MANAGER, QUALITY CONTROL STABILITY
6 month renewable contract
The Manager, Quality Control Stability will be responsible for all aspects of Stability management for drug substances, drug substance intermediates and drug products. This individual will establish and update tables of data for all materials for tracking and trending stability.
The Manager, Quality Control Stability demonstrates knowledgeable understanding of executing QC test methods, generating associated data packages, auditing data generated by others and managing the QC laboratory schedule on a day to day basis.
Must have strong leadership abilities and communication and interpersonal skills. Responsible for meeting deadlines, demonstrates effective use of time, and handles multiple assignments simultaneously. Capable of strategic thinking and proposing innovative solutions to drug substance, drug substance intermediate and drug product stability management. Must be capable of collaborating in a team environment. Should be able to influence through effective communication and be flexible and responsive to changes in priorities and planning.
S/he will aid in the development of Quality Control strategy for the Lexington site. S/he will assist in building and maintaining strong working relationships with technical internal and external. Formulates and meets quality control objectives. Sets priorities to ensure quality and timelines are met to ensure material and products are tested, reviewed and approved within the accepted time frames. Interprets data and resolves technical issues.
- Provide internal stability tracking and trending for drug substance, drug substance intermediate and drug product using software appropriate to stability and expiry extension.
- Provide oversight of stability studies at external vendors and reviews data.
- Familiarity with a full range of analytical techniques, review and evaluate raw data from all analytical methods (UPLC, qPCR, ELISA, NTA and DLS).
- Leads laboratory deviations and investigations (IA, OOS, OOT) and provides investigation closure.
- Author stability protocols and reports.
- Lead and participate in providing the necessary information for regulatory filings and inspections.
- Lead and support CAPA/Continuous Improvement Initiatives.
- Participate in the development and revision of product specifications; provide scientific input and statistical analysis of results.
- Analyze stability studies for tracking and trending quality attributes.
- Develops and executes continuous improvement initiatives to ensure the QC organization meets key performance indicator goals
- Coordinate stability pulls from all internal stability studies, manage sample shipments to and from storage and testing sites, monitor and review data received from external sites.
- Manage the QC laboratory testing schedule.
- Resolve technical problems through scientific understanding, options assessment, and application of innovative solutions.
- Generate complete, accurate, and concise laboratory documentation.
- Comply with safety guidelines, cGMPs and other applicable regulatory requirements.
- Background in Quality Control Laboratory environment and Laboratory Operations.
- Strong knowledge of cGMP/ICH/FDA/EU regulations.
- Strong analytical, communication, presentation, and writing skills.
- Able to interpret data
- Perform assigned, complex and/or varied tasks
- Ability to plan, organize and execute on stability studies, and manage multiple projects simultaneously.
- Ability to work cross-functionally in a fast-paced team environment.
- Proven track record of being personable, energetic, responsive, empowering, inclusive, action-oriented, accountable, and an effective communicator.
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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