About us
PROFILE
A leader within the Pharmaceutical industry with extensive experience in international pharmaceutical and biotechnology operations, and regulatory science that strives to protect public health, and improve pharmaceutical industry effectiveness.
PROFESSIONAL EXPERIENCE
Jaworski Associates LLC, Burtonsville, MD December 2021 to Present
Member – Providing consulting and training services to government agencies and industry.
Parenteral Drug Association, Bethesda, MD October 2021 to Present
Senior Advisor (Part time) – Initiative project manager and advisor for member services.
FDA, Silver Spring, MD, June 2014 to March 2021,
Retired Consumer Safety Officer, Senior Policy Advisor, CDER, OC, OMQ
Responsible for developing compliance policy and guidance to industry. Advisor to OMQ management and compliance safety officers on compliance cases and new or developing regulatory issues. Instrumental in developing the Visible Particulate Inspection Guidance and COVID 19 guidances.
Member of Compounding Quality Center of Excellence team and team leader for the In Person Sterile Drug Compounding course.
Awarded FDA EMA fellowship to determine best compliance assessment processes and propose a shared compliance assessment process between EMA member countries and FDA.
Project leader to develop a standardized risk based enforcement action process that allows better compliance decisions within CDER Office of Compliance.
Project leader of a team that became a finalist in the HHS Ignite Accelerator program. This team is one of only two teams from FDA to enter the second phase of the program. This rapid enforcement action quality transformation team (REAQT) is focused on developing innovative solutions to improve the corrective action process, facilitate firm’s understanding of the real root cause of FDA observations, and develop more effective communications with industry when FDA investigators observe violations of GMP or poor drug quality.
Lachman Consultants, Westbury, NY June, 2012 to June, 2014
Director, Compliance Services
Provided worldwide consultation to industry on pharmaceutical manufacturing, quality management, and quality improvement. Worked on development of new technologies for client companies. Conducted mock MHRA and FDA inspectional readiness assessments for client companies. Key international clients were in Germany, France, Italy, Poland, Czech Republic, Switzerland, Sweden, and India.
FDA, Silver Spring, MD 2008 to 2012,
Consumer Safety Officer, CDER , OC, OMPQ
Acting Branch Chief, DDDQ, May, 2011 to June, 2012
Responsible for management of cases for administrative or regulatory actions.
Chairperson: Sterile Drug Compliance Discussion group. Actively involved in management of particulate mattercontamination in parenteral drugs. Presented CDER Compliance position to USP expert committee on particulatematter and inspection criteria.
Accomplishments: Member of Drug Shortage Investigation team and Change Management team.
Team Leader, DCMB, January, 2011 to May 2011
Responsible for management of cases for administrative or regulatory actions. Accomplishments: Project leader for strategic initiative of a Quality Evaluation System for companies to report status of quality each year.
Acting Team Leader, DCMB, January, 2010 to January 2011
Responsible for management of cases for administrative or regulatory action. This required application of the theories,principles and methods of consumer safety regulatory requirements, such as: Application of the FDCA, CFRregulations, and FDA policies.
Delivered presentations to industry on compliance issues and technical aseptic processing proposals.
Acting Team Leader for International Compliance Branch, June, 2009 to December, 2009. Responsible for management of the review process for inspection reports of foreign firms and taking appropriate administrative or regulatory action as necessary. Specifically developed procedures to solve critical problems such as revision of casemanagement procedures and initiation of case tracking project in CMS that would allow consolidation of caseinformation into one database and elimination of a non-supported database. Delivered presentations to industry on compliance issues.
Participated in weekly trusted partner meetings with Australia, Canada, EU to discuss regulatory issues with inspection of firms and shared findings of inspections.
Case Officer DCMB, October, 2008 – June, 2009
Responsible for review of compliance cases. Successfully completed fast track review and approval of the KV Injunctionand Caraco Mass Seizure cases. Edited and coordinated with OPS the final review and edits to the Guidance for Industryon Submission of Applications for Parametric Release
Pierrel USA, Inc. Elk Grove Village, Illinois 2007 – 2008
Business Unit Manager
Major Accomplishments:
Started up operations, relocated equipment to Italy, and completed orderly close of business in USA after start-up funding could not be obtained.
DENTSPLY Pharmaceutical, Elk Grove Village, Illinois 2004 – 2006
Director of Operations (2004 – 2006)
Start-up of pharmaceutical operations at repurposed facility.
IVAX, 4400 Biscayne Blvd, Miami, Florida 33137 1992 - 2004
Various Director level roles culminating in a corporate level Associate Director role.
Major Accomplishments:
Completed production scale up and addressed FDA deficiencies during the approval process for Paclitaxel Injection.Responsible for launch and back up manufacturing implementation activities. Obtained funding, and built ‘State of the Art” Aseptic Sterile Drug manufacturing plant. Required to identify equipment suppliers, finalize design specifications, develop Factory Acceptance test criteria, conduct tests in German, Sweden, Finland, and Canada.
Coordinated and managed the transfer of products to various plant locations including Ireland. This included allregulatory aspects of product transfer. Managed API manufacturing in Germany and sterile filling in Australia.
Oncor, Gaithersburg, MD 1992
Director of Manufacturing
Responsible for manufacturing and packaging DNA Probes for genetic disease and confirmatory
cancer screening.
Ernst & Young, New York, NY 1988 - 1991
Manager
Specialized in pharmaceutical manufacturing improvement and the application of World Class
Manufacturing strategies with client companies.
Sandoz Pharmaceuticals, Inc., East Hanover, NJ 1987 - 1988
Director of Pharmaceutical Production
Responsible for manufacturing and packaging oral and injectable prescription pharmaceuticals
with a $11 million budget.
Major Accomplishment
Established clearly defined start up program for the newly constructed ampoule facility, which resulted in a cleardefinition of project components, identification of resources, and scheduling of events. Trained in Switzerland to understand technology and European standards.
Bristol Myers Company, New York, NY 1978 - 1987
Department Supervisor (Syracuse, NY)
Advancing to Director of Pharmaceutical Production (Puerto Rico)
Abbott Laboratories, Rocky Mount, NC 1977 - 1978
Manufacturing Supervisor
William H. Rorer, Inc., Ft. Washington, PA 1974 - 1977
Control Chemist, Manufacturing Supervisor
EDUCATION
M.B.A.; Operations & Management • Syracuse University, Syracuse, NY, Graduated: 1985
B.S. in Microbiology • Pennsylvania State University; University Park, PA Graduated: 1973
Corporate Development • Wharton (Finance) • Levinson Institute (Leadership) 1986
Animal Cell Culture Methods and Scale-up Strategies, Pennsylvania State University, 2002
Basic Drug School. 2009. Preapproval Inspections, 2009, CDER Law 2009, Preceptor Training, 2011
PROFESSIONAL AFFILIATIONS
American Society for Microbiology
Parenteral Drug Association