
location_on4, Hathaway Road, Lexington, Middlesex County, Massachusetts, 02420, United States
Kiniksa is a commercial-stage biopharmaceutical company dedicated to developing and commercializing novel therapies for diseases with unmet needs, with a specific focus on cardiovascular indications. Grounded in rigorous science and bold innovation, the company fosters a highly collaborative, patient-first culture led by accomplished life sciences leaders. 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.
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.
The Internal CMC Operations Specialist plays a critical role in supporting Kiniksa's ambitious pipeline, including the execution of Phase 1 GMP clinical product manufacturing and launch activities. This position is essential to ensuring that high-quality medicines are produced and ultimately delivered to patients, making it one of the closest operational roles to patient impact within the organization.
This role is based onsite in Lexington, MA, requiring five days per week during standard business hours (8:00 AM – 4:00 PM) to support hands-on lab and operational activities. While the core schedule is standard, there may be occasions requiring work outside these hours, including weekends, holidays, or off-hours, to support ongoing activities or respond to alarms. The successful candidate will be expected to complete EHS and Wastewater Management certifications, including online DOT/IATA training and an 8-week Wastewater Management course, with Kiniksa fully sponsoring the training and the expectation of independent daily monitoring thereafter.
Kiniksa is an Equal Opportunity employer and will consider applicants without regard to race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, disability status, or any other legally protected category. We 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.
Work model: On-site
4, Hathaway Road, Lexington, Middlesex County, Massachusetts, 02420, United States
Lexington, Massachusetts
BS/BA degree with 0-3 years' experience in the Biotech Industry. Experience in a GMP regulated environment and good documentation practices.
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