Associate Principal Scientist, Vaccine Drug Product Development

Merck; Lansdale (Montgomery County); Hybrid; USD 80,000 - 130,000; Full time

Job summary

An established industry player is seeking an Associate Principal Scientist to lead innovative vaccine drug product development. This role involves designing and executing experiments to create stable formulations and robust manufacturing processes, ensuring the translation of preclinical candidates into commercial products. The ideal candidate will possess a Ph.D. and have significant experience in laboratory settings, GMP manufacturing, and regulatory interactions. Join a team dedicated to improving global health through cutting-edge vaccine technology and enjoy a dynamic work environment that fosters collaboration and innovation.

Qualifications

• Ph.D. with 4+ years of industrial experience required.
• Hands-on laboratory skills in vaccine adjuvant development.

Responsibilities

• Design and execute experiments for stable formulations.
• Scale-up processes for pilot plant and commercial manufacturing.

Skills

Laboratory Skills in Vaccine Development

Leadership Skills

Problem-Solving Skills

Communication Skills

Education

Ph.D. in Relevant Discipline

Tools

GMP Manufacturing

Process Scale-Up

Regulatory Guidelines Knowledge

Job description

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Job Description

Vaccine Drug Product Development (VDPD), a part of our company's Research Laboratories, is seeking an Associate Principal Scientist to join our department in West Point, PA. Our mission is to develop novel vaccine drug products that will profoundly improve global human health—directly building from our company's 50+ year legacy as pioneers in the discovery, development, and manufacturing of novel vaccines to eliminate disease. Our department is responsible for developing vaccine adjuvants and drug products from preclinical studies through Phase III clinical trials with line of sight to commercialization. We ensure robust composition, primary packaging, and process development through deep fundamental understanding and characterization such that the process is scalable without compromising safety, efficacy, or stability. During development, we leverage smart experimental design, cutting edge analytical tools, and statistical/predictive approaches to inform formulation and process development. Our team enables the translation of vaccine preclinical candidates from concepts into robust commercial drug products.

Primary Responsibilities

1. Design, execution, and documentation of experiments to develop stable formulations and robust manufacturing processes for preclinical and clinical supply production.
2. Scale-up of processes to pilot plant and commercial manufacturing.
3. Work independently in a hands-on, dynamic laboratory environment while collaborating across teams and external partners.
4. Provide active strategic and technical leadership on program development teams.
5. Communicate data and conclusions clearly through reports and presentations.
6. Support or lead teams to advance science and technology innovation, business process improvements, and manufacturing capabilities.
7. Mentor less experienced scientists and contribute to external scientific networks.

Required Experience and Skills

• Ph.D. in relevant discipline with 4+ years of industrial experience, or equivalent qualifications.
• Proven communication and leadership skills.
• Hands-on laboratory skills in vaccine adjuvant or drug product process development.
• Experience with GMP manufacturing, process scale-up, and regulatory interactions.
• Strong problem-solving and process development skills.
• Ability to work independently and collaboratively.

Desired Experience and Skills

• Experience with sterile manufacturing, colloidal systems, QbD principles, and process modeling.
• Knowledge of regulatory guidelines and experience with aseptic processing.
• People management experience preferred.

Additional details include application procedures, company commitments to diversity, hybrid work model, and legal notices, which should be formatted clearly for readability.