Manager Manufacturing

SUMMARY

Research and Development Manufacturing Scientist with successful track

record of pharmaceutical process development, clinical product

manufacturing, process validation and transition to routine commercial

manufacturing. Significant accomplishments include two implant products

successfully manufactured, tested in clinical investigations and approved

by global health authorities. Excellent communication and collaboration

skills enabling successful managed relationships with external vendors and

contractors.

. Manufactured two polyurethane implant products which resulted in

successful clinical trials.

. Increased the delivery rate of one polyurethane implant product

greater than the expected level and ahead of schedule.

. NDA submissions of both the Vantas and Supprelin LA implants were

approved on first cycle review.

. Validation and initial commercial lots for both Vantas and Supprelin

LA implants were successfully completed on schedule.

EDUCATION

M.S. - Pharmacology Graduate School of Basic Medical Sciences, New York

Medical College, Valhalla, NY

B.A. - Biology State University of NY at Purchase, Purchase,

NY

PROFESSIONAL EXPERIENCE

Associate Director, R&D - Endo Pharmaceuticals, Cranbury NJ - 2007 to 2014

(Legacy: Hydro Med Sciences,

Valera Pharmaceuticals, Indevus Pharmaceuticals)

. Collaborated with the R&D group to modify the formulation of the

Risperidone polyurethane implant in order to increase the drug

delivery rate. Delivery rate was increased beyond the 20% expected

level and project completion was two months ahead of schedule.

. Supervised the manufacture of two polyurethane implant products

which resulted in successful clinical trials.

. Co-lead team which planned and designed the construction of the

Clinical Manufacturing suites.

. Authored API cleaning verification protocols for clean rooms and

equipment used in clinical manufacturing. Supervised the execution

of the protocols.

. Developed design specifications for new production equipment and

collaborated with the manufacturers to ensure that the equipment

adhered to the user requirements.

. Wrote the factory and site acceptance tests (FAT and SAT) protocols

for new production equipment. Supervised protocol execution and

summarized successful results in technical reports.

. Collaborated with Facilities and QA Departments in the generation

of equipment change control forms, work instructions and IQ/OQ/PQ

protocols for equipment in the R&D Formulations Department.

. Supervised and trained team of two technicians in the R&D

Formulations Department for the manufacture of feasibility and

clinical drug implants.

. Approved equipment purchases and personnel hiring.

. R&D liaison responsible for the collaboration between the

manufacturing, technical services and QA departments.

. Resolved the technical issues which delayed the evaluation and

qualification of automated equipment required for polyurethane

implant manufacturing resulting in on-time completion of the

qualification.

Associate Director of Technical Services - 2005 to 2007

. Developed, implemented and validate all manufacturing process

improvements.

. Evaluated new manufacturing equipment, materials and processes;

authored proof of principle protocols, design specifications and

IQ/OQ/PQ protocols.

. Collaborated in the validation and set-up of the Steris Finn-Aqua

Sterilizer for use in the commercial manufacture of implants when

external contractor terminated service; post approval supplement

approved without comment.

. Led the investigations and wrote CAPAs related to drug implant

manufacturing deviations.

Manufacturing Technology Manager - 2004 to 2005

. Led manufacturing sub-team for the NDA submissions of Vantas and

Supprelin LA implants; both were approved on first cycle review.

. Contributed to the regulatory submissions for Vantas in Canada

and several European countries where it was also approved.

. Process validation and subsequent initial commercial lots for

both Vantas and Supprelin LA implants were successfully

completed on schedule.

. Directed the scale-up of the Histrelin implant from clinical lots

to commercial batch sizes (50% increase) and authored the

associated master formulas and work instructions.

Manufacturing Manager - 2003 to 2004

. Managed the Manufacturing Department which included 1 supervisor

and 6 operators.

. Supervised the production of the Vantas and Supprelin LA

clinical trial lots.

. Maintained clinical raw material inventory.

. Trained the manufacturing personnel in the production of Vantas

and Supprelin LA implants.

Laboratory Manager - 1999 to 2003

. Supervised three technicians in the QC and R&D Laboratories.

. Verified all raw material, in-process and final product testing

results.

. Reviewed all lab notebooks, test methods and protocols for

compliance with cGMP's and method validation (HPLC, GC, FTIR and

UV) packages for compliance with ICH guidelines.

. Evaluated all new API feasibility data.

. Developed, implemented and maintained laboratory test methods,

specifications and SOPs.

Senior Quality Control Auditor - ICM Laboratories, Inc., Randolph, NJ -

1998 to 1999

. Responsible for the final review of all data package generated in

the Environmental Laboratory including NY ASP, NJ CLP and NJDEP

reduced and regulatory deliverables.

Revised SOP's and maintained the laboratory's certification.

TRAINING/WORKSHOPS

Microsoft Excel - Beyond the Basics-Fred Pryor Seminars - 3/2014

Computer System Validation in FDA-regulated Industries Seminar - Validation

Associates, Inc. - 03/2012

Training for Piccola PLC Tablet Press 460 and Director Software - Specialty

Measurements Inc. - 02/2012

Hands-On Tablet Technology - University of Tennessee Health Science Center

- 06/2011

Workshop on Cleaning and Sanitizing Clean rooms and Controlled Environments

- IEST - 5/2010

Current Good Manufacturing Practices - Endo Pharmaceuticals - 04/2009

Sterilization Procedures: Technology, Equipment and Validation - CfPIE -

03/2009

Technical Writing in the Pharmaceutical and Allied Industries - CfPA -

01/2009

Implementing Best Practices for Cleaning Validation - PTI International -

05/2008

Implementing Key Requirements for Process Validation - PTI International -

04/2008

Contact this candidate