CMC Internal Operations Specialist 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.

The Internal CMC Operations Specialist will play a critical role in supporting Kiniksa’s ambitious pipeline, including the execution of Phase 1 GMP clinical product manufacturing and launch activities. This role is essential to ensuring that high‑quality medicines are produced and ultimately delivered to patients in need making it one of the closest operational roles to patient impact within the organization. Candidates should be highly detail‑oriented and possess strong mathematical aptitude, with comfort performing solution preparation utilizing formulations, as well as a raw material inventory, shipping & receiving and lab maintenance support activities.

The successful candidate will be required to complete EHS and Wastewater Management certifications, including online DOT/IATA training and an 8‑week (one day per week) Wastewater Management course held during work hours. Kiniksa will fully sponsor this training, with the expectation that the candidate will successfully obtain certification, pass state regulated license exam and independently perform daily wastewater monitoring thereafter as required by law.

This position is based on site in Lexington, MA and requires five days per week onsite during standard business hours (8:00 AM – 4:00 PM) to support hands‑on lab and operational activities. There may be occasions when this individual is required to work outside standard hours, including weekends, holidays, or other off‑hours, to support ongoing activities or respond to alarms.

• Support material management for clinical production including shipping & receiving, procurement, SAP goods receipt, inventory, and kitting activities
• Assist with facilities & EHS activities including work orders, maintenance documentation review and upload to CMMS, hazard waste compliance and daily/monthly/weekly inspections
• Support internal supply chain activities for all lab teams by performing pack outs, coordinating shipments, and completing any necessary documentation
• Perform small and large scale (0‑200L) solution production, including authoring and executing associated form preps
• Support upstream and downstream process development and manufacturing operations (GMP & non‑GMP) for multiple programs spanning all phases of biopharmaceutical development, as required
• Interact effectively and transparently with all Kiniksa team members and stakeholders
• Debottleneck and rationalize operation processes to optimize process consistency and efficiency

• Cross‑functional operational partnership – collaborates with CMC, Quality, Supply Chain, and Clinical teams to ensure alignment on manufacturing and launch activities
• Clear operational communication – effectively communicates timelines, risks, and inventory status to stakeholders
• Patient‑impact awareness – understands how operational execution directly supports timely delivery of therapies to patients
• GMP manufacturing support – contributes to execution of Phase‑1 clinical product manufacturing activities with precision
• Operational agility – adapts to changing program demands, timelines, and priorities in a clinical‑stage environment
• Hands‑on lab & operations support – executes shipping/receiving, inventory management, and lab maintenance tasks efficiently

• Detail‑oriented execution - ensures accuracy across formulations, materials handling, and…