The Manager, Quality Control will be responsible for day-to-day oversight of analytical testing at contract laboratories and contract manufacturing facilities including method transfer, qualification, and validation, critical materials management, assay life cycle management, and data review. This role will interact with internal, multidisciplinary teams to ensure successful delivery of results.This role will also provide QC support for establishment and operations of an internal CMC lab and cGMP manufacturing facility.
This is an exciting opportunity for the right individual to join the Kiniksa team at a time when significant growth is occurring and the development of a scalable quality unit is key.
- Manage coordination of Kiniksa samples at external testing laboratories for testing, including sample and shipping information, as necessary.
- Monitor contract laboratory activities to ensure compliance and timeliness of certificates of analysis and reports.
- Review QC data and participate in batch release.
- Oversee and manage Kiniksa stability programs for drug substance, drug product, and any other relevant products including:
- Stability lot selection (e.g. clinical, process validation, pivotal lots, registration, annual commitments).
- Generation of study protocols and approvals.
- Selecting temperature conditions and appropriate time-points.
- Generation, review, and approval of stability interim and final study report(s).
- Data review and trending.
- Support current shelf life of Kiniksa products as well as extension of shelf-life based on stability data and trends.
- Manage real-time trending of stability data to identify and actively manage Out of Trends (OOTs) and Out-of-Specification (OOS) investigations for lots on stability.
- Assist in the management of quality systems including temperature excursions, Deviations/NCRs, Change Controls, CAPAs, and Quality Investigations.
- Support Kiniksa regulatory filings, submissions, and annual product reviews by overseeing compilation of accurate real-time stability data and tables.
- Author, review, and approve various quality documents associated with Kiniksa products.
Education and Experience:
- BS in a scientific area with 10+ years experience in Quality Control.
- Knowledge of analytical testing concepts and current cGMPs including laboratory controls and good documentation practices.
- Demonstrated experience in analytical methodologies common for biologics analysis including SEC-HPLC, IEF, CE-SDS, ELISA, 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.
- Experience in preparing and defending regulatory filings.
- Ability to work a flexible work schedule to accommodate program priorities, international activities, and travel as needed.
- Previous experience with data trending and statistical programs (JMP, MiniTab, Excel, etc.) preferred.
- Self-motivated, assertive, and self-confident with the ability to act with urgency and passion.
- Flexible and adaptable to changing and evolving priorities and needs.
- Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company.
- Strong technical/analytical skills to identify and solve problems.
- Proven ability to work with a high level of integrity, accuracy, and attention to detail.
- Ability to make thoughtful, integrated, timely and meaningful decisions and take corresponding actions.
- Resourceful, collaborative, creative, enthusiastic, and results-oriented.