Associate Specialist, Operations (Onsite)

About the role

The Small Scale Organics (SSO) Pilot Plant is a GMP manufacturing facility in the Small Molecule Process R&D organization. It supports scale-up of manufacturing steps, demonstration of new technologies, training and technology transfer to commercial sites. The Operations Specialist provides hands-on assistance for daily production, ensures compliance with Safety & Environmental (S&E) and current Good Manufacturing Practices (cGMP) requirements, and prepares the facility for batch processing. The position is onsite, five days a week, in Rahway, New Jersey.

Key responsibilities

• Take part in equipment setups, raw material sampling and subdivision, solution preparation, batch processing planning and execution at pilot scale, process knowledge capture and equipment troubleshooting.
• Handle reagents, solvents and active pharmaceutical ingredients during wet chemistry and dry powder processing.
• Keep processes within the facility's capability limits and ensure readiness for cleaning, batch execution, housekeeping and consumable inventory.
• Support incident root cause analysis, corrective and preventative action closures, and building improvement projects.
• Investigate safety observation reports, mentor new and rotational employees, and author lessons learned and summary reports.
• Work 8-hour shifts rotating between 1st and 2nd shift on alternating weeks, with occasional overtime.

Required profile

• Associate degree (ideally in Process Technology) or higher degree in a relevant technical field completed by December 2026; or high school diploma/GED plus at least four years of experience in pharmaceutical, chemical, petrochemical or food processing/manufacturing.
• Strong communication skills and a collaborative mindset with cross-functional teams.
• Strong mechanical aptitude.
• Proficiency in technical writing and word processing, spreadsheet, graphing and presentation software.

Preferred experience and skills

• Pilot plant or manufacturing operations experience.
• Understanding of process scale-up from laboratory to pilot scale.
• Familiarity with cGMP, Good Documentation Practices (GDP) and S&E regulations.
• Lean Six Sigma training or certification.

What we offer

• Salary range of $71,900 to $113,200 for the primary location, with eligibility for annual bonus and long-term incentives.
• Medical, dental, vision and other insurance, retirement benefits including 401(k), paid holidays, vacation and compassionate and sick days.