Anthony Nicola

Validation, Engineering and Manufacturing Science & Technology director with a proven record of excellence in project management, equipment and facility qualification, computer systems validation, product and cleaning validation, technology transfer, training, and regulatory compliance. Results-oriented leader proficient in team building, procedure development, and risk management. Expansive scientific background and instructional experience, with a history of accomplishment, driving innovative problem resolution.

JUBILANT CADISTA PHARMACEUTICALS

Associate Director, Manufacturing Science and Technology
Responsible for the overall functioning of the newly-created Manufacturing Science and Technology Department for an oral-solid dosage manufacturing plant, reporting to the Vice President and Site Head of Operations.

Associate Director, Validation / Sr. Manager, Validation / Manager, Validation
Administration of the equipment / utility / facility validation program for an oral-solid dosage manufacturing plant. Oversight of a team of three direct reports and 10+ contract individuals. Management of budgets for the validation team and preparation of multi-year plans based on anticipated project loading. Responsible for hiring, training, promotion, and discipline of reports within validation group.

Sr. Validation / Project Engineer
Project management of the validation efforts for a facility renovation involving the manufacture of a potent solid-dosage form. Managed two separate contract validation groups (5 individuals at a time) working on the project. Developed budgets and schedules, and awarded contracts for the validation efforts.

SYNTHES USA, INC.

Quality Engineer, Validation
Oversight of an orthopedic medical device manufacturing plant qualification and validation program.

ASTELLAS PHARMA MANUFACTURING, INC.

Senior Validation Scientist (Progressed through multiple positions of increased responsibility, including Validation Technician and Validation Scientist)
Development of Validation Master Plans for Facility / Utility / Equipment Qualification, Process Validation, and Cleaning Validation, for a Topical Dosage Form Manufacturing Plant.
 

PhD., Analytical Chemistry, University of Pittsburgh

Quantification of Biomolecules Using Time-Of-Flight Mass Spectrometry