Principal Scientist, Formulation Development (Onsite/Boston)

 

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 Principal Scientist, Formulation Development to develop advanced, protein formulations and drug delivery presentations to support progression of pipeline candidates across Apogee’s drug product portfolio. Reporting to the Vice President, Formulation and Drug Product Development, this role requires significant expertise in protein formulation development throughout the product lifecycle to develop advanced formulations, co-formulations, and evaluate innovative formulation and drug delivery technologies to support product lifecycle initiatives. 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 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, including Person-in-Plant as needed
• Develop strategies for biologics co-formulation development, characterization, and optimization
• Collaborate with drug product development and device teams to develop drug product presentations in vial, pre-filled syringe, and/or autoinjector
• Develop formulation strategies to support developability assessments and pre-clinical to IND readiness
• Design and support clinical in-use studies to supply clinical trial plans
• Collaborate with analytical development teams to evaluate physicochemical properties, product degradation, and stability-indicating attributes
• Support phase-appropriate strategies for drug product development, process transfer and scale-up as required, and late-phase commercial readiness
• Evaluate complex formulations, such as novel high concentration technologies including emulsion- and particle-based approaches, and extended or sustained release technologies to support drug delivery lifecycle opportunities
• Perform risk assessments using a QbD approach to define drug product development and manufacturing strategies
• Support oversight of drug product development and manufacturing CDMOs and external contract testing laboratories
• Communicate findings and progress through presentations and reports
• Support authoring of regulatory submissions (IND, IMPD, BLA, briefing books, etc.)

Ideal Candidate 

• Minimum of 7 years industry experience in formulation development
• PhD in relevant discipline (eg, chemistry, chemical engineering, biochemical engineering, or related field) or commensurate years of education and experience
• Extensive experience in formulation development of recombinant proteins, including antibodies
• Co-formulation experience preferred. Complex formulation experience such as novel high concentration or sustained release technologies preferred.
• Demonstrated ability to collaborate with cross-functional stakeholders including 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
• Knowledge of cGMPs and regulatory guidance
• Availability to participate in calls across multiple international time zones