Associate Specialist - Modality Agnostic Chemistry Scaleup Operations Specialist

Merck KGaA Darmstadt Germany • Rahway, NJ

443d • $68,400 - $107,700 • Onsite

About The Position

The Associate Specialist - Modality Agnostic Chemistry Scaleup Operations Specialist will be part of the Enabling Facilities group within the Chemical Engineering Research & Development Department. This role focuses on supporting the Modality Agnostic Chemistry Scaleup (MACS) Center, which is a new facility for drug substance development and GMP clinical manufacturing. The position involves contributing to equipment and facility design, system commissioning, and supporting operations to ensure the quality and safe delivery of clinical supplies. The candidate will work closely with engineers, chemists, and compliance representatives in a collaborative environment.

Requirements

• Bachelor's degree in Chemical Engineering, Chemistry, Biology, Pharmaceutical Sciences, or related field; or an Associate degree with relevant experience; or a High School Diploma with four years of relevant experience.
• Effective interpersonal and communication skills, both verbal and written.
• Excellent organizational skills to manage multiple tasks.
• Desire and willingness to learn, contribute, and lead.
• Track record of independent problem-solving.
• Strong mechanical aptitude and proficiency in technical writing and software tools.

Nice To Haves

• Experience working in a GMP clinical or manufacturing supply facility.
• Experience with GMP facility design, equipment start-up, and qualification.
• Experience with small molecule drug substance and/or biologics process development.
• Experience in supporting compliance investigations and change management.
• Familiarity with cGMPs, Good Documentation Practices, and S&E regulations.
• Lean Six Sigma Training / Certification.

Responsibilities

• Support the Modality Agnostic Chemistry Scaleup (MACS) Center during its Detail Design Phase.
• Contribute to equipment and facility design, system commissioning, and qualification activities.
• Collaborate with development engineers, chemists, and compliance representatives to ensure quality and safety in clinical supply delivery.
• Assist in equipment setups, raw material sampling, solution preparations, and batch processing planning and execution at pilot scale.
• Handle various reagents, solvents, and active pharmaceutical ingredients during wet chemistry operations and dry powder processing.
• Provide support to other areas such as the Small Scale Organics Pilot Plant and Prep Lab as needed.

Benefits

• Bonus eligibility
• Long-term incentive if applicable
• Health care and other insurance benefits for employee and family
• Retirement benefits
• Paid holidays
• Vacation
• Sick days

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Chemical Manufacturing
• Education Level: High school or GED