Lead Chemical Operator - Peptide Synthesis

Role Summary

The Lead Chemical Operator - Peptide Synthesis is responsible for the production of API molecules, upholding a safety-first, quality-always mindset while running a production process with diverse unit operations. They will contribute to startup and GMP manufacturing readiness at a greenfield site, collaborating across functions to build processes and the site culture.

• 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 as assigned on the above listed systems to ensure equipment and systems are in good operating conditions and they are 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 application of Health & Safety/Process Safety standards in order to execute key/critical GMP duties.
• Understand other area processes & their operational hazards and being able to react appropriately.
• Monitor and collect data on equipment use and performance i.e. trying to anticipate potential equipment reliability problems.
• Work with Maintenance and Technical Support to respond appropriately to potential utility supply upsets or equipment failure.
• Contact the appropriate help if there is a problem or an event (spill/deviation/incident) during processing.
• Communicate to other shifts regarding the status of the area operations and details of any issues/problems that have occurred at handover.
• Actively participate in assigned building & area operations such as safety audits, procedure co-ordination, 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, plant dress code, hygiene standards, and housekeeping requirements unique to the work area and job classification.

• Required: High School Diploma or equivalent
• Required: Legally authorized to be employed in the United States; no sponsorship expected for employment visa status
• Required: Completion of Post Offer Exam or Work Simulation if applicable
• Required: Ability to effectively communicate (electronic, written and verbal)
• Required: Basic computer skills (desktop software)
• Required: Minimum 3 years previous experience in operations

• Previous experience in facility/area start-up environments
• Previous experience in a pharmaceutical manufacturing operation with PSM-regulated/hazardous chemicals
• Ability to assume leadership and prioritize daily priorities without direct supervision
• Solid understanding of FDA guidelines and cGMP requirements
• Strong organizational skills and ability to handle and prioritize multiple requests
• Knowledge of lean manufacturing principles
• Flexibility – ability to troubleshoot and triage challenges
• Ability to understand technical nomenclature and language as well as work with mathematical formulas
• Manual material handling as appropriate
• Bend, reach, stretch, climb ladders, and work in tight spaces
• Stand for long periods

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