Principal Scientist, Formulation Development (Onsite/Boston)
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: C aring, O riginal, R esilient, and E goless.
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
This position is onsite based, in the Boston area 2-3 times weekly to foster collaboration with team members in our Boston-based laboratory / office in Boston’s Seaport district
Ability and willingness to travel up to 25% to external partner sites, and for company-wide or small team meetings
The anticipated salary range for candidates for this role will be $165K - $185K/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: C aring, O riginal, R esilient, and E goless
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
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