Job Description
Are you a PhD chemist ready to translate cutting‑edge research into life‑changing medicines? Join our dynamic chemistry team and play a central role in developing, scaling and launching Phase III and commercial drug substances. You'll collaborate with leading scientists across our labs and U.S. research & commercialization sites, apply new chemistries and technologies, and provide hands‑on technical support to manufacturing.
What you'll do
* 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).
What We're Looking For
* 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.
Why join us
* 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 PM 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.
Requisition ID
R362788