Steve is a proven leader with more than 30 years of experience in enzyme and microbiologic process development and fermentation manufacturing of large and small molecule pharmaceuticals. He has demonstrated expertise of biosafety and GMP requirements for enzyme and small molecule fermentation. He combines this knowledge with a strong track record of accomplishment, customer focus, problem solving, and colleague development in a pharma environment.
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Michael Reschke has more than 30 years of operative and managerial working experience in the production of steroidal Active Pharmaceutical Ingredients (APIs). His key areas of expertise are the large-scale fermentation of steroid intermediates (4-AD, 1,4-ADD and many others) and the detailed knowledge of all aspects of the steroid API business including research & development, technology and chemistry, quality and regulatory requirements, as well as established relations to most players in the worldwide steroid business.
Career
Reschke Technology
Consulting UG 2014 Start of own consulting company Key area of expertise: production and marketing of steroid APIs and intermediates
Support of clients in production related topics including: · Biotransformation of sterols and steroids (fermentation and downstream processing) · Process development and optimization (regarding yield, product quality, output, energy consumption etc) · Process engineering (design, optimization and maintenance of technical equipment) · Planning and layout of production plants · Sustainable API production (EHS, safety) · GMP requirements for API and intermediates production · Audit preparation (quality, EHS and sustainability audits) · Procurement of strategic raw materials Support of clients in business related topics including: · Steroid market investigations and surveys · Information on new results from R&D · Evaluation of suppliers for steroid APIs and intermediates including auditing · Provide established contacts to most relevant companies in the worldwide steroid market, including producers and customers of intermediates and APIs, producers of key raw materials, and traders
Bayer HealthCare 2013 Termination of Bayer contract on August 31, 2013.
2011 Procurement Germany, Head of Local Sourcing Raw Materials Responsibility: Raw materials sourcing for all Bayer HealthCare production sites in Germany (2 API sites and 5 pharmaceutical sites).
2007 Procurement Bayer HealthCare, Strategic Sourcing Manager Hormones Responsibility: Raw materials supply for the steroid API production in Bergkamen, Germany, and Orizaba, Mexico. Major tasks: Qualification of several suppliers for steroidal APIs and intermediates. Performance of supplier audits (quality, EHS, sustainability).
Schering AG
2005 Head of Procurement Bergkamen Responsibility: Supply of raw materials and technical goods for the API production site in Bergkamen, Germany. Major task: Installation of external suppliers for APIs, intermediates and strategic raw materials for steroid and contrast media production in Bergkamen. Visit and evaluation of potential suppliers in Europe, USA, Mexico, India, China, Japan, Taiwan, Singapur.
2002 Senior Head of Microbiological Production and Development Responsibility: Complete small molecules fermentation at Schering AG. Integration of Microbiological R&D into the Production Department. Major tasks: Research focus on development of genetically modified microorganisms (GMOs) for steroid biotransformation. Cooperation with several European Research Institutes. Installation of new equipment suitable for GMO production.
1999 Head of Microbiological Production (Fermentation and Recovery) Responsibility: Complete large-scale biotransformation processes at Schering AG with fermenter volumes from 50 to 230 m³ with the key focus on sterols fermentation to 4-AD and other intermediates. Major task: Enlargement of total production capacity due to growing Third Party business (for pharma companies in Europe and USA).
1990 Head of Recovery Plant Responsibility: Isolation of all biologically generated small molecules (mainly hormones and corticoids) at Schering AG. Major tasks: Organization of the regular production according to the scheduled production orders. Continuous process improvement, e.g. establishment of new technologies for direct extraction of fermentation media and integration of chemical reaction steps into the product isolation and purification.
1984 Process Chemist at Microbiological Production, Recovery Plant Location: Schering’s major API production site in Bergkamen, Germany. Responsibility: Development of isolation and purification processes of steroidal intermediates from fermentation media (biotransformation). Major tasks: Installation of a large-scale, fully computer-controlled production plant for the isolation of steroids from biotransformation processes with a capacity of several hundred to/year. Development of technical and process details for the complete equipment (extractors, evaporators, separators, reaction vessels, filters, centrifuges, dryers); responsible for equipment qualification and process validation.
Society for Biotechnologi-
cal Research (GBF) 1983 – 1984 Recovery of bioproducts from fermentation media.
Education
Thesis 1980 – 1983 Technical University of Hanover, Germany Graduate Thesis: Reactive Extraction of Penicillin G.
Social Service 1975 – 1977 Hanover Medical School, MHH, Hanover, Germany
University 1971 – 1980 Master of Chemistry, Technical University of Hanover, Germany
School 1971 Final Examination (Abitur) 1959 – 1971 Primary, Secondary and Highschool in Hameln, German
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