Director, Biopharmaceutics

Merck • Rahway, NJ, United States • $200k - $250k / year • 3w ago

Merck Director, Biopharmaceutics Rahway, New Jersey Apply Now

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. Our Research Scientists are our Inventors. We identify and target steps in disease mechanisms or pathways that could be inhibited or enhanced. Our goal is to identify and isolate a molecule that is effective against a disease target.

The Biologics and Biopharmaceutics team is responsible for the research and development of sterile & parenteral drug products for biologics as well as the biopharmaceutics support for the oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team that will build biopharmaceutics understanding of how formulation impacts exposure of compounds in humans spanning the oral and non-oral portfolio.

Responsibilities:

Develop and execute a comprehensive biopharmaceutics strategy leveraging cutting-edge in vitro, in vivo, and in silico physiologically based pharmacokinetics (PBPK) and PK modeling tools.
Collaborate in a fast-paced, integrated, multidisciplinary team environment with key stakeholders across organizations.
Proactively identify key biopharmaceutics risks at each stage of drug product development for small molecules and/or biologics.
Conduct hypothesis-based assessment employing a rigorous integrated approach.
Recruit, select, develop, and mentor talent.
Manage the departmental budget and ensure alignment with strategic goals.

Qualifications:

Ph.D. in Pharmaceutics, Pharmacokinetics, Biopharmaceutical sciences, Pharmaceutical sciences, or relevant field with a minimum of 10 years of industrial experience; or B.S. or M.S. in the same fields with a minimum of 12 years of industrial experience.

Required:

Advanced knowledge in pharmacokinetics and understanding of principles of physiologically-based pharmacokinetic modeling.
Experience with regulatory submissions including writing/review of regulatory filings including INDs and NDAs.
Strong influencing and communication skills.

Preferred Experience and Skills:

Hands-on experience with physiologically-based pharmacokinetics modeling software (e.g., Simcyp, GastroPlus).
Experience in regulatory compliance expectations across all phases of product development to commercialization.

Employee Status: Regular

Relocation: Domestic

VISA Sponsorship: No

Travel Requirements: 10%

Job Posting End Date: 11/02/2024

#J-18808-Ljbffr