Business Development Safety Manager

**** ****** **. ********, ** *****

443-***-**** (cell)

*******@*******.***

Patricia Hartman Grier

Summary of Qualifications Self-starter, highly motivated, team player, passionate about career; Experienced scientist, laboratory manager, and regulatory

HSE manager/director. Responsible for build-up of three laboratories and establishing laboratory management protocols and HSE programs.

Professional Experience

Feb. 2020 – Present Pharmaceutics International, Inc.

EHS Officer/Manager

Responsible for all aspects of safety program for Pii

Reversed the facility TRIR metrics from 2.5 to 0.43 in 16 months;

Revised EHS budget, contractors, and support system to save approx. $850K in hazardous waste contracts annually

Modified and established EHS program to be Behavior Based with complete Management support and incorporating safety into performance evaluations and goals

Responsible for facility security for 300+ employees at 5 facilities

Manage all product safety for API’s and other products writing Handling Safety Assessments specific to facility requirements for all reagents, chemicals, API’s entering facility

Manage all licensing, inspections, audits, reporting and certifications for 5 facilities

Manage team of 5 EHS Coordinators and Plant Managers in regards to EHS and Corporate Security

Involved in reviewing plans, and prints to build out and construct new Aseptic Manufacturing suite, responsible for licensing and certification of new facilities

Established corporate Pandemic Policy during COVID-19 and trained managers/supervisors/ and leadership team on procedures, protocols, and contact tracing for the organization

Created Incentive program for vaccination of employees, resulting in 72% of employees being vaccinated, and keeping our positivity rate below 1.8% during all months of the pandemic thus far. Contact tracing and data indicate no cross contamination has occurred at Pii during pandemic thus far.

Jan 2013-Jan 2020 Consolidated Forensics Laboratory (CFL) Washington, DC

Safety Manager

Responsible for all aspects of safety program for the CFL

Responsible for facility security – badge and iris scan; contractors and vendors background checks

Liaison between facility engineers and agency to facilitate all repair actions and operations within the facilities

Risk Manager and Emergency Response Manager for agency and facility

Manage contracts for facility and laboratories (waste handling, medical surveillance, asset management, HVAC and electrical repair contracts, custodial contracts)

Responsible for establishing and maintaining corporate contracts for PPE, medical surveillance, waste management, metrology and asset management; $800K budget.

Established ISO17025 accreditation, CDC DSAT accreditation for Select Agents, and CLIA and CAP accreditation with Public Health Laboratory

Developed, wrote and implemented Biosafety, Biosecurity and Suitability Assessment Plans for BSL3 and DSAT programs

Maintain licensures and certifications for facility and tenants

Enforce compliance and regulation of all tenants consisting of Metropolitan Police Department; Office of the Chief Medical Examiner; Forensic Science Laboratory; Firearms and Fingerprint Laboratory; and Public Health Department for DC; 400 total employees

Responsible for establishing EHS program and training for all employees (Biosafety Manual, Chemical Hygiene Program, Hazard Communication Program, Bloodborne Pathogen Program, Incident Reporting System, Contractor Safety Program, ARC Flash, Medical Surveillance Program, COOP Plan, and Emergency Response Plan, etc.)

Member of Office of Risk Management DC government; assist in bringing EHS and OSHA regulations to the forefront in DC Forensics Lab

Conduct Risk Assessments, Job Hazard Analyses, Biohazard Evaluations, and Threat Evaluations

Perform annual building inspections, laboratory inspections, policy reviews, and risk assessments

Aug 2007-Dec. 2012 Human Genome Sciences, Inc. Rockville, MD

Sr. Safety Engineer

Corporate Biological Safety Officer for all Laboratories

Corporate Radiological Program Officer

Corporate Chemical Hygiene Officer

IACUC member and safety representative

Develop and maintain Bloodborne Pathogen Program and Employee Medical Surveillance Program

Establish and conduct health fairs and clinics for approx. 900 employees

Write SOP’s, CHP, Biosafety Manual, BBP Exposure Plan, Radiation Safety Manual, Control Substance Policy

Responsible for training BBP, Laboratory Safety, CHP, HAZCOM, and all other safety trainings for 900 employees

Conduct inspection audits, surveys, and communicate with regulatory agencies

Assisted in designing and establishing several new BSL1 &2 laboratories and manufacturing suites

Coordinate and oversee corporate monthly safety meetings for research labs, manufacturing and administrative departments

May 2006-August 2007 Advance BioScience Laboratories Kensington, MD

Environmental Health and Safety Manager

Responsible for all aspects of employee health and safety program – training, licenses, workman’s comp, radiation, chemical and biohazard use and waste programs

Radiation Safety Officer, DOT/IATA certified, OSHA certified

Created and maintained employee training and medical surveillance programs and databases

Established and conducted health fair and clinics

Conducted orientation and annual training for all personnel

Obtained and maintained state, federal and local licenses for animal and research facilities

Wrote SOP’s, CHP, Biosafety Manual, BBP Exposure Plan, and monthly safety newsletters

Conducted audits and inspections for biomanufacturing, R&D, and animal facilities

Member of IACUC committee

Responsible for overhead budget of safety program and maintaining service contracts

Assisted in design and renovation of new BSL2/3 and biomanufacturing laboratories

Mar 2005-April 2006 Merck & Co., Inc. West Point, PA

Lead Tolling Release Coordinator

Responsible for three tolling contract facilities and release of their product to market

Created three month inventory for (2 month backlogged) product in eight months

Reviewed 20-30 MBR documents per month for cGMP compliance issues and discrepancies and resolution of issues with contractors

Released product within 48 hours after all atypicals and document issues resolved

Conduct and write investigations for adverse manufacturing events of vaccines

Responsible for licensing, validation, release, and investigation of products

Adhere to cGMP, cGLP, FDA, CDER, CBER, OSHA regulations

Ensure market demands are met for vaccine and sterile products

Mar 2004-Mar 2005 Merck & Co., Inc. West Point, PA

Lead Release Coordinator

Responsible for release of two product lines and all sterile diluent for vaccine quality division

Created a four month inventory of products in backlog status

Revised and submitted licensures and protocols for ELSPAR and BWS product lines

Assisted in technology transfer of products to outside contractors

Dec 2002-Mar 2004 Merck & Co., Inc. West Point, PA

Release Coordinator

Responsible for release of Recombivax Vaccine to meet market demands

Assist in writing contextual reviews, protocols, and investigations for product line

Assist in audits, inspections, and upgrades of SOP’s for release of vaccines

Evaluated and inspected 50-75 MBR per month for Sterile Product Release Department

Sept 2002-Dec 2002 NIAID, Biodefense Program NIH Rockville, MD

Health Scientist

Investigate and report laws, construction requirements, and building codes for newly appointed Homeland Security Program for BSL laboratories, facilities, vivariums

Established databases and grant material for $50 million budget

Prepared and conducted symposiums and international meetings for Homeland Security Program

June 1996-Sept 2002 Center for Prostate Disease Research Rockville, MD

Laboratory Manager/Safety Coordinator

Managed all aspects of cancer research laboratory facility, basic science program, cell/tissue culture laboratory, and virus production laboratory

Designed, created and maintained databases for procurement, budget, training, property, tissue and cell culture banks, chemical inventory, MSDS, and SOP’s

Supervised 6 direct reports and 35 researchers

Spearheaded design of new laboratory facility, and required licensures

Responsible for $5 million scientific budget; including purchasing of research equipment, animals, supplies

Established and maintained licensures and contracts for hazardous waste, NRC, EPA, and facility

Wrote and published Safety Manuals. Training manuals, SOP’s, CHP

Prepared and reviewed protocols for NIH, DOD, and competitive grants, and animal protocols

Conducted inspections and annual reviews

Responsible for training of all laboratory personnel

Hired, trained, and discharged personnel; conducted annual performance reviews

Advised investigators and researchers of research project requirements and assisted in designing research

April 1990-June 1996 Ruminant Nutrition Lab, USDA Beltsville, MD

Support Scientist

June 1986-April 1990 Milk Secretion Mastitis Lab, USDA Beltsville, MD

Biological Lab Tech/Biochemist

Mar 1985-June 1986 Milk Secretion Mastitis Lab, University of Maryland Beltsville, MD

Lab Scientist III

Education March 1985 Ohio State University Columbus, OH

Masters of Science – Animal Physiology/Dairy Science

June 1980 University of Maryland College Park, MD

Bachelors of Science – Pre-Vet/Animal Science

June 1977 Prince Georges College Largo, MD

Associate of Science – General Studies/Biology/Chemistry

Certifications Radiation Safety Officer – Radiation Safety Academy 2007

DOT/IATA – DOT Compliance Training 2011, 2007, 2013

OSHA and Hazwhoper – 2012, 2011, 2009, 2007, 2002

Control of Biohazards Course – 2012

OSHA 511 Course – 2012

First Aid/CPR/AED – 2013

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