Principal Scientist, Formulation Development
2 months ago
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. We are 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.
Role Summary
We are seeking a Principal Scientist, Formulation Development to develop advanced protein formulations and drug delivery presentations to support the progression of pipeline candidates across Apogee’s drug product portfolio. This role requires significant expertise in protein formulation development throughout the product lifecycle.
Key Responsibilities
- Define and execute formulation development strategies across the portfolio
- Optimize formulations for high concentration, injectability, compatibility, and shelf-life throughout product development
- Support development and manufacturing campaigns as needed at CDMOs
- Develop strategies for biologics co-formulation development, characterization, and optimization
- Collaborate with drug product development and device teams
- Design and support clinical in-use studies
- Collaborate with analytical development teams
- Support phase-appropriate strategies for drug product development
- Evaluate complex formulations to support drug delivery lifecycle opportunities
- Perform risk assessments using a QbD approach
- Support oversight of drug product development and manufacturing CDMOs
- Communicate findings and progress through presentations and reports
- Support authoring of regulatory submissions
Ideal Candidate
- Minimum of 7 years industry experience in formulation development
- PhD in relevant discipline or commensurate years of education and experience
- Extensive experience in formulation development of recombinant proteins
- Co-formulation experience preferred
- Demonstrated ability to collaborate with cross-functional stakeholders
- Excellent communication skills
- Knowledge of cGMPs and regulatory guidance
- Availability to participate in calls across multiple international time zones
- This position is hybrid based in the Boston area
- Ability and willingness to travel up to 25%
The anticipated salary range for this role will be $165K - $185K/year. The final salary offered will depend on several factors.
What We Offer
- A great culture grounded in our C.O.R.E. values
- Opportunity to work in a fast-paced, highly dynamic environment
- Market competitive compensation and benefits package
- Flexible PTO
- Commitment to growing you professionally
E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify.
Apogee Therapeutics is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to any characteristic protected by law.
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