Scientist, Engineering Full-time

Pharmaceutical Commercialization Technology Scientist/Engineer

The Pharmaceutical Commercialization Technology (PCT) department is seeking a Scientist/Engineer based in West Point, PA or Rahway, NJ. The group sits within the Manufacturing Division and is responsible for pharmaceutical process development and supply for small molecule solid dosage drug products, delivering new and novel medicines to patients worldwide. PCT leads process and technology development as products enter Phase IIb through regulatory filings and process validation and supports supply 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 for our extensive small molecule solid dosage capabilities.

Success in this role requires communication and collaboration within teams, a growth and innovative 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 with manager and team support, such as scale up, technology transfer, design space development, clinical and stability batch manufacture, and process validation.
• Participate in drug product working groups and/or 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.
• 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.
• Support digital and data analytics initiatives and contribute to an innovative environment.

Education Minimum Requirement:

Bachelor's degree and two years related experience or master's degree and one year related experience 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.
• Strong written and oral communication skills, technical writing experience, and an interest in solving technical problems.

Preferred Experience and Skills:

• Hands-on experience in a laboratory, pilot plant, or manufacturing facility.
• Experience with process scale-up and/or technology transfer, moving between laboratory, pilot, and commercial scale.
• Familiarity with concepts and application of cGMP during pharmaceutical development and production.
• Demonstrated capability to design and execute experiments with mechanistic understanding, process robustness, productivity, and cost in mind.
• Experience with data analytics, process modeling, and/or statistical process control.

Required Skills:

Chemical Engineering, Clinical Manufacturing, Data Analysis, Design of Experiments (DOE), Detail-Oriented, Downstream Process Development, Experimentation, Good Manufacturing Practices (GMP), Independent Thinking, Interdisciplinary Collaboration, Pharmaceutical Process Development, Process Development (PD), Process Innovation, Process Scale Up, Process Transfers, Process Verification, Product Formulation, Scientific Literacy, Scientific Presentations, Scientific Writing, Technical Evaluation, Technical Reviews, Technical Writing, Technology Development

The salary range for this role is $87,300.00 – $137,400.00. 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.