Sterile Vaccine Process Scientist Tech Transfer & Scale-Up

MSD; Upper Gwynedd Township (Montgomery County); Hybrid; USD 72,000 - 113,000; Full time

Job summary

MSD in USA - Pennsylvania - West Point is seeking an Associate Scientist for Sterile Drug Product Commercialization (SDPC) within the Vaccines team. The role will support cross-functional groups through Process Performance Qualification and regulatory filings, and contribute to process design, validation and technology transfer.

The Associate Scientist will help develop scale-down models, ensure program quality, safety and cost targets, and travel up to 10%.

Qualifications

• B.S. or higher in chemical/biochemical engineering, bio-engineering, pharmaceuticals, biochemistry or microbiology.
• Excellent oral and written communication skills.
• Ability to articulate understanding of process science to drive decisions in a multi-disciplinary team.

Responsibilities

• Support cross-functional DP working groups from development through PPQ and regulatory filing.
• Design, author, and execute DP commercialization studies.
• Develop and author technical documents for process design, qualification, and validation.
• Contributes to development of fit-for-purpose scale-down models.
• Ensure programs meet science, quality, reliability, safety, schedule and cost.
• Drive best practices for tech transfer and DP control strategy.
• Travel up to 10% and on-site four days per week.

Skills

Adaptability

Data Analysis

Experimentation

Laboratory Techniques

Manufacturing

Process Capability Analysis

Process Definition

Process Design

Process Development

Process Engineering

Product Formulation

Statistical Data Analysis

Technical Reviews

Technical Writing

Technology Transfer

Timeline Management

Writing Technical Documents

Education

B.S. or higher in Chemical Engineering

Biochemical Engineering

Bio-engineering

Pharmaceuticals

Biochemistry

Microbiology

Job description

MSD in USA - Pennsylvania - West Point is seeking an Associate Scientist for Sterile Drug Product Commercialization (SDPC) within the Vaccines team. The role will support cross-functional groups through Process Performance Qualification and regulatory filings, and contribute to process design, validation and technology transfer.

The Associate Scientist will help develop scale-down models, ensure program quality, safety and cost targets, and travel up to 10%.