Responsible for planning and prioritizing GMP QC testing activities at Contract Manufacturing Operations (CMO) and contract testing laboratories. Serve/lead as Subject Matter Expert (SME) for analytical methods in support of clinical and commercial programs across the organization, particularly as it applies to method transfers and method validation activities. Serve as SME for Microbiology methods and procedures. Specifically, bioburden, endotoxin, microbial identification, environmental monitoring and sterility requirements. Serve/lead as stability SME. Design and implementation of cross program stability strategy. Manage stability studies.
- Organize and lead cross functional team meetings including technology transfer teams.
- Serve as SME for analytical methods, microbiological methods, and/or stability for global vaccines projects.
- Responsible for GMP release and stability testing of drug substances and drug product materials for global R&D and commercial programs, including development and implementation of stability programs and collaborative interactions with CMO/CTOs for scheduling and performance of testing.
- Responsible for the primary review and analyses of GMP test results, microbial control plans, preparation of interim and final stability reports, development of investigation protocols and reports, preparation of summaries and other documents for communication with regulatory agencies.
- Participate and, as applicable, make presentations in both internal and external reviews, including regulatory discussions.
- Responsible for planning, documenting and conducting investigations of test results and test method issues, co-management of GMP test method life cycle with Analytical Development, and assist with technical planning activities for process and product development and commercial strategies.
- Responsible for technical assessment of methods for compliance to GMP requirements, guidance documents, and analyses of critical quality attributes. Implement strategies for adding new GMP test methods and verify suitability for company materials.
- Assist with planning and execution of GMP sample management procedures, documenting transfers and facilitating material submission for release testing, stability studies and QA retains at CMO/CTOs.
- Manage critical reagent and reference material inventory. Support supplier audit, author quality agreements, CoA, and assist with batch disposition.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
PhD in microbiology, pharmaceutical science or closely related field with a minimum of 12 years of related experience in the pharmaceutical / biopharmaceutical industry or quality control environment. MS in microbiology, pharmaceutical science or closely related field with a minimum of 14 years of related experience in the pharmaceutical / biopharmaceutical industry or quality control environment. BS in microbiology, pharmaceutical science or closely related field with a minimum of 16 years of related experience in the pharmaceutical / biopharmaceutical industry or quality control environment.
- A thorough understanding of commercial QC laboratory processes is required and experience in an outsourced manufacturing and testing environment is preferred.
- A minimum of 4 years of leadership experience within a commercial GMP QC laboratory.
- Experience leading continuous improvement projects within QC laboratories.
- Experience with developing and implementing stability strategies and QC procedures and business processes.
- Knowledge of pharmaceutical cGMPs (US and EU) and CMC regulatory requirements, and strong technical expertise in microbiology and microbial methods and instrumentation, and statistical methods for data analyses.
- Excellent skills in written and verbal communication of detailed technical information and research strategies, effective interpersonal skills in coordination and organization of internal and external resources for materials testing, and skilled in analysis of data and application of statistical tools.
- Six Sigma Lean Laboratory, Greenbelt or Blackbelt Certification preferred
- Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
- Typical office and laboratory bending, stooping, lifting requirements apply.
- Lifting and moving supplies and equipment (up to 50 pounds).
- May require 10 15 % travel for meetings, to collaborator sites, or to contract organizations including serving as a technical SME during quality audits. Some international travel may be required.
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