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

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

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The primary location for this posting is:

USA - Pennsylvania - West Point

Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is:

$71,900.00 - $113,200.00

This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and 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

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

No relocation

VISA 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.