Associate Scientist Engineering

MSD; West Point (PA); Hybrid; USD 72,000 - 113,000; Full time

Benefits offered by this job

Medical

Dental

Vision healthcare

Retirement benefits

401(k)

Paid holidays

Vacation

Compassionate and sick days

Job summary

MSD in the United States (PA—West Point) is seeking an Associate Scientist to join the Sterile Drug Product Commercialization (SDPC) team. You will support cross-functional groups from process development through PPQ and regulatory filing, and you will design and execute DP commercialization studies to advance late-stage and commercial products.

You will develop technical documents, contribute to scale-down models, and help ensure programs meet science, quality, safety, and cost requirements

Qualifications

• Bachelor-level or higher in a chemical/biochemical field.
• Strong communication skills, both oral and written.
• Ability to explain process science to a multidisciplinary 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 including process design, qualification, and validation.
• Contribute to scale-down model development and ensure programs meet safety, quality, and cost targets.

Skills

Adaptability

Data Analysis

Experimentation

Laboratory Techniques

Manufacturing

Process Development

Process Engineering

Technology Transfer

Education

B.S. or higher in Chemical Engineering or related field

Job description

Associate Scientist - Sterile Drug Product Commercialization (SDPC)

At our company, we aspire to be the premier research-intensive biopharmaceutical company. We're at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals.

The Associate Scientist in this position will be part of the Vaccines team within Sterile Drug Product Commercialization.

As part of our manufacturing division, the Sterile Drug Product Commercialization (SDPC) group provides the technical process leadership and laboratory capabilities for late-stage and commercial drug product processes for vaccines, biologics, and sterile pharmaceutical products. It is responsible for commercialization activities including process development, process scale up, technology transfer to internal and external sites, process validation, authoring of regulatory submissions and support of significant manufacturing investigations. The group is responsible for establishing the science, engineering and knowledge required for today’s innovative and accelerated commercialization of novel vaccines, biologics, and pharmaceutical products.

Sterile Drug Product Commercialization is part of the larger Global Science, Engineering, and Commercialization organization. With our extensive range of facilities and environments, our scientists and engineers have career opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.

Responsibilities

• Support cross-functional DP working groups from process development through Process Performance Qualification (PPQ) and regulatory filing. Examples include registration stability study execution, process characterization study planning and execution, technology transfer control strategy, process development, PPQ readiness, Pre-Approval Inspection (PAI) support, launch and post-launch support.
• Designs, authors, and executes DP commercialization studies.
• Develops and authors technical documents including process design, definition, qualification, and validation.
• Contributes to development of fit-for-purpose scale-down models.
• Ensures commercialization programs meet requirements related to science, quality, reliability, safety, schedule and cost.
• Innovates and drives best practices for commercial site tech transfer, facility fit and development of the DP control strategy. Includes the classification of process parameters, performance parameters, operating ranges, and in-process controls.
• Manages project work to ensure due dates are met, escalating when necessary and developing remediation plans.
• Contributes to a culture of safety, high performance, out-of-the-box thinking, innovation, continuous learning, empowerment, diversity and inclusion.
• This position may require travel up to 10% ; must be able to travel for this position.
• This position is required to be on-site four days per week.

Qualifications

Required

• B.S. or higher degree in Chemical Engineering, Biochemical Engineering, Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field
• Excellent oral and written communication skills.
• Ability to effectively articulate understanding of process science to drive decision making in a multi-disciplinary team environment.

Preferred

• Technical experience in large molecule drug product process characterization, fill finish process optimization, scale-up and technology transfer of sterile products to pilot/commercial.
• Knowledge of combination product development.
• Working knowledge of regulatory requirements or current Good Manufacturing Practices (cGMPs) for manufacturing of sterile dosage forms and current ICH Quality norms, as applied in Manufacturing Science and Technology or Technical Operations.
• Working knowledge of statistical methods for DOE design and data analysis, statistical process control (SPC), multivariate analysis (MVA), and/or process analytical technologies (PAT) techniques for manufacturing processes.
• Working understanding of analytical methods to characterize vaccines and other sterile drug products.

Required Skills

Adaptability, Data Analysis, Experimentation, Laboratory Techniques, Manufacturing, Process Capability Analysis, Process Definition, Process Design, Process Development (PD), Process Engineering, Product Formulation, Statistical Data Analysis, Technical Reviews, Technical Writing, Technology Transfer, Timeline Management, Writing Technical Documents

Primary Location

USA - Pennsylvania - West Point

Salary Range

$71,900.00 - $113,200.00

Benefits

• Medical
• Dental
• Vision healthcare
• Other insurance benefits (for employee and family)
• Retirement benefits
• 401(k)
• Paid holidays
• Vacation
• Compassionate and sick days

More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

Additional Location(s)

Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

Additional Location(s) Compensation Information

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Employee Status

Regular

Relocation

No relocation

VIS Sponsorship

No

Travel Requirements

25%

Flexible Work Arrangements

Hybrid

Shift

1st - Day

Valid Driving License

No

Hazardous Material(s)

Yes

Job Posting End Date

10/23/2026* A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.