Manufacturing Operations Analyst II

Position Overview

The Manufacturing Operations Analyst at Milford’s Manufacturing Operations group participates in biologics manufacturing and development processes, proactively seeks opportunities for improvement, leads investigations, and coordinates manufacturing deliverables.

• Collaborate on mitigation of Environmental, Health, and Safety (EHS) risks.
• Serve as subject‑matter expert for upstream and downstream production steps, including cell expansion, automated cell culture systems, viral inactivation, filtration, chromatography, ultrafiltration, and buffer/media preparation.
• Lead SAP improvements, training, and execution of inventory transactions for manufacturing.
• Lead event investigations, root‑cause analysis, and CAPA implementation.
• Own manufacturing‑related change control for new and existing products.
• Organize and prepare documentation and presentation materials for assigned projects.
• Monitor and review batch parameters, data entry, and quality release procedures.
• Participate in data trending programs and batch record/SOP creation.
• Coordinate personnel for daily activities in collaboration with the production team.
• Act as liaison between Manufacturing and other departments for planning and issue resolution.
• Support manufacturing team leads during processing periods.
• Participate in Continuous Improvement teams (5S, Gemba, LEAN, etc.).
• Demonstrate procedures during training sessions and lead team meetings.
• Stay current with biopharmaceutical industry best practices and technologies.

• Bachelor’s Degree or equivalent experience.
• 3+ years of related experience.
• Experience customizing SAP and knowledge of related business processes.
• Demonstrated knowledge of cGMP manufacturing and related processes.
• Experience with chromatography, cell culture, or single‑use technology.
• Knowledge of laboratory and pharmaceutical production equipment (autoclaves, process tanks, chromatography skids and columns, analytical equipment).
• Proficiency in mathematical disciplines and ability to work with metric and USA measurement systems.
• Strong written and verbal communication skills in English.
• Experience with standard troubleshooting approaches, root‑cause analysis, and corrective actions.
• Basic chemical and biological safety procedure knowledge.
• Good computer skills (Microsoft Word, Excel, quality systems).
• Effective teamwork and interpersonal skills.
• Ability to meet schedule demands, including shift, weekend, holiday work, and overtime.
• Ability to work in a clean room environment and comply with hygiene standards.

• Experience with regulatory agency interactions.

• Lab environment with occasional office duties.
• Standing 3–4 hours per day, lifting no more than 25 lbs, pushing buffer containers 50–200 L, sitting 2–3 hours during processing.
• Clean room compliance and use of special garments and personal protective equipment required.

Base Pay Range: $85,000 – $95,000