Kiniksa Pharmaceutical Lexington , MA 02421
Posted 4 days ago
Reporting to the Executive Director, Quality Control the Manager, Quality Control Operations will be responsible for day-to-day oversight of routine batch testing at contract and internal Kiniksa testing laboratories. Role 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 in the office, and 1 day remote.
Responsibilities (including, but not limited to):
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
Assure availability of critical reagents and other essential materials
Manage GMP reserve sample program
Drive improvements and ensure inspection readiness for area of responsibility
Manage SOW and contracts for areas of responsibility
Qualifications:
6+ 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 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
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 Pharmaceutical