John Pizzonia PhD

Branford, Connecticut ***** 203-***-**** acp5j8@r.postjobfree.com

Objective

To use my passion for science and my business acumen to manage a company’s EHS objectives.

Summary

A Safety minded Senior Scientist with 20 years EHS Program Management experience in the Life Science market space. Proven expertise in the design and implementation of Environmental, Health and Safety programs for Chemical, Biological, Radiological, Fire and Electrical environments including Ergonomics and Risk Assessment/Control. Highly knowledgeable and practiced in achieving compliance on OSHA, FDA, NRC, DEEP, DEA and ISO’s as well as local, state and federal safety requirements, regulations and guidelines through the development of robust quality programs. A respected leader, monitoring and motivating employees at all levels toward corporate objectives.

Core Competencies

OSHA / Regulatory Compliance

Auditing

Cost Control

Quality Assurance/Control

Operational Management

Internal Controls

Change Management

Research & Development

Leadership & Motivation

Process Improvement

Vendor/Stakeholder Management

Training & Development

Policy Development

ISO Registration/Implementation

Customer Service

Project Management

Presentation

Logistics

Professional Experience

Naturemost Laboratories [Middletown, CT]

Oct 2013 to Nov 2014

Provider of nutraceutical dietary supplements.

Director of Quality

Managed a team of 10 and a $150k budget for a cGMP manufacturing facility and testing laboratory

Implemented FDA Part III/cGMP quality programs and ensuring compliance with OSHA and BSL2

Achievements:

Increased revenue by 20% within the first year, significantly improved quality control and added new products

Addressed FDA 483 warning received prior to employment and developed a remediation program, in collaboration with FDA, to achieve full product and facility cGMP compliance

Set up Vendor Audit Program for cGMP Supplier Qualification Requirement, establishing on-site audits with 15 inspections of vendor facilities and documentation

Reduced testing costs with design and build of BL2-ISO17025 microbial testing laboratory

Bruker Biospin [Woodbridge, CT]

Oct 2012 to Sep 2013

Provider of preclinical PET, SPECT, MRI, CT and optical imaging solutions.

Laboratory Director

Worked with architects, operations and management to design facility including wet bench, vivarium, and product demonstration showroom managed the site with 2 employees and a $300k operating budget.

Integrated Quality, Safety and Regulatory Programs, documentation and processes to new owner’s corporate structure and best practices

Prepared worldwide regulatory compliance for X-ray and anesthesia/rebreathing systems

Maintained site EHS programs including OSHA, FDA, DEA, EPA, NRC, and IACUC compliance

Led product quality development, anesthesia support systems and preclinical nuclear X-ray, PET, SPECT, CT imaging systems regulatory compliance

Achievements:

Streamlined R&D and Sales operations for new product development and maintained existing revenue streams.

Designed new laboratory facility to support PET/SPECT product R&D and customer training, delivered on schedule and within parameters

Secured Radioactive Materials License to support laboratory product development

Carestream Health - Molecular Imaging Systems [Woodbridge, CT]

Oct 2009 to Sep 2012

Molecular Imaging Systems for in vitro & in vivo imaging needs sold worldwide into academic and industrial markets.

Applications Laboratory Director

Managed a 4,000 ft2 laboratory including a wet bench laboratory facility, a small animal vivarium and product demonstration showroom with a staff of 5 and a $250k operating budget

Introduced Lean Six Sigma applications, site safety requirements and GLP policy procedures

Established Federal Health Service compliance for OSHA, EPA, DEA, NRC and DEEP, developed product and facility regulatory radiation safety compliance and maintained DEA Schedule II Controlled Substances License

Devised a program to meet all local, state and federal safety requirements for fire, electrical, chemical, radiation, biological, first aid, industrial hygiene and ergonomics

Maintained PET isotope research and X-ray program with NRC and FDA for worldwide product distribution

Established an Institutional Animal Care and Use Committee and served as the local IACUC Coordinator

Designed and implemented a rodent vivarium to support R&D, Sales and Customer Support and applied for Office of Laboratory Animal Welfare accreditation

Achievements:

Addressed product defects utilizing Lean Six Sigma Principles to track and decrease out-of-box defects by 65% and improve customer satisfaction by 20%

Developed in-house preclinical imaging demonstrations resulting in four direct system sales

FujiFilm Medical Systems USA [Woodbridge, CT]

May 2006 to Aug 2009

Film, CCD camera systems, laser scanners and surface Plasmon resonance solutions for academic and industrial use

Laboratory/Site Director

Established and managed a 4,700 ft2 wet laboratory and product demonstration area and also supported R&D with a small team of laboratory staff and an annual operating budget of $200k

Provided onsite technical sales support throughout the US and Canada with a sales team of 9

Developed an ISO9000/ISO14000 Quality System based on the corporate model and an OSHA compliant General Safety Program maintained with an internal facility audit program

Prepared ISO9001/13485/14000 registrations for business unit and facility.

Compiled documentation and provided training for Electrical issues, Emergency Action/Exit Plans, Fire Prevention, Personal Protective Equipment, Equipment Safety, Lock-out/Tag-out procedures, Hazard Communication, Blood-borne Pathogens, Ergonomics and Industrial Hygiene.

Achievements:

Personally selected to establish Fujifilm Medical Systems in the US Market and establish wet laboratory

Maintained an accident free facility for three years

Increased annual sales by $100k

Reduced operational expenses by 14% for 3 years, maintaining product quality and facility safety

Returned Business Unit to profitability resulting in a product portfolio sale to GE Healthcare

Kodak Health Imaging - Scientific Imaging Systems, [New Haven, CT]

Jun 1999 to Apr 2006

Small business unit providing academic and industrial research markets with film and digital imaging solutions.

Senior Scientist

Provided technical customer support on product range as Application Scientist

Ensured laboratory compliance within corporate guidelines and local, state and federal laws

Led System 9000 software integration and ISO9001 quality program to achieve compliance and certification

Developed effective and compelling sales demonstrations for customer site presentations

Completed registration, training, and BRU audits required for US and European distribution

Served as Business Unit Safety Manager ensuring biological, chemical, nuclear and environmental safety while maintaining optimum laboratory efficiency

Achievements:

Promoted to Laboratory Manager leading R&D and Sales support of a 5 state art digital imaging system release

Developed a Corrective Action program to address declining client satisfaction during transition from film to digital imaging. Resolved 97% of requests, improving client satisfaction and new product acceptance

Expanded Digital Imaging Systems to include small animal vivarium for preclinical imaging applications

Innovated a new product to offset losses from declining film sales

Affiliations

Yale University School of Medicine, [New Haven, CT]

Jun 1998 to Apr 2002

Academic leader in life sciences consistently ranking among the top medical schools for NIH funding.

Adjunct Research Scientist – Department of Obstetrics and Gynecology

Yale University School of Medicine, [New Haven, CT]

May 1995 to Apr 1998

Associate Research Scientist – Department of Neuroscience

Achievements:

Perfected organotypic and co-culture of Human neuronal and glial cells resected from clinical epilepsy patients for research models in electrophysiology and molecular biology

Education & Certification

PhD

Pharmacology

Ford Foundation Pre-doctoral Fellowship - Dartmouth Medical School, Hanover, NH

BA

Biology & Psychology

State University of New York, Plattsburgh, NY

Radiation Safety, First Aid, Internal & External Auditing • ASP/CSP certification In Process

Professional Society Memberships

American Society of Safety Engineers

American Society for Quality

Society for Nuclear Medicine

Society of Neuroscience

American Conference of Governmental Industrial Hygienists

American Society for the Advancement of Science

American Society of Cell Biology

Society for Molecular Imaging

American Association for Cancer Research

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