What are the responsibilities and job description for the CMC Internal Operations Specialist position at Kiniksa Pharmaceuticals?
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 individual will lead/support various cross-functional internal lab operation activities for process development and pilot scale clinical manufacturing for products within the Kiniksa pipeline. In addition, the individual will support internal supply chain (shipping & receiving), materials management, facilities and EHS lab needs. Individual will also work cross functionally across several internal Kiniksa groups to help with strategy development. The candidate is preferred to have experience with single use raw materials and possess a general understanding of compliance for early stage clinical production. The candidate must be highly motivated, science driven, and results oriented in a team environment.
Responsibilities (include But Not Limited To)
Pay Range
$69,500 - $76,500 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.
The individual will lead/support various cross-functional internal lab operation activities for process development and pilot scale clinical manufacturing for products within the Kiniksa pipeline. In addition, the individual will support internal supply chain (shipping & receiving), materials management, facilities and EHS lab needs. Individual will also work cross functionally across several internal Kiniksa groups to help with strategy development. The candidate is preferred to have experience with single use raw materials and possess a general understanding of compliance for early stage clinical production. The candidate must be highly motivated, science driven, and results oriented in a team environment.
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
- 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
- Preferred experience in a GMP regulated environment and good documentation practices
- Fundamentals in solution preparation (0-200L scale)
- Basic knowledge of various raw materials for use in bio-processing
- 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
- Title and level will be determined by education and experience
Pay Range
$69,500 - $76,500 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.
Salary : $69,500 - $76,500