Scientist II, Quality Control Analytical
On-site · Portsmouth, New Hampshire, United States
Job Summary
Lead and execute analytical method transfer programs from initiation to completion, ensuring on-time execution and adherence to program requirements and manufacturing readiness timelines. Develop, implement and lead the transfer of analytical methods, including method verification, qualification and validation activities aligned with program requirements and business objectives. Identify potential challenges and risks associated with method transfers and develop mitigation strategies to ensure successful on-time completion. Participate in cross-functional teams as a Quality Control subject matter expert and technical resource responsible for providing quality control oversight and support to Validation and Tech Transfer manufacturing operations internally or at contracted suppliers. Execute analytical testing as required to support on-time product release and in adherence with cGMP and company procedures. Review testing and laboratory records for accuracy and compliance with cGMP and procedures. Author, review, and/or approve SOPs, method transfer and validation plans, protocols, reports, specifications, and justification of specifications. Oversee analytical and QC activities for site and Contract Testing Laboratories. Identify, alert, and propose solutions to issues on instruments and test executions. Perform data review and trend analysis to support all areas of laboratory operation. Identify, facilitate, and/or lead continuous improvement efforts. Perform and lead investigations for out-of-specification and out-of-trending data as per cGMP standards. Support on-the-job training for junior QC personnel, review and escalate to management as needed. Manage and Maintain an adequate inventory of supplies needed for all analytical testing requirements.
Required Qualifications
- Bachelor’s degree in Chemistry, Biochemistry, Biotechnology, or Molecular Biology
- 10 years of progressive, post-baccalaureate experience in the job offered or related occupation implementing equipment and test methods (Spectrophotometry, Appearance testing, and chromatographic methods) in a cGMP laboratory
- experience supporting regulatory filings (e.g., US, EU, USP) and participating in method transfers
- ability to lead analytical method transfer programs, develop/validate methods, perform data review and trend analysis
- experience authoring/reviewing SOPs, method transfer and validation plans, protocols, reports, and specifications
- ability to identify risks and mitigate issues to ensure on-time completion
- experience providing quality control oversight and support to Validation and Tech Transfer operations
- training and mentoring junior QC personnel
- inventory management of analytical supplies
- strong collaboration with cross-functional teams
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