This role manages the sample receipt and Reference Standard Program of Release and Stability Laboratory department supporting validation, testing and reporting of in-process, release and stability samples. Specific assigned persons are responsible for the supervision of other RSL personnel, optimizing Department resource allocation according to project/program needs to assure testing activities occur in an efficient and cGMP compliant manner while fostering the Vertex vision and values.
- Coordinate the receipt of all incoming samples for the laboratory to ensure samples available for testing in a timely manner.
- Manage the Reference Standard Program which supports all projects from First in Human through Phase II
- Prioritizes resources appropriately to meet all commitments.
- Ensure direct report lab personnel have adequate training, education, and experience to perform their GMP related job function effectively.
- Provides guidance to direct reports when issues arise
- Monitor, track and publish incoming samples and reference standard program metrics
- Provides developmental feedback and coaching to direct reports to create a collaborative environment that attracts, develop and retains personnel.
- Authors and reviews data, SOPs, analytical methods, protocols and reports.
- May author OOS/OOT investigations and laboratory deviations.
- Proactively pursues continual improvement opportunities to increase value and efficiency.
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
- A minimum of a Bachelor Degree in science or related discipline is required.
- 7+ years of experience in pharmaceutical/biopharmaceutical industry with 2+ years of supervisory responsibility.
- Knowledge of US and EU cGMP regulations/guidance and some experience with regulatory agency inspections.
- General knowledge of analytical methodologies such as chromatography, dissolution, and Karl Fisher.
- Strong attention to detail.
- Effective communication skills, both verbal and written.
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