Merck · 1 day ago
Principal Scientist, Sterile Product Development
USA - New Jersey - Rahway
Full-time
Hybrid
Lead/Staff
$173K/yr - $273K/yr
8+ years expMerck is a leading global healthcare company, and they are seeking a Principal Scientist in Sterile Product Development. This role involves designing and developing sterile products for various routes of administration while providing strategic and technical leadership to development teams and ensuring adherence to regulatory standards.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Be a seasoned biologics product developer responsible for designing and developing sterile products for injectable, ophthalmic, and inhaled routes of administration
Support both early and late-stage development candidates that will include ensuring screening and development of robust drug product composition, scalable process, primary packaging, compatibility characterization for processing and administration, and supporting regulatory filings
Have deep fundamental knowledge around large molecule drug product development and have management responsibilities for a small group of scientists during product development to ensure completion of key milestones and laboratory / regulatory documentation
Active strategic and technical leadership on program development teams, interfacing with key stakeholders, and collaborating across functions to drive defined milestones will be required
Responsible for ideating, leading, and championing organizational strategic and innovation objectives aligned with organizational goals
Has prior experience with process scale up, modeling, regulatory filings and/or driving key capability evaluation/ build
Be willing to take initiative, motivated to excel, have a strong technical background, have excellent communication and interpersonal skills, ability to multi-task, mentor scientists, and a strong desire to learn and contribute
Proven demonstration of leadership behaviors
Qualification
Required
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
The candidate should have a strong track record in biologics product development/ regulatory filing/ drug delivery/ complex formulation and process development (including mAbs, ADCs, fusion proteins, combinations such as doublet or triplet co-formulations and drying technologies such as lyophilization) reflected through industry experience and external publications and patents
The candidate should have experience in designing and executing appropriate DOE studies to inform on biologic drug product risks such as oxidation or light exposure
The candidate should have experience in QbD principles and experience applying the QbD tools and principles to drug products in development
The candidate should have experience authoring regulatory filings for sterile dosage forms especially biologics (liquid/ lyophilized/ complex systems)
The candidate should have experience with technology transfer to facilitate scale-up of early phase and late phase biologic drug product manufacturing processes to GMP production facilities
The candidate should have strong familiarity with relevant biologic analytical methods and specifications for drug products as well as drug substance downstream formulation considerations
The candidate should have experience in developing combination products for biologic therapeutics
The candidate should have experience, desire and a track record of effective mentorship of junior scientists towards timebound goals
The candidate should demonstrate scientific leadership in the field of biologics product development
Preferred
Experience in pharmaceutical sciences, physical pharmacy, physiology, pharmacokinetics, biochemistry, protein sciences, chemical kinetics or transport phenomenon is highly desirable
Experience in biologics process development and process characterization to enable efficient tech transfer to manufacturing sites
Experience in modeling such as Monte Carlo simulations to predict manufacturing success
Experience in formulation/process, definition of critical attributes for process scale-up, analytical development and experience with Biologics License Application filing for non-conventional sterile dosage forms including ocular dosage forms or peptide therapeutics, and/or alternate delivery technologies (e.g. high concentration, hydrogels, emulsions, suspensions, injectable depot) is a plus
Benefits
Medical
Dental
Vision healthcare
Other insurance benefits (for employee and family)
Retirement benefits, including 401(k)
Paid holidays
Vacation
Compassionate and sick days
Company
Merck
Merck is a biopharmaceutical company that offers medicines and vaccines for various diseases.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$5.59MKey Investors
Private Capital AdvisorsGavi, the Vaccine Alliance
2018-11-25Post Ipo Equity· $0.59M
2016-01-21Series Unknown· $5M
1980-12-19IPO
Leadership Team
Betty Larson
Executive Vice President and Chief Human Resources Officer
Dean Li
Executive Vice President and President, Merck Research Laboratories
Recent News
2026-01-24
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