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  1. Home
  2. chevron_right
  3. healthcare & nursing
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  5. CMC Internal Operations Specialist
Kiniksa Pharmaceuticals logo

CMC Internal Operations Specialist

Not Disclosed•Full-TimeOn-site

location_on4, Hathaway Road, Lexington, Middlesex County, Massachusetts, 02420, United States

Apply Now

About Kiniksa Pharmaceuticals

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.

About the Role

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.

Equal Opportunity

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.

Application Note

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 location

Work model: On-site

location_on

4, Hathaway Road, Lexington, Middlesex County, Massachusetts, 02420, United States

Lexington, Massachusetts

Key Responsibilities

  • check_circlePerform small and large scale solution production including authoring and executing form preps
  • check_circleSupport upstream and downstream process development and manufacturing operations for multiple biopharmaceutical programs
  • check_circlePerform daily wastewater monitoring and maintain EHS certifications as required by law
  • check_circleDebottleneck and rationalize operation processes to optimize process consistency and efficiency
  • check_circleSupport material management for clinical production including shipping, receiving, procurement, and inventory activities
  • check_circleAssist with facilities and EHS activities including work orders, maintenance documentation, and hazard waste compliance
  • check_circleCoordinate pack outs and shipments for internal supply chain activities across all lab teams

Requirements

  • verifiedBS/BA degree
  • verified0-3 years' experience in the Biotech Industry
  • verifiedEHS and Wastewater Management certifications
  • verifiedDOT/IATA training
  • verifiedState regulated wastewater license exam
  • verifiedMathematical aptitude in solution preparation
  • verifiedExperience in a GMP regulated environment
  • verifiedGood documentation practices

Nice to Have

BS/BA degree with 0-3 years' experience in the Biotech Industry. Experience in a GMP regulated environment and good documentation practices.

Benefits & Perks

check_circleFully sponsored EHS and Wastewater Management certifications including DOT/IATA training
Kiniksa Pharmaceuticals logo
Company

Kiniksa Pharmaceuticals

Industry

healthcare & nursing

View company profilearrow_forwardlanguageWebsite
Quick Overview

Experience

0-3 yrs (Entry Level)

Job Type

Full-Time

Skills Required

Sap

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Frequently asked questions about CMC Internal Operations Specialist at Kiniksa Pharmaceuticals

What does a CMC Internal Operations Specialist at Kiniksa Pharmaceuticals do?expand_more
A CMC Internal Operations Specialist at Kiniksa Pharmaceuticals is responsible for the following: Perform small and large scale solution production including authoring and executing form preps; Support upstream and downstream process development and manufacturing operations for multiple biopharmaceutical programs; Perform daily wastewater monitoring and maintain EHS certifications as required by law; and Debottleneck and rationalize operation processes to optimize process consistency and efficiency.
What are the requirements for this CMC Internal Operations Specialist role?expand_more
To qualify for the CMC Internal Operations Specialist at Kiniksa Pharmaceuticals position, applicants should have: BS/BA degree; 0-3 years' experience in the Biotech Industry; EHS and Wastewater Management certifications; DOT/IATA training; State regulated wastewater license exam; and Mathematical aptitude in solution preparation.
Where is the CMC Internal Operations Specialist role at Kiniksa Pharmaceuticals located?expand_more
CMC Internal Operations Specialist at Kiniksa Pharmaceuticals is based in 4, Hathaway Road, Lexington, Middlesex County, Massachusetts, 02420, United States. This is a on-site role.
Is this CMC Internal Operations Specialist job remote, hybrid, or on-site?expand_more
Kiniksa Pharmaceuticals has listed this CMC Internal Operations Specialist role as on-site.
How much experience is required for this CMC Internal Operations Specialist role?expand_more
CMC Internal Operations Specialist at Kiniksa Pharmaceuticals typically requires 0–3 years of relevant experience at the entry level level.
What skills do you need for the CMC Internal Operations Specialist role at Kiniksa Pharmaceuticals?expand_more
Key skills for CMC Internal Operations Specialist at Kiniksa Pharmaceuticals include Sap; CMMS; GMP; Dot/iata; Wastewater Management; Biotech; Biopharmaceutical; and Upstream Process Development.
What category does the CMC Internal Operations Specialist role belong to?expand_more
CMC Internal Operations Specialist at Kiniksa Pharmaceuticals is part of the healthcare & nursing job category on Recrutus.
Recrutus

Curating the world's most innovative career opportunities. We bridge the gap between visionary talent and industry-leading companies.

Search roles by city, category, skill, or job type — explore verified US employers, salary benchmarks, and remote-friendly teams hiring nationwide.

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Recrutus helps candidates discover roles that match their skills and helps teams reach qualified applicants faster. Browse by metro, discipline, or work style — from internships to senior leadership.

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Terms of serviceCookie policyAcceptable useDMCA policyEmployer termsCandidate terms
CMMS
GMP
Dot/iata
Wastewater Management
Biotech
Biopharmaceutical
Upstream Process Development
Downstream Process Development
Solution Preparation
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