Black Dog & Associates would like to welcome John W. Manski to our team of consultants. John is a proven leader with more that 30 years of experience in technical operations at pharma manufacturing sites. He has demonstrated skills in analytical method development in research and development, quality control, technical services and laboratory management. A strong track record of accomplishment, customer focus, problem solving, and colleague development. Recognized as an expert in analytical chemistry with experience supporting both Drug Product and API GMP(Good Manufacturing Practices) Pharmaceutical Operations.
Areas of Expertise
Drug Products (DP), APIs, GMP, Technical Support, Analytical Chemistry, Method Development, Technical Expert-HPLC, Quality Control, R&D, Laboratory Management, Complex Problem Resolution, Collaborative Communication, Performance Driven, Customer Focused
Professional Experience
Pfizer Inc., Kalamazoo, MI
Director|Team Leader, Process and Product Technology (PPT), May 2017 – November 2019
Led a team of up to 80 Scientists, Technicians, and Operators supporting GMP Drug Product (Injectables, Liquids, Semi-Solids) and API Operations. The technical teams included synthetic organic chemists, chemical engineers, microbiologists, analytical chemists, and formulators.
- Member of the Kalamazoo Site Leadership Team that led over 2300 colleagues producing 100 API and 150 Drug Products and managed an annual operating budget of more than $500MM.
- Led the the techical team that developed and implemented new processes|products for both Pfizer and third party customers resulting in process improvements that improved product quality, optimized cost savings, and reduced cycle time.
- Expanded Trace Analysis support to other Injectables sites in the network. Team provided direct support for these sites and helped them develop local capability.
- Developed team expertise in process safety data including thermal stability and dust explosivity testing.
- Facilitated development and implementation of the future vision for the fermentation pilot plants including staffing and capital needs that improved the long-term reliability of the operation.
- Led a team to implement ACT Workkeys basic skills testing to pre-screen applicants for operator roles optimizing high performance metrics for the team and improved employee retention rates.
Senior Manager|Team Leader, Process and Product Technology (PPT), April 2003 – April 2017
Built the PPT Analytical group from the ground up into a world class analytical support team through key hires, colleague development, and the addition of new capabilities and instrumentation.
- Created the Incident Support Group that provided analytical support to and API Operations that has become an invaluable asset to the site including providing leadership opportunities in development processes and product knowledge, problem resolution skill and management capabilities.
- Collaborated with Pfizer Regulatory and to align Regulatory Starting Materials that limited process details in filings, and push back on tightening of specifications that resulted in protecting the site’s ability to supply and make process improvements.
- Provided guidance and counsel to leadership team peers as the informal leader of the team.
- Demonstrated commitment to safety as the Leadership Safety Rep for the team for 4 years.
- Co-led the Talent Acquisition sub-team for the site that accelerated the hiring processes from candidate identification to onboarding.
Additional Relevant Roles at Pfizer
Group Leader Marketed Product Support|Global Chemical Process R&D
Provided analytical support for hundreds API Quality investigations each year. Led a group of up to four Lead Scientists and eight Associate Chemists.
- Expanded analytical support to include Trace Analysis and PC1 Regulatory and customer support.
Scientist II, Analytical R&D
Provided analytical support, primarily HPLC, for hundreds of API Quality investigations each year. Developed support model and methodologies such as HPLC impurity profiles and extractables still in use today.
Supervisor, QC Analytical Testing Laboratory
Led HPLC|GC Laboratories in the in-process QC Labs with accountability for up to 23 analysts and technicians in a 24×7 environment
- Reduced average HPLC assay turn-time to less than 2 calendar days.
- Supported implementation of LIMS and GMPs into the in-process QC Labs.
Chemistry Associate II|I, Analytical R&D
Analytical method development (primarily HPLC), method troubleshooting, plant support, QC Labs support.
Education
Bachelor of Science, Chemistry – Clarion University of Pennsylvania, Clarion, PA
Significant Awards
- Kalamazoo Site Quality Champion Award – 2015
- Kalamazoo Site Year End Award – 2011
- Kalamazoo Site Year End Award – 2006
- Excellence in Exhibiting Best Managed Behaviors Award – 2002
- Global Supply Operations Leadership Excellence Award – 2000
Affiliations
- American Chemical Society, Member
- Board Member on the Michigan Chemistry Council – 2018-2019
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