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Sr. Manager, Formulation and Drug Product Development

Lexington, MA

Kiniksa Pharmaceuticals is a commercial‑stage biopharmaceutical company developing and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications. With deep expertise in immunology and inflammation, Kiniksa is advancing a growing portfolio of approved and investigational medicines, anchored by its lead product, ARCALYST®, the first and only FDA‑approved therapy for recurrent pericarditis. Grounded in rigorous science and bold innovation, the company fosters a highly collaborative, patient‑first culture led by accomplished life sciences leaders. At Kiniksa, talented individuals are trusted and empowered to make a real impact—shaping the future of medicine while improving the lives of patients who need it most.

 

Kiniksa is seeking a highly motivated Senior Manager, Formulation and Drug Product Development, to join our Drug Product Development team in Lexington, MA.  Reporting to the Director, Formulation and Drug Product Development, this individual will drive CMC development activities and manage cross-functional projects. This position offers opportunities to make significant contributions to Kiniksa’s drug product development and pipeline programs.

This role is based in our Lexington, MA office. Our office-based employees follow a hybrid schedule of 4 days in the office, and 1 day remote.

Responsibilities (including, but not limited to):

  • Lead product candidates’ manufacturability/developability assessment and collaborate with Discovery team on drug candidate selection
  • Establish formulation screening strategies for high concentration biologics in a dynamic environment
  • Develop, manage, execute, and support clinical in-use studies and other dose administration related studies to support tox and clinical studies.
  • Contribute to the evaluation and selection of CRO and CDMO for development studies and GMP manufacturing
  • Manage external partners (CRO/CDMO) to advance project milestones
  • Support process development studies and DP manufacturing tech transfer
  • Author and review study protocols and reports, summarize and communicate project updates to stakeholders

Qualifications:

  • PhD or MSc with 4+ years of experience in protein chemistry and formulation science, particularly involving parenteral formulations.
  • Previous experience with biologics (such as monoclonal antibody, fusion protein, antibody drug conjugates) required
  • Strong problem-solving skills and excellent communication abilities
  • Ability to manage multiple priorities and work with ambiguity
  • Strong commitment to compliance and ethical standards
  • Ability to travel up to 5%

Compensation decisions are based on objective criteria including role responsibilities, experience/qualifications, internal equity, geographic location, and external market benchmarks.

Pay Range

$174,000 - $191,000 USD

Kiniksa is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status, or any other legally protected category. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. 

Kiniksa does not accept unsolicited resumes from staffing agencies or search firms. Any resumes submitted without a signed agreement will be considered property of Kiniksa, and no fees will be paid.

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