Senior Scientist, Engineering Full-time

Senior Engineer Pharmaceutical Commercialization Technology

The Pharmaceutical Commercialization Technology (PCT) department is seeking a Senior Engineer based in Rahway, NJ. The group sits within the Manufacturing Division and is responsible for pharmaceutical process and technology development for small molecule solid dosage drug products, bringing new and novel medicines to patients worldwide. PCT leads process development as products enter Phase IIb through regulatory filings, process validation, and for several years beyond commercial launch. Products are commercialized at a network of internal manufacturing sites, located in Ireland and Singapore, as well as contract manufacturing organizations around the world. Coupled with development centers in Rahway, NJ and West Point, PA, these sites are the foundation of our extensive small molecule solid dosage development and commercialization capabilities.

Success in this role requires strong communication and collaboration within teams, a growth mindset and eagerness for continuous learning, a passion for science and solving technical problems, and hands-on development and manufacturing from pilot to commercial scale. Partners include research and development, analytical, regulatory, quality, packaging, and operations at our commercialization and commercial supply sites. We recognize that the diversity in our team is our strength and are dedicated to creating an inclusive environment for all employees.

Key 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.

Education Minimum Requirement:

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

Required Experience and Skills:

• 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.
• Experience with process scale-up and/or technology transfer, moving between laboratory, pilot, and commercial scale.
• Hands-on experience in a laboratory, pilot plant, or manufacturing facility.

Preferred Experience and Skills:

• 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 one or more of the following: (1) Analytical tools for analyzing big data and process performance, (2) Development, application, or validation of process models, (3) Development or application of statistical process control techniques, and/or (4) Knowledge and use of statistical techniques as applied to product sampling and release.
• Experience in supporting partners in supply, including either support of process validation preparation and execution or products post-validation.
• 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.

Required Skills:

cGMP Regulations, Chemical Engineering, Chemistry, Chromatographic Techniques, Clinical Judgment, Commercialization, Design of Experiments (DOE), Good Manufacturing Practices (GMP), Pharmaceutical Industry, Pharmaceutical Research, Process Development (PD), Process Optimization, Process Scale Up, Process Transfers, Scientific Presentations, Scientific Writing, Small Molecule Synthesis, Strategic Planning, Technical Evaluation, Technical Reviews, Technology Transfer, Writing Technical Documents

Preferred Skills:

The salary range for this role is $117,000.00 – $184,200.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this 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.