Thirty four years of experience in pharmaceutical manufacturing operations, engineering and facilities management. A flexible leader who embraces opportunities and who can be counted on to organize, coach and support colleagues to achieve department and company objectives. Fluent in current good manufacturing practices (cGMP) and industry quality, compliance and reliability drivers. Management and shop floor experience
Thirty four years of experience in pharmaceutical manufacturing operations, engineering and facilities management. A flexible leader who embraces opportunities and who can be counted on to organize, coach and support colleagues to achieve department and company objectives. Fluent in current good manufacturing practices (cGMP) and industry quality, compliance and reliability drivers. Management and shop floor experience in designing and implementing institutional programs and systems that embrace the challenge of producing pharmaceuticals in a changing industry, and escalating regulatory environment.
Specialties: Solid dosage and capsule manufacturing, organizational leadership, budgeting, utilities, electrical engineering, human resources, union negotiation, microsoft office, safety, SAP
Director of Manufacturing and Facilities @ Operations lead for solid dosage manufacturing operations and maintenance. From January 2011 to Present (5 years) Senior Director, Global Operations @ Facilities Director overseeing operations at three diverse pharmaceutical sites; chemical pilot plant manufacturing, vivarium R&D and clinical warehousing. From October 2003 to December 2010 (7 years 3 months) Senior Director @ Global Operations - North Country
Portfolio of services managed and delivered includes engineering, maintenance, central utilities, security, housekeeping and material and waste management. Major job functions:
Direct management and leadership of 103 employee department, delivering services to a customer base of 400 research employees engaged in drug safety Vivarium, chemical pilot and clinical packaging operations.
Development and oversight of ~$20MM annual expense budget.
Execution and oversight of annual capital budget; $40MM over the last three years
Management of EH&S services overseeing pathological, hazardous, institutional and re-cycling waste streams.
Energy management and development of demand side efficiency projects.
Proven leader in a unionized work environment. Member of management team that successfully negotiated three labor agreements, covering 18 years.
Voting member of site Institutional Animal Care and Use Committee.
Twenty-eight years of experience in pharmaceutical and site engineering along with progressively higher management role, provides background to effectively oversee facility operations at three sites executing diverse set of work streams;
Drug safety Vivarium executing GLP studies. Site is 350,000 sq. ft. of Vivarium, office and support space including utility and waste water functions.
Chemical pilot plant operations including manufacturing of active pharmaceutical ingredients and scale-up of research compounds for clinical trials. Site is 150,000 sq. ft. under roof with process reactors, infrastructure and waste handing capabilities needed for hazardous material processing across a wide temperature and pressure range.
Clinical packaging warehouse. Site is 50,000 sq. ft. and handles secondary packaging, distribution and warehousing of material used in Pfizer clinical trails. From January 2003 to December 2010 (8 years) Various @ Hired as a junior project engineer, with BS in Electrical Engineering. Gained experience working in manufacturing (solid dosage, liquid, sterile products) and infrastructure projects. As Associate Director of Facilities, managed a 200 employee department with $30MM/year expense budget. From January 1981 to January 2003 (22 years 1 month) Energy Procurement Engineer @ From January 1981 to January 1981 (1 month) Energy Supply Engineer @ From January 1980 to January 1981 (1 year 1 month)
B.S, Electrical Engineering @ University of Vermont From 1975 to 1980 John Nichols is skilled in: FDA, GLP, Operations Management, GMP, Engineering, Pharmaceutical Industry, Validation, Sop, Cross-functional Team Leadership, Facilities Management, Leadership, Technology Transfer, Change Control, Biotechnology, CAPA
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