CMC Internal Operations Specialist

The Internal CMC Operations Specialist, reporting to the Director, Internal Lab Operations 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. The hours for this role are 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.

This role is based in our Lexington, MA office and requires employees to be onsite five days per week

Responsibilities (include but not limited to): 

• 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 and collaborates with CMC, Quality, Supply Chain, and Clinical teams to ensure alignment on manufacturing and launch activities
• Clear operational communication by effectively communicating timelines, risks, and inventory status to stakeholders
• Patient-impact awareness – understands how operational execution directly supports timely delivery of therapies to patients
• Strong mathematical aptitude - performs solution preparation and calculations with confidence and precision
• Formulation support skills - assists with preparing solutions and handling materials based on established protocols

Standout Skills for Impact:

• Operates within regulated environments, adhering to quality and documentation standards
• Anticipates supply or process gaps and takes initiative to resolve them
• Plays a direct role in enabling delivery of clinical-stage therapies
• Performs solution preparation and calculations with confidence and precision
• Supports processes that ensure safe, high-quality clinical materials
• Motivated by the impact of delivering medicines to patients in need

Qualifications and Experience:

• BS/BA degree + 0-3 years’ experience in the Biotech Industry (preferred)
• Relevant biological process development and manufacturing experience with a strong record of achievement
• Mathematical aptitude in solution preparation (0-200L scale)
• Highly flexible, works well in a team environment, and has the skills necessary to organize, communicate and influence, with an unquestionable level of integrity
• Demonstrated proficiency in oral and written communication, an innovative problem solver and proven ability to recognize and recommend areas for improvement
• Ability to deliver objectives on time in pressurized, fast-paced environment, whilst also meeting all compliance, quality and cost targets
• Preferred experience in a GMP regulated environment and good documentation practices.

Physical Requirements:
Prolonged standing/sitting 
Ability to lift a minimum of 25 pounds
Carry boxes/ supplies for several minutes at a time
Operation of pallet jack and hand dollies
Bending/Kneeling
Pushing/Pulling of large objects
Reaching/Twisting