe dosage forms and combination products
• Experience managing drug product CDMOs including tech transfers and oversight of GMP manufacturing operations
• Track record of advancing assets from pre-clinical through IND and into late phase development
• Experience with process validation and commercialization of biologics is preferred
• Experience with clinical study support including clinical dose preparation, clinical in-use studies, and support of Pharmacy Manual and/or Investigator’s brochures preferred
• Extensive experience with cGMPs and knowledge of regulatory guidance
• 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
• 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 $210,000 – $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
• 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 Opportunityemployer. 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.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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Formulation development of recombinant proteins, including antibodies

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Process validation and commercialization of biologics

Clinical study support including clinical dose preparation, clinical in-use studies

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