Manager, Quality Control Operations

Reporting to the Associate Director, Quality Control Stability and Trending, the Manager, Quality Control Operations will be responsible for day-to-day oversight of routine batch testing at contract and internal Kiniksa testing laboratories. This individual will be responsible for sample management, data review, management of reference standards, critical reagents, certificate of analysis generation and delivery of QC results. This role will collaborate with internal/external, multidisciplinary teams and external partners.

This role is based in our Lexington office. Our office-based employees follow a hybrid schedule of 4 days (Monday - Thursday) in the office, and 1 day (Friday) remote.

Support Kiniksa’s Quality Control programs for commercial and late-stage clinical drug products, including combination products

Responsible for GMP reference standards including leading the qualification, requalification and inventory management across all laboratories

Participate on analytical teams to proactively support GMP routine operations

Coordinate shipping and sample management for all routine testing activities

Partner with contract testing labs to support routine release testing activities and ensure on time delivery of all batch testing including in-process, drug substance and drug product testing

Drive the timely completion of Quality System records associated with sample testing to improve reliability of test methods, facilitate change, and evaluate and prevent exceptions (change control, deviations, and CAPAs)

Author, review and approve related QC protocols, reports, and data.

Review and approve laboratory data and results, assuring their traceability and integrity

Generate Certificates of Analysis for product release, and other certificates of GMP testing

Coordinate testing of Kiniksa samples at intern/external testing laboratories

Review, approve stability data, protocols, and reports as needed

Assure availability of critical reagents and other essential materials

Manage GMP reserve sample program

Drive process improvements and ensure inspection readiness (ISO, GMP alignment) for area of responsibility

Manage SOW and contracts for areas of responsibility

Participate in budget, track KPI metrics and additional tasks as required.

5+ years experience in Quality Control in GMP setting. Experience in biologics required

BS in analytical chemistry, microbiology or related life sciences field

Experience in routine GMP QC operations including reference standard management and review/release of QC testing data

Knowledge of analytical methodologies common for biologics analysis in addition to compendial testing.

Proven ability to manage projects and work with cross-functional teams comprised of internal and/or external contacts, including CMOs

Demonstrated strong written and verbal communication skills

Proven mindset of proactive continuous improvement

Efficient independent worker with ability to focus and drive for results

Strong organizational skills and attention to detail

Ability to work in a fast paced-environment and to handle multiple tasks

Strong commitment to compliance and ethical standards

Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)

Ability to travel up to [5%]

Salary is commensurate with experience

Kiniksa Benefits Summary - USA

The expected salary range for Manager, Quality Control Oeprations is $129,000 - $144,000 annually. Compensation decisions are based on objective criteria including role responsibilities, experience/qualifications, internal equity, geographic location, and external market benchmarks.

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.