Assoc. Spclst, Prep Lab Operations Specialist (Onsite)
Merck & Co.
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Benefits offered by this job
Job summary
Merck & Co. Rahway, NJ is seeking an Associate Specialist for Prep Lab Operations to support API/DS manufacturing for development and clinical studies. You will work with scientists and project teams, ensuring GMP readiness and interfacing with cross-functional partners in a fast-paced environment.
The role requires onsite presence five days a week, strong mechanical aptitude, and experience with GMP documentation and SOPs. A Bachelor’s or equivalent plus relevant experience is expected.
Qualifications
- Bachelor's degree or equivalent with related work experience.
- Experience in GMP/good manufacturing environments preferred.
- Strong mechanical aptitude and problem-solving ability.
- Excellent written and verbal communication; able to work cross-functionally.
Responsibilities
- Support Prep Lab operations for API and Drug Substance manufacturing at kg scale.
- Collaborate with teams to understand equipment needs and ensure GMP readiness.
- Work with Safety and Quality to maintain regulatory compliance.
- Lead process-improvement initiatives to enhance efficiency.
Skills
Education
Job description
The Enabling Facilities (EF) group within the Chemical Engineering Research & Development (CERD) Department is seeking a highly motivated individual to work in a fast-paced job that provides operations experience and a strong understanding of engineering fundamentals. The Associate Specialist - Prep Lab Operations position will report to the Director, Engineering and will be a member of the EF Team at the Rahway, NJ facility. This position will be a member of the Prep Lab team which is responsible for interfacing with scientists and Project teams who are manufacturing API (Active Pharmaceutical Intermediates) and DS (drug substance) to enable early clinical studies, scaling up new chemistries, and exploring new technologies.
- The Associate Specialist - Operations role involves working directly with the Prep Lab lead supporting scientific teams who are preparing for manufacturing API and DS to supply material for both development work and clinical studies in our kg scale (Prep Lab) facilities.
- This work involves collaborating with teams to understand their equipment and processing needs, supporting them during manufacture if required, and ensuring that the facility is kept GMP ready at all times.
- The Associate Specialist will also be expected to work with Safety and Quality partners to ensure that the facility is compliant with all applicable regulations.
- And the successful candidate will lead process improvement initiatives to enhance the efficiency and effectiveness of the overall Prep Lab operations.
As required by the business and in addition to support of the Prep Lab facility, the Associate Specialist will provide direct support of other areas of Chemical Engineering Research & Development such as:
- Modality Agnostic Chemistry Scaleup (MACS): The MACS Center is a new potent, multi-modality (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing pilot plant currently under construction in Rahway, New Jersey. Like the SSO, MACS is a GMP facility in the PR&D organization and shares its mission with the SSO but is focused on potent, cross-modality processing.
- Small Scale Organics Pilot Plant (SSO): The SSO is a Good Manufacturing Practice (GMP) manufacturing facility in the Process Research and Development (PR&D) organization. The pilot plant's mission is to serve as PR&D's internal node for small molecule drug substance clinical manufacture, and as preferred site for first pilot of commercial small molecule processes, enabling gain of critical internal experience with scale-up of manufacturing GMP steps, demonstration of new manufacturing technology/processes, training opportunities for improved manufacturing process development and seamless tech transfer to commercial sites.
- Bachelor's degree in Chemical Engineering, Chemistry, Biology, Pharmaceutical Sciences or related scientific or technical field plus one (1) year relevant work experience
- OR Associate in Science, Associate in Applied Science (ideally in Process Technology), or Associate degree in a relevant technical field of study plus at least six (6) years' experience
- OR High School Diploma/GED plus at least eight (8) years of relevant experience in Pharmaceutical, Chemical, Petrochemical, Food Processing, or Manufacturing.
- Effective interpersonal and communication skills, both verbal and written.
- Excellent organizational skills to multi-task.
- Desire and willingness to learn, contribute and lead.
- Track-record of independent problem-solving.
- Strong communication skills to discuss technical problems and a collaborative mindset to interface with cross-functional teams.
- A strong mechanical aptitude.
- Proficiency in technical writing and the use of word processing, spreadsheet, graphing, and presentation software.
- Onsite presence is required five days a week.
- This role will require working on 8-hour shifts that may occasionally be 2nd shift to support batch processing.
- Occasional overtime work may be required based on business needs.
- Experience working in a GMP clinical or manufacturing supply facility.
- Experience with small molecule drug substance and/or biologics process development.
- Experience in supporting compliance investigations and change management.
- Ability to prepare or leverage Standard Operating Procedures (SOP) and cGMP documents.
- Experience operating/maintaining pilot scale or prep lab scale equipment.
- Experience with Potent Compound processing and containment systems (e.g., isolators), and/or clean room facilities.
- Operations experience in pilot plant or manufacturing environment.
- Familiarity with the administration of cGMPs, Good Documentation Practices (GDPs), and S&E regulations as it pertains to pharmaceutical development.
- Lean Six Sigma Training / Certification.
- Equipment Maintenance
- Good Manufacturing Practices (GMP)
- Manufacturing Technologies
- Multitasking
- Process Optimization
- Spreadsheets
- Teamwork
- Experience working in a GMP clinical or manufacturing supply facility.
- Experience with small molecule drug substance and/or biologics process development.
- Experience in supporting compliance investigations and change management.
- Ability to prepare or leverage Standard Operating Procedures (SOP) and cGMP documents.
- Experience operating/maintaining pilot scale or prep lab scale equipment.
- Experience with Potent Compound processing and containment systems (e.g., isolators), and/or clean room facilities.
- Operations experience in pilot plant or manufacturing environment.
- Familiarity with the administration of cGMPs, Good Documentation Practices (GDPs), and S&E regulations as it pertains to pharmaceutical development.
- Lean Six Sigma Training / Certification.
We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance.
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.
Regular
No relocation
No
No Travel Required
Not Applicable
Not Indicated
No
n/a
09/3/2026
R413906
$71,900.00 - $113,200.00
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.
- Medical, dental, vision healthcare and other insurance benefits for employee and family
- Retirement benefits including 401(k)
- Paid holidays
- Vacation
- Compassionate and sick days
- Comprehensive package of benefits as described at https://jobs.merck.com/us/en/compensation-and-benefits.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
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