CAROLE D CROWE

** ******* ******, **********, ** 19807

302-***-**** (cell) acba9l@r.postjobfree.com

QUALITY ASSURANCE & REGULATORY AFFAIRS PROFESSIONAL

Experienced analytical chemist with FDA and EPA regulatory compliance background. Team player with solid knowledge of cGMP/GLP, ISO and ICH guidelines. R&D, manufacturing, regulatory and project management experience for small molecule API’s and biopharmaceuticals.

• Compliance ● Competitive Marketing Intelligence

• Quality and Supplier Audits ● Presentation Skills

• Project Management

PROFESSIONAL EXPERIENCE:

Agilent Technologies, Wilmington, DE 2009 - 2013

Compliance Engineer

Compliance Lead Project Manager for a $40 million service project with a top tier Pharmaceutical Company. Pre and post-sales support for Compliance Service Products; technical writing, tactics and strategies for sales and marketing support.

• Presentations on Compliance and Regulatory Trends at US and International Conferences

• Consulted with customers on Regulatory Risk and Total Quality Systems assessment

• Technical support for analytical instrument qualification software product

WuXi AppTec (formerly AppTec), Philadelphia, PA 2007 - 2009

Stability Program Manager

Overall responsibility for a biopharmaceutical contract manufacturing organization’s stability program. Increased annual program revenue over 3-fold to $1.8MM

• Applied understanding of submission requirements, regulatory guidelines and CTD to

support client’s IND, NDA and BLA filings

• Interacted directly with US and global clients to design stability programs and manage

these programs from inception through the entire length of each study. Generate final

stability study summaries and CMC reports

• Collaborated with QC/Analytical and QA to problem solve and author CAPA’s, OOS,

deviations and events

GlaxoSmithKline (Biopharmaceutical Division) Conshohocken, PA 2006 - 2007

Biochemical Specialist

Project team bioanalytical scientist in support of manufacturing, scale-up and technology

transfers of mammalian-cell culture-based bulk protein production for commercialization

• Provided technical support to manufacturing during toxicology/engineering runs to insure

proper tech transfer and scale up

• Trend analysis for manufacturing reproducibility and specification setting

• Lab assessments, CAPA’s, instrument validation, SOP’s and internal audits

Rhodia, Inc. (Rhodia Pharma Solutions) Deepwater, NJ 2000 - 2006

Sr. Scientist - Analytical Sciences

Analytical method development chemist responsible for tech transfer, validation, stability and quality control for cGMP pharmaceutical, small molecule API contract manufacturing facility

• CMC analytical responsibilities for Phase III drug candidate supporting IND/NDA filings

• Project management/costing and technical leadership

• Direct customer interface, batch record review and FDA inspection audits

• Developed LC and LC/MS methods for process intermediates and impurities

• Introduced new analytical technology resulting in new business opportunities

E. I. DuPont de Nemours Company, Wilmington, DE

Regulatory Manager - Agricultural Products Department 1991 - 1999

Managed regulatory, financial and contract strategies to support post-patent litigation and Regulatory Data Compensation issues within DuPont’s US Ag Products Business. Generated $1 to $2 MM annually.

Ag Residue Lab Supervisor - Agricultural Products Department 1987 - 1991

Managed daily operations for an analytical residue lab of nine chemists and technicians under GLP guidelines. Annual operating budget of $500M.

Development Chemist - Medical Products Department 1984 - 1987

Developed clinical assays to test engineering specifications for a new high-throughput diagnostic analyzer

EDUCATION:

M.S. Quality Assurance/Regulatory Affairs - Temple University, School of Pharmacy (2012)

M.S. Chemistry - Villanova University

“Purification and Characterization of an Invertase Enzyme from Strep.Salivarius SS2”

B.S. Chemistry - University of Delaware

PROFESSIONAL ORGANIZATIONS:

Parenteral Drug Association (PDA)

International Society of Pharmaceutical Engineers (ISPE)

The Chromatography Forum of the Delaware Valley (CFDV)

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