Job Description

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 ascontract 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.

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:

Bachelors degree and 6 years related experience, masters 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:

Preferred Skills:

Current Employees apply

Current Contingent Workers apply

US and Puerto Rico Residents Only:

The salary range for this role is

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 employees 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 .

You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

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