Associate Specialist, Operations; Onsite

Job Description

The Small Scale Organics (SSO) Pilot Plant is a GMP (Good Manufacturing Practices) manufacturing facility within the Small Molecule Process Research and Development (SM PR&D) organization. It provides critical internal experience with scale‑up of manufacturing GMP steps, demonstration of new manufacturing technology/processes, training opportunities for process development, and seamless technology transfer to commercial sites.

The SSO Operations Specialist assists with daily production activities while ensuring compliance with Safety & Environmental (S&E) and current Good Manufacturing Practices (cGMP) requirements. The role implements actions to meet S&E and GMP requirements, maintains facility readiness for batch processing, and supports overall building performance. The specialist works cooperatively with the SSO leadership team and partners to drive success and performance of the building and support the SM PR&D pipeline.

• Under the scientific direction of a facility lead, 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 to advance process development, aid technology development, and supply Active Pharmaceutical Ingredient (API) for clinical use and drug product development.
• Ensure processes are run within facility capability constraints.
• Maintain facility readiness for cleaning (documentation and execution), batch execution, building housekeeping, and consumable inventory.
• Provide input for incident root cause analysis, reporting, and action items.
• Facilitate and drive building improvement projects and corrective/preventative action closures.
• Provide input on process setups.
• Offer regular feedback to peers to promote a continuous improvement mindset.
• Collaborate with all building staff to share and align best practices.
• Investigate problem statements and safety observation reports (SORs) to promote fast and efficient closure.
• Safely perform high‑risk work involving hazardous energy control when needed.
• Identify and follow through on opportunities to improve building flexibility, efficiency, compliance, and safety.
• Author lessons learned and summary reports to capture gained knowledge.
• Mentor and help train rotational and new employees.
• Primary focus is executing batch production work; additional responsibilities include coordination, planning, documentation, and other facility‑improvement activities.

• Associate in Science or Associate in Applied Science (ideally in Process Technology), or a higher degree in a relevant technical field, with expected completion by June 2026.
• Or High School Diploma/GED plus at least four (4) years of relevant experience in Pharmaceutical, Chemical, Petrochemical, or Food Processing/Manufacturing.

• 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.
• Experience working on 8‑hour shifts that rotate between 1st and 2nd shift on alternating weeks throughout the year; onsite presence required five days a week with occasional overtime as needed.

• Operations experience in a pilot plant or manufacturing environment.
• Understanding of/experience with process scale‑up of chemical processes from laboratory to pilot scale.
• Familiarity with the administration of cGMPs, Good Documentation Practices (GDP), and S&E regulations as they pertain to pharmaceutical development.
• Lean Six Sigma training or certification.

Shift: 1st – Day, 2nd – Evening. Relocation:
No. Visa Sponsorship:
No.

Travel Required:

No. Flexible Work Arrangements:
Not applicable.

Salary range: $71,900.00 – $ (based on education, qualifications, experience, skills, location, and business needs). Eligible for annual bonus and long‑term incentive, if applicable. Benefits include medical, dental, vision, retirement (401(k)), paid holidays, vacation, and compassionate/sick days.

US and Puerto Rico Residents only. Our company is committed to inclusion and provides accommodations during the application or hiring process. As an Equal Employment Opportunity Employer, we prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other legally protected characteristics. We comply with federal affirmative action requirements for protected veterans and individuals with disabilities.

Job posting end date: 07/23/2026 (effective until 11:59:59 PM on the day before the listed end date).