Biologics Product Development Manager

7 days ago


Rahway, New Jersey, United States Merck Sharp & Dohme Full time

About the Role

As a Principal Scientist (R5) in our Biologics product development team, you will be responsible for designing and developing sterile products for injectable, ophthalmic, and inhaled routes of administration. You will work closely with cross-functional teams to ensure timely completion of key milestones and laboratory/regulatory documentation. This role requires a strong technical background, excellent communication and interpersonal skills, and the ability to multi-task and mentor junior scientists.

Key Responsibilities

  • Design and develop sterile products for injectable, ophthalmic, and inhaled routes of administration.
  • Support early and late-stage development candidates, ensuring robust composition, primary packaging/device, and process selection through deep fundamental understanding and characterization.
  • Author regulatory filings for sterile dosage forms, especially biologics.
  • Mentor junior scientists and provide guidance on biologics product development.

Requirements

  • Masters with a minimum of 12 years or Ph.D. with a minimum of 8 years of industry experience and a Degree in Chemical/Biomedical Engineering, Pharmaceutics, Pharmaceutical Chemistry, Pharmaceutical Sciences, Chemistry, Biochemistry, or related field.
  • Strong knowledge of biologics product development, regulatory filing, drug delivery, complex formulation, and process development.
  • Experience in designing and executing appropriate DOE studies to inform on biologic drug product risks such as oxidation or light exposure.
  • Familiarity with QbD principles and experience applying the QbD tools and principles to drug products in development.

What We Offer

  • A competitive salary range of $120,000 - $150,000 per year.
  • A comprehensive benefits package, including medical, dental, and vision insurance.
  • A 401(k) plan with company match.
  • Generous paid time off and holidays.
  • Professional development opportunities.


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