Associate Director, Formulation Development, Tech Ops (Biologics)
About The Position
Oruka Therapeutics is seeking an Associate Director of Formulation Development to provide scientific and strategic leadership for early- and late-stage formulation development of biologic drug products, including monoclonal antibodies, bispecific formats, and co-formulations. The role leads formulation development and container closure selection, and partners with the Drug Product team on process development studies. It supports BLA/MAA submissions, formulation changes, and commercial readiness while collaborating with CMC, Quality, Regulatory Affairs, and external partners. This hands-on leadership role supports formulation activities across multiple programs, from clinical trials through preparation for commercialization in the US, Canada, and EU. The Associate Director will build and lead a high-performing formulation development team, set technical direction and priorities, oversee CDMOs and contract laboratories, and review and approve development and regulatory documentation. The role requires up to 20% travel. The position is hybrid or remote; employees commuting to the Waltham, Massachusetts office are required to work onsite three days per week.
Requirements
- Master’s degree with 8 or more years of relevant experience, or Ph.D. with 6 or more years, in a scientific discipline and relevant formulation development and/or drug product development experience.
- Experience with monoclonal antibodies, including both monotherapy and co-formulation.
- Experience with prefilled syringe and autoinjector selection studies.
- Industry experience in phase-appropriate formulation development and container closure selection studies.
- Experience with formulation robustness studies in support of PC/PPQ and commercialization.
- Experience with late-phase comparability studies, particularly those supporting commercialization.
- Experience authoring or contributing to regulatory filings, specifically Module 3 sections for formulation development and stability studies.
- A track record of successful technology transfers between CDMOs, with a focus on late-stage development and commercial launch.
- Excellent writing, organization, communication, and people management skills, with the ability to work effectively with diverse internal and external stakeholders.
- Creative and strategic mindset and ability to work in a fast-paced environment.
Nice To Haves
- Experience supporting drug product process development studies.
- Experience with methods including U/HPLC, capillary electrophoresis, spectrophotometry, ELISA and cell-based bioassays, and device functional testing.
Responsibilities
- Lead phase-appropriate biologics formulation development workflows, including selection, optimization, robustness studies, and high-concentration product development.
- Lead formulation development and container closure selection in partnership with drug product and clinical teams, aligning selections with QTPP and clinical needs.
- Design and execute in-use compatibility studies for subcutaneous administration of high-concentration biologics.
- Partner with analytical development to verify that formulation changes do not affect assays.
- Develop formulation strategies for robustness and comparability studies, BLA/MAA submissions, and post-approval changes.
- Partner with Process Development, Manufacturing, Quality, and Regulatory to support late-stage development, technology transfer, and commercial launch readiness.
- Support formulation risk assessments, control strategy development, and lifecycle management.
- Serve as formulation lead for regulatory interactions, including agency questions and inspections.
- Build, mentor, and lead an internal and/or external formulation development team.
- Set technical direction, priorities, and timelines for late-stage formulation deliverables.
- Manage and provide technical oversight to CDMOs and contract laboratories.
- Review and approve formulation development protocols, development reports, and regulatory documentation.
- Travel up to 20%.
Benefits
- Competitive salary and benefits package.
- Equity.
- Performance-related bonus opportunity.
- Opportunities for professional growth and development.
- Supportive and inclusive team environment.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
