Lead the day-to-day operations of QC's commercial testing programs, including microbiology, ME, stability, and raw material and drug substance testing.
Deliver timely and compliant test results and support deviation resolution in a Lean and continuous improvement manner.
Oversee the performance management, selection, mentoring, and development of QC laboratory staff.
Ensure GMP compliance and support the transfer, validation, and implementation of laboratory systems.
Collaborate with cross-functional teams to support internal testing and testing at contract manufacturing organizations (CMOs) or contract laboratories.
Provide support for internal and external health authority audits and inspections. Work with the digital/IT and QC teams to strengthen data integrity and digital systems in the laboratories.
Contribute to budget planning and resource allocation within QC. Participate in stability program testing, APQR data support and test troubleshooting.
Define clear objectives and key performance indicators (KPIs) for the QC team, while developing assistants and succession plans.
Foster an inclusive work culture focused on high performance, innovation, and learning.
Support the development and continuous improvement of SOPs, training programs, and documentation systems.
Lead and support laboratory investigations, controlled changes, and CAPAs. Oversee the monitoring, trending, and analysis of QC data (including method and product performance).
Collaborate on improving the laboratory's IT/QC systems in accordance with evolving GMP standards.
Provide analytical data for regulatory filings and study support.
Support Moderna's mission by assuming additional responsibilities as required by the business.
Qualifications
Education: Bachelor of Science in a relevant discipline. Experience: Minimum of 8 years in industry with 4 to 6 years in management or supervision. Certifications/Training: General laboratory operations, method acquisition and qualification.
Technical writing skills.
Proficiency in Microsoft Office programs.
Familiarity with electronic databases (e.g., LIMS, SAP, LMS).
Knowledge of QC operations including bioassays, chemistry, and microbiology.
Experience with HPLC instruments/software.
Strong written and oral communication and organizational skills.
Knowledge of industry standards and guidelines, experience supporting compliance audits.
Demonstrated ability to work effectively within established guidelines.
Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
Working knowledge of current FDA, EU, and ICH guidelines and regulations.
Ability to prioritize and successfully complete multiple projects in a fast-paced environment.
Desire to make a difference in a fast-growing company focused on transformation, boldness, curiosity, and collaboration.
