Associate Specialist, Operations (onsite)

Merck Merck · Pharma · NJ

The Associate Specialist, Operations role at Merck is focused on hands-on assistance for daily production activities in a GMP manufacturing facility. This includes equipment setups, raw material sampling, solution preparations, batch processing, and troubleshooting, all while ensuring compliance with Safety & Environmental and cGMP requirements. The role supports process development, technology development, and the supply of Active Pharmaceutical Ingredient (API) for clinical use. It involves both wet chemistry and dry powder processing, with a primary focus on executing batch production work and contributing to facility improvement activities.

What you'd actually do

  1. Under the scientific direction of a facility lead, the Operations Specialist will participate in equipment setups, raw material sampling and subdivisions, solution preparations, batch processing planning and execution at a pilot scale, process knowledge capture, and troubleshooting equipment with the aim of advancing process development, aiding technology development, and supplying Active Pharmaceutical Ingredient (API) for clinical use and drug product development.
  2. Ensure processes are run within the capability constraints of the facility.
  3. Ensure facility readiness with respect to cleaning (including documentation and execution), batch execution, building housekeeping, and consumable inventory.
  4. Provide input for incident root cause analysis, reporting, and action items.
  5. Facilitate and drive building improvement projects and corrective/preventative action closures.

Skills

Required

  • 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.
  • This role requires working on 8-hour shifts that rotate between 1st and 2nd shift on alternating weeks throughout the year.
  • Onsite presence is required five days a week.
  • Occasional overtime work may be required based on business needs.

Nice to have

  • Operations experience in pilot plant or manufacturing environment.
  • Understanding of/Experience with process scale-up of chemical processes, moving from the laboratory to the pilot scale.
  • 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.

What the JD emphasized

  • GMP (Good Manufacturing Practices)
  • cGMPs
  • Safety & Environmental (S&E)