Associate Director, Formulation Development
Oruka Therapeutics • Waltham, MA3d • Hybrid
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Associate Director, Formulation Development, Tech Ops (Biologics)
Oruka Therapeutics•Waltham, MA
•Hybrid
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, particularly 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 clinical programs, BLA/MAA submissions, formulation changes, and commercial readiness across the US, Canada, and EU. This highly visible CMC role partners closely with CMC, Quality, Regulatory Affairs, Process Development, Manufacturing, analytical development, clinical teams, and external partners. The successful candidate will lead formulation strategy and late-stage deliverables, oversee CDMOs and contract laboratories, contribute to regulatory interactions and documentation, and build and mentor a high-performing formulation development team. The role requires up to 20% travel. The position may be hybrid or remote. Employees who are commutable to the Waltham, Massachusetts office are required to work onsite three days per week. The anticipated salary range is $182,000–$208,000, with a competitive base salary, equity, and an opportunity for a performance-related bonus.
Requirements
- Experience with monoclonal antibodies in both monotherapy and co-formulation is required.
- Experience with prefilled syringe and autoinjector selection studies is required.
- Master’s degree with at least 8 years of relevant experience, or PhD with at least 6 years of relevant experience, in a scientific discipline and formulation development and/or drug product development.
- Relevant industry experience in phase-appropriate formulation development and container closure selection studies.
- Experience with formulation robustness studies supporting process characterization/process performance qualification and commercialization.
- Experience with late-phase comparability studies, particularly those supporting commercialization.
- Experience authoring or contributing to regulatory filings, specifically Module 3 content for formulation development and stability studies.
- Demonstrated success transferring technology between CDMOs, with a focus on late-stage development and commercial launch.
- Experience with methods including U/HPLC, capillary electrophoresis, spectrophotometry, bioassays (ELISA and cell-based), and device functional testing.
- Excellent writing, organizational, 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.
- Ability to travel up to 20%.
Nice To Haves
- Experience supporting drug product process development studies.
Responsibilities
- Lead phase-appropriate biologics formulation development workflows, including selection, optimization, and robustness studies, with a focus on high-concentration products.
- Lead formulation development for co-formulation products.
- Conduct prefilled syringe and autoinjector selection studies and testing.
- Partner with drug product and clinical teams on container closure selections aligned with the QTPP and clinical needs.
- Design and execute in-use compatibility studies to support 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 teams on 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.
Benefits
- Competitive salary and benefits package.
- Equity.
- Performance-related bonus opportunity.
- Opportunities for professional growth and development.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
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