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Merck · 1 day ago

Sr. Pharmaceutical Commercialization Scientist (Engineer)

West Point, PA

Full-time

Hybrid

Mid, Senior Level

$115K/yr - $180K/yr

6+ years exp

Merck is a leading pharmaceutical company seeking a Senior Engineer / Scientist in their Pharmaceutical Commercialization Technology (PCT) department. The role focuses on pharmaceutical process and technology development for small molecule solid dosage drug products, aiming to bring new medicines to patients worldwide.

BiotechnologyHealth CareMedicalPharmaceutical

Comp. & Benefits

No H1B

Responsibilities

Plan, conduct, and interpret pharmaceutical process development studies, such as scale up, technology transfer, design space development, clinical and stability batch manufacture, and process validation

Participate in or lead drug product working groups and technology development teams and represent the department in cross-functional interactions

Apply problem-solving skills and aspects of Quality by Design, including risk-based approaches to development, design of experiments, and process modeling

Author technical documents, such as experimental protocols, reports, and regulatory filings

Demonstrate oral and written communication skills and effective collaboration and leadership within teams, including commercial sites and/or third-party vendors

Evaluate new and innovative technologies and equipment, perform physical testing and data analysis, and comply with applicable safety and current good manufacturing practices

Contribute to publications and presentations within the scientific community as appropriate

Advance innovation and digital and data analytics capabilities

Qualification

Chemical EngineeringPharmaceutical SciencesProcess DesignData AnalyticsCGMP RegulationsProcess Scale UpDesign of Experiments (DOE)Solid Oral DosageStatistical LiteracyClinical JudgmentGenerative AIAdaptabilityDetail-Oriented

Required

Bachelor's degree in Chemical/Biochemical Engineering, Materials Science/Engineering, Pharmaceutical Sciences, or related discipline and six (6) years required experience, master's degree and four (4) years required experience, or PhD with no additional experience required

Proven ability to work both independently and as part of a team and execute against commitments

Demonstrated capability to design and execute an experimental program with mechanistic understanding, process robustness, productivity, and cost in mind, and integrate efforts with specialists from other technical disciplines

Hands-on experience in a laboratory, pilot plant, or manufacturing facility

Preferred

Familiarity with concepts and application of cGMP during pharmaceutical development and production

Experience authoring the Chemistry and Manufacturing Controls (CMC) sections of New Drug Applications/Worldwide Marketing Applications (NDAs/WMAs)

Experience with Solid Oral Dosage Unit operations, particularly Spray Drying and Bilayer Compression

Experience in supporting partners in supply, including either support of process validation preparation and execution or products post-validation, or technology transfer between sites

Experience interacting with commercial sites and/or third-party vendors during development and/or clinical or supply manufacturing

Experience in pharmaceutical drug substance or drug product development or similar

Experience with process scale-up and/or technology transfer, moving between laboratory, pilot, and commercial scale

Experience with data analytics, process modeling, and/or statistical process control

Digital fluency in one or more of the following: Python, R, powerBI, power apps, Generative AI as a productivity tool, data literacy and statistical reasoning