Senior Laboratory Manager, Chemistry Operations
3 weeks ago
The Senior Laboratory Manager, Chemistry Operations, is a critical leadership position responsible for overseeing the day-to-day activities of the QC Chemistry team at FUJIFILM Diosynth Biotechnologies. This role is accountable for ensuring GMP compliant laboratory operations, direct management and supervision of the QC Chemistry team, and technical subject matter expertise in Chemistry and Chromatography testing.
Job SummaryThe Senior Laboratory Manager, Chemistry Operations, will be responsible for managing the performance of the QC Chemistry team, ensuring timely delivery of results, and maintaining laboratory readiness for customer visits, audits, and regulatory inspections. This role requires strong leadership competencies, technical expertise, and excellent communication skills to represent QC Chemistry in cross-functional collaboration with stakeholders.
Responsibilities- Manage the daily activities of the QC Chemistry team to support DS and DP Manufacturing Process, testing of stability samples, method transfers of client methods, and change management
- Ensure overall performance of QC Chemistry team according to KPIs - assuring turn-around-times of all testing and supporting drug substance and drug product manufacturing production
- Oversee and manage laboratory exceptions and investigations and assure timely closure of cGMP KPI deliverables within the group
- Motivate the group to perform as efficiently as possible to reduce turn-around-times for testing and approval, ensure manufacturing is running and tech transfer activity timelines are met
- AUTHORS procedures, documents and reports, as needed, to support the QC Chemistry team and tech transfer activities
- Prioritize and focuses on optimized laboratory systems, including the use of IT systems (e.g. Labware)
- Identifies and implements needed procedural and/or policy changes in areas where needed
- Enforces established policies, processes and procedures and identifies areas where enhancements will improve daily work
- Represents QC Chemistry in cross-functional collaboration with QC Analytical Development, QC Program Management, Manufacturing, Process Science, and Quality Assurance stakeholders to achieve customer and FUJIFILM Diosynth Biotechnologies objectives
- AUTHORS, reviews, and approves data reports, out-of-specification (OOS) and out-of-trend (OOT) investigations, deviations, CAPAs, and Change Controls, as needed
- Ensures the team and laboratory maintain inspection readiness for customer visits, audits and regulatory inspections following cGMP guidelines and FUJIFILM Diosynth Biotechnologies processes
- Represents the QC Chemistry team during internal, customer and regulatory audits
- Ensures the timely delivery of results within deadlines by effectively managing the performance of the QC Chemistry team
- Executes managerial tasks per the FUJIFILM Diosynth Biotechnologies policies including coaching, guidance, and development of team members
- Manages complex problem solving, providing mitigation/outcome to management/team
- Supports management activities related to compliance with policies, appropriate personnel training, providing feedback for personnel development, and effective and timely decision making/corrective actions on the floor
- Bachelors degree with 8+ years of experience in a GMP environment OR Masters Degree with 6+ years of experience in GMP environment OR Ph.D. with 4+ years of experience in GMP environment
- 5+ years of experience with analytical testing, preferably raw material testing and release
- Previous QC Chemistry Management experience
- Masters degree or Ph.D. in Chemistry, Microbiology, Biological Sciences, Engineering or related science degree with 6+ years of GMP experience OR Ph.D. in Chemistry, Microbiology, Biological Sciences with 4+ years of GMP experience
- Previous experience with analytical testing, preferably raw material testing and release in the biopharmaceutical industry
- Experience with Microsoft Office, Smartsheet and laboratory LIMS and ERP systems (e.g., SAP)
Estimated Salary: $120,000 - $180,000 per year
This role is located in Holly Springs, North Carolina, United States, and offers a competitive salary and benefits package. FUJIFILM Diosynth Biotechnologies is an Equal Opportunity Employer and welcomes qualified applicants from diverse backgrounds.
Why Work with Us?
At FUJIFILM Diosynth Biotechnologies, we are committed to delivering high-quality biopharmaceutical products and services to our customers. Our team of highly skilled professionals works together to overcome complex challenges and drive innovation in the life sciences industry. As a Senior Laboratory Manager, Chemistry Operations, you will have the opportunity to make a meaningful impact on our business and contribute to the development of life-saving therapies.
How to Apply
To apply for this role, please submit your resume and a cover letter outlining your experience and qualifications. We thank all applicants for their interest; however, only those selected for an interview will be contacted.
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