Associate Director, Formulation Development

About the role

We're looking for a Formulation Scientist on the CMC Development team to help us expand what's possible for patients with serious diseases. You'll lead drug product formulation development activities for biologics programs, including high-concentration formulations for mammalian- and bacterial-derived molecules. Additionally, you will provide technical leadership and mentorship to junior scientists, fostering a collaborative and high-performing team environment.

Responsibilities

• Design, develop, and optimize biologics drug product formulations, including aqueous and non-aqueous systems
• Develop high-concentration formulations to enable subcutaneous delivery and improved patient convenience
• Characterize and optimize excipient systems, buffer conditions, and stabilization strategies as well as evaluate physicochemical stability, aggregation, viscosity, and degradation pathways
• Conduct forced degradation and stress studies to understand product stability and define formulation design space
• Lead comprehensive analytical characterization of biologic molecules and formulations to inform formulation development as well as characterize higher-order structure, aggregation, particle formation, and colloidal behavior
• Investigate degradation pathways, structure–function relationships, and critical quality attributes and develop, qualify, and implement analytical methods to support formulation screening and optimization
• Provide technical leadership for formulation strategy, candidate selection, and developability assessments
• Support late-stage activities including comparability, stability strategy, and lifecycle management
• Author, review, and approve technical reports, protocols, and regulatory documentation (IND/IMPD/BLA)
• Lead and support technology transfer activities to internal manufacturing sites and CDMOs (from a formulation and characterization perspective)

Requirements

• You have a PhD with 2 years of experience or MS with 6 years of experience in formulation development.
• You are or you also have:
• Demonstrated experience in biologics drug product formulation development (aqueous and/or non-aqueous systems)
• Advanced analytical techniques (e.g., chromatography, spectroscopy, light scattering, calorimetry) to assess structure, stability, and interactions
• Strong expertise in analytical characterization techniques for biologics (e.g., SEC, DLS, DSC, spectroscopy methods)
• Strong understanding of protein stability, degradation mechanisms, and structure–property relationships
• Experience supporting early- and late-stage development programs

Qualifications

• Nice to have (but not required):
• Degree in Pharmaceutics, Chemistry, Chemical Engineering, Biochemistry, or related discipline
• Prior experience mentoring or leading junior scientists or technical staff
• Ability to operate effectively in a fast-paced, matrixed environment
• Hands-on experience with CDMOs and external development partners
• Familiarity with regulatory expectations and filings (IND, IMPD, BLA)
• Scientific and technical leadership in drug product formulation and characterization
• Strategic thinking across product lifecycle
• Quality mindset and regulatory awareness

Skills

• Proven experience in biologics formulation development
• Advanced analytical techniques for biologics
• Strong understanding of protein stability and degradation mechanisms
• Experience in formulation strategy and candidate selection
• Technical leadership and mentoring skills
• Knowledge of regulatory requirements and filings

Benefits

• Comprehensive medical, dental, and vision coverage and mental health support
• Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
• 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
• Employee Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
• Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back

Pay

$155,000.00 - $201,500.00 Annual