Job Description

• Lead process R&D for late‑stage clinical and commercial active ingredients, developing robust synthetic routes in the lab and preparing processes for scale‑up and regulatory filing.
• Support Phase III process development and the commercial launch and continuous supply of new products.
• Conduct initial development of new chemistries/technologies for commercial processes and deliver practical, scalable solutions.
• Provide dynamic on‑site and off‑site manufacturing support: process maintenance, troubleshooting, real‑time deviation assessment and documentation.
• Drive and document process improvements via Change Control; support process validation and produce validation documentation.
• Define and document efficient cleaning procedures and produce cleaning technical assessments for new products.
• Support technology transfers to partner sites, supplying technical chemistry expertise and transfer documentation.
• Apply Lean Six Sigma tools (Kaizen, etc.) to resolve process issues and contribute to small improvement/maintenance projects.
• Prepare and author required documentation and milestone reports for plant operations, tech transfers and regulatory submissions.
• Present technical findings internally and collaborate with cross‑functional commercialization partners (CERD/CCTO, Pharm, Process Research, Operations).

• PhD in Chemistry, Chemical Engineering or a closely related discipline.
• Experience in the pharmaceutical industry or advanced research in a relevant chemistry area is a strong advantage.
• Strong hands‑on laboratory skills and experience developing or scaling synthetic routes.
• Practical experience supporting process transfers, validation activities and manufacturing troubleshooting.
• Good knowledge of GMP principles, safety and laboratory waste/risk assessment procedures.
• Ability to interpret analytical and process data and communicate technical conclusions clearly.
• Experience with documentation for regulatory filings (e.g., IND/NDA/MAA) is desirable.
• Comfortable working in cross‑functional teams and presenting technical material to diverse audiences.

• Make a tangible impact on product launches that improve patient lives.
• Collaborate with world‑class scientists and commercialization teams in an innovative, supportive environment.
• Opportunities to work on new chemistries and scale cutting‑edge technologies to commercial production.
• Professional development, training on GMP and Lean Six Sigma, and career progression in a growing organization.

Current Employees apply HERE

Current Contingent Workers apply HERE

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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Required Skills:

Analytical Instrumentation, Analytical Method Development, Analytical Problem Solving, Analytical Testing, Antibody Drug Conjugates (ADC), Chemistry Techniques, Data Analysis, Detail-Oriented, Lab Equipment Maintenance, Laboratory Maintenance, Laboratory Safety, Liquid Chromatography-Mass Spectrometry (LC-MS), New Product Introduction Process, Organic Synthesis, Pharmaceutical Research, Preparative Chromatography, Process Management, Production Process Development, Purification Methods, Reverse Phase Chromatography

Preferred Skills:

Job Posting End Date:

09/19/2025

*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.