Director, Clinical Manufacturing @ Oncobiologics Inc.
Manager Technical Services @ Pall Life Sciences
Director of Contract Biologics Manufacturing @ WuXi AppTec
A highly organized and well-rounded operations leader with extensive experience in clinical & commercial manufacturing; technology transfer; and continuous improvement to achieve maximum productivity for the manufacture of highly complex biologics. Adept at examining current business functions and implementing strategic initiatives that reduce costs and improve efficiency. Proficient at cross-training staff members to conduct various tasks, as
A highly organized and well-rounded operations leader with extensive experience in clinical & commercial manufacturing; technology transfer; and continuous improvement to achieve maximum productivity for the manufacture of highly complex biologics. Adept at examining current business functions and implementing strategic initiatives that reduce costs and improve efficiency. Proficient at cross-training staff members to conduct various tasks, as well as ensuring all products are manufactured to the highest quality standards and in accordance with applicable regulations and procedures.
Director, Clinical Manufacturing @ Directed all aspects of manufacturing including facility engineering & design; technology transfer; upstream, downstream & aseptic fill finish operations; procurement & inventory control and facility & asset management. Collaborated with senior management and cross functional groups in order to develop manufacturing strategy for biosimilar candidates. Advised on process development activities in an effort to keep cost of goods (COGS) low in order to allow the biosimilar platform to maintain a competitive advantage in the marketplace.
• Design, build and operation of a 4,000 ft2 clinical manufacturing facility that utilizes single-use technology and embraces flexibility in order to support worldwide clinical/ commercial development of a multi-product biosimilar and innovative drug candidate pipeline within a budget of $2.5 million and a timeline of six (6) months.
• Directed the in-house technology transfer; and drug substance manufacturing operations for two biosimilar candidates within a timeline of eight (8) months.
• Directed the outsourced technology transfer; and drug product manufacturing operations for two biosimilar candidates within a budget of $300 thousand and a timeline of eight (8) months.
• Participated in the authorship of regulatory document for two biosimilar candidates within a timeline of six (6) months.
• Direct the facilities & engineering and shipping & receiving functions that service research and development; process development; and clinical manufacturing groups within the Oncobiologics, Inc. organization. From April 2012 to Present (3 years 9 months) Manager Technical Services @ • Recruited back to manage the newly formed Pall Life Sciences Technical Services group for the Mid Atlantic Sales Region.
• Responsible for all aspects of Technical Support to Pall Life Sciences’ Customers, Sales Specialists, Distributors, etc..
• General functions included the management of quote preparation; filterability performance; report authorship; filter integrity test performance; and Pall Life Sciences’ fee-based field-services. From September 2009 to April 2012 (2 years 8 months) Director of Contract Biologics Manufacturing @ Recruited back to direct the purification, support services and sterile formulation / filling contract manufacturing operations within a three-suite, multi-product facility. Target clients were representative of all phases of drug development (Pre-IND Toxicology, Phases I, II, and III) with therapeutic and diagnostic indications.
• Responsible for the technology transfer, scale-up, manufacture, final formulation / packaging, and release of 22 independent sterile products inclusive of monoclonal & polyclonal antibodies and recombinant proteins.
• Directed a staff in excess of 34 cross-functional associates; 6 supervisors and 2 managers.
• Managed a departmental budget of $5.5 million for capital and operational costs, as well as a client pass-through budget of $1.6 million.
• Participated in Six Sigma initiatives to increase process excellence by reducing deviations by 75%, and improving document review timeframes by 90%.\ From May 2006 to January 2009 (2 years 9 months) Biopharmaceutical Processing Specialist @ • Provided first-line product support for the Sales Team, targeting pharmaceutical and biopharmaceutical clients at the manufacturing and process-development levels. From June 2005 to May 2006 (1 year) Manager, Downstream Biologics Manufacturing @ Managed the purification contract manufacturing operations within a newly constructed 75,000 ft2 five-suite, multi-product facility. Target clients were representative of all phases of drug development (Pre-IND Toxicology, Phases I, II, and III) with therapeutic and diagnostic indications.
• Successfully completed facility startup; commissioning; and validation activities within six (6) months from the completion of construction.
• Successfully manufactured and released 2 cGMP compliant batches within six (6) months of from the completion of construction.
• Managed the procurement of all capital equipment within a budget of $10.2 million. From June 2003 to May 2005 (2 years) Supervisor, Downstream Support Services @ Initially hired as a Level II Operator to assist with commercial launch facility construction and startup activities for the manufacture of Erbitux®. Promoted to supervising all buffer and component preparation activities associated with Downstream Purification Operation at the completion of construction, technology transfer, initial validation and consistency batches (2002). From June 2001 to June 2003 (2 years 1 month) Manufacturing Technologist, Group Leader @ Responsible for the purification of cell-culture supernatants and ascites fluids, by utilizing Anion, Cation and Affinity Chromatography Methods, Tangential Flow Filtration, Final Formulation and Filling, resulting in a monoclonal antibody and diagnostic product for clinical and commercial use. From May 2000 to June 2001 (1 year 2 months)
BS, Biology @ Muhlenberg College From 1996 to 2000 Keith Lynch is skilled in: GMP, Validation, Biotechnology, Technology Transfer, Biopharmaceuticals, Downstream Processing, Purification, Chromatography, Filtration, Management, Sop, Nanofiltration, Lifesciences, Process Simulation, Monoclonal Antibodies
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