Improver

Tim Breuninger

Assoc Dir Project/Program Manager Third Party Operations at Teva Pharmaceuticals

Washington, New Jersey

Pharmaceutical Senior Manager with strategic vision, emotional intelligence, and unwavering dedication to R&D, quality, regulatory, and commercial excellence while driving organizational transformation through business acumen and scientific leadership.

Demonstrated leadership, interpersonal, communication, technical, and management skills. Vision and drive to achieve organizational excellence. Skill set and personality to create and maintain a high level of motivation.

Currently pursuing a Doctor of Philosophy (Ph.D.) focused in Analytical Chemistry from Seton Hall University.

My career began in the Quality organization as a quality control chemist and advanced through the Quality Control management organization to Research and Development.

I have inspired and led teams performing all aspects of the Quality Laboratory organization including planning/budgeting, headcount, compliancy, knowledge share, method transfers, RM/FP release, and stability. Additionally, I have supported and lead R&D teams performing similar Quality functions and the development of drug products working with mostly small molecules and a few polypeptides/ proteins in various dosage forms (solid, injectable, injectable-with-device, oral IR / ER, transdermal, vaginal rings, creams) and drug-device combination products for a wide gamut of therapeutic areas.

I led, developed and implemented efficient strategies for Elemental Impurities (ICH Q3D), FDA Q1A (R2) Stability testing, and metrology functions within R&D. Additionally, I led and inspired the development of AQbD methodologies and implementation of new technologies.

FIRST-TO-FILE / FIRST-TO-MARKET FOCUS: Facilitated filing ANDA / IND / NDA submissions and amendments from development through approval and commercialization.

By bringing both scientific expertise and business acumen to my work, I minimize or eliminate inefficiencies. At the same time, my people-focused management approach engages and empowers teams.

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Experience:

• Assoc Dir Project/Program Manager Third Party Operations (Teva Pharmaceuticals)
• QC Technical Group Leader (Barr Pharmaceuticals)
• QC Manager and Sr. Manager (Teva Pharmaceuticals)
• ARD Sr Manager (Teva Pharmaceuticals)
• QC Chemist (Barr Pharmaceuticals)
• Assistant Rugby Coach at William Paterson University (William Paterson University)
• Sr. Project Manager Third Party Operations (Teva Pharmaceuticals)

Skills: