Lead Operator - Peptide Synthesis

Role Summary

Lead Operator for API manufacturing operations responsible for the production of API molecules with a safety-first, quality-always mindset in a GMP startup environment.

Responsibilities

• Maintain compliance with all regulatory requirements at all times.
• Support the execution of the production plan for the site.
• Carry out daily monitoring testing and cleaning duties to ensure equipment and systems are in good operating condition and maintained in accordance with local and corporate regulatory requirements.
• Enter Trackwise events, participate in and lead CAPA investigations.
• Troubleshoot and diagnose process problems and take appropriate actions to minimize deviations or site impact.
• Understand Health, Safety & Environmental-regulated environment and apply Health & Safety/Process Safety standards to execute key/critical GMP duties.
• Understand other area processes and their operational hazards and react appropriately.
• Monitor and collect data on equipment use and performance to anticipate potential equipment reliability problems.
• Work with Maintenance and Technical Support to respond to potential utility supply upsets or equipment failure.
• Contact the appropriate help if there is a problem or an event during processing.
• Communicate to other shifts regarding status of area operations and issues at handover.
• Participate in building and area operations such as safety audits, procedure coordination, housekeeping and improvement projects.
• Be trained and qualified on all specified unit operations within the building.
• Identify concerns for informal or formal discussion (shift meetings, safety representative).
• Know and follow cGMP practices, safe work habits, hygiene standards, and housekeeping requirements.

Qualifications

• High School Diploma or equivalent
• Legally authorized to work in the United States; no visa sponsorship expected
• Completion of Post Offer Exam or Work Simulation if applicable
• Effective communication (electronic, written, and verbal)
• Basic computer skills (desktop software)
• Minimum 3 years previous experience in operations

Additional Preferences

• Experience in facility/area start-up environments
• Experience in pharmaceutical manufacturing with PSM-regulated/hazardous chemicals
• Ability to lead and prioritize daily tasks without direct supervision
• Understanding of FDA guidelines and cGMP requirements
• Strong organizational skills and ability to handle multiple requests
• Knowledge of lean manufacturing principles
• Flexibility to troubleshoot and triage challenges
• Ability to understand technical nomenclature and mathematical formulas
• Manual material handling as appropriate
• Physical ability to bend, reach, stretch, climb ladders, and work in tight spaces; stand for long periods

Additional Information

• Ability to work rotating 12-hour day or night shifts
• Ability to work flexible schedules during startup period and overtime as required