Production Shift Lead – 1st Shift

PolyPeptide is seeking a Shift Lead to oversee day-to-day manufacturing operations and help ensure the safe, compliant, and efficient production of Active Pharmaceutical Ingredients, APIs, and peptide-based products.

This role is ideal for someone with pharmaceutical manufacturing experience who enjoys being hands-on, leading teams, solving technical challenges, and keeping production activities moving safely and effectively. As a Shift Lead, you will provide daily direction, technical training, and operational support to manufacturing personnel while helping ensure production schedules, documentation standards, and cGMP requirements are met.

Your work will directly support PolyPeptide’s commitment to operational excellence, quality, safety, and on-time delivery to our customers.

Manufacturing leadership is critical to ensuring our processes are executed safely, consistently, and in compliance with regulatory requirements. In this role, you will be a key point of contact on shift, helping guide production activities, troubleshoot equipment or process issues, support team development, and ensure a smooth handoff between shifts.

This is a strong opportunity for someone who wants to grow as a manufacturing leader while staying closely connected to the science, equipment, and processes used in API and peptide manufacturing.

• Monitor and reinforce adherence to cGMP, FDA, DEA, EHS, and internal SOP requirements

• Ensure all team members follow PPE requirements and safe work practices

• Identify and address unsafe conditions promptly

• Support a strong safety and quality culture across the shift

• Develop daily work plans and assign shift activities based on production priorities

• Ensure shift activities align with production schedules, quality expectations, and efficiency goals

• Provide hands-on leadership and guidance to manufacturing personnel

• Maintain a professional work environment and ensure appropriate coverage for breaks and meal periods

• Help keep the team aligned, focused, and accountable throughout the shift

• Train team members on equipment operation, SOPs, chemistry processes, and documentation standards

• Support training through MasterControl and other required systems

• Maintain training and certification records

• Mentor team members and support continuous skill development

• Help build team capability, consistency, and confidence in manufacturing operations

• Execute and support manufacturing processes, including synthesis, purification, filtration, lyophilization, in-process testing, and other API or peptide manufacturing stages

• Operate, troubleshoot, and support equipment such as reactors, Nutsche filters, prep and analytical HPLC/UPLC systems, lyophilizers, pumps, ovens, and material-handling equipment

• Support equipment readiness and identify potential issues before they impact production

• Coordinate with cross-functional teams to keep operations moving efficiently

• Ensure batch records, shift reports, logbooks, and production documents are accurate, complete, and compliant at the end of each shift

• Review documentation daily and address errors or gaps in a timely manner

• Act as a witness for critical operations when required

• Support quality investigations, deviations, CAPAs, and corrective action implementation

• Reinforce strong documentation practices across the team

• Lead shift huddles and communicate priorities, status updates, and process or equipment concerns

• Ensure clear and complete handoffs between shifts

• Escalate safety concerns, equipment failures, documentation issues, and schedule risks promptly

• Help maintain alignment between Manufacturing, Quality, Engineering, Maintenance, and other support teams

• Identify opportunities to improve safety, reduce waste, increase efficiency, and strengthen process consistency

• Support implementation of process improvements and corrective actions

• Use sound judgment and data-driven decision-making to resolve operational challenges

• Promote accountability, ownership, and continuous improvement within the team

• Bachelor’s degree in a science-related field

• Minimum of 3 years of experience in pharmaceutical manufacturing or another regulated manufacturing environment

• Peptide manufacturing experience preferred

• Hands-on experience with SPPS reactors, filtration equipment, HPLC/UPLC, prep HPLC, and lyophilizers

• Strong understanding of chemical processes, manufacturing stages, and in-process analytics

• Ability to troubleshoot equipment and process issues

• Knowledge of hazardous materials handling, waste flow, and solvent management

• Proficiency with Microsoft Office

• AX or SAP experience preferred

• Ability to operate forklifts, drum dollies, hoists, and other material-handling equipment

You are a hands-on leader who can balance safety, quality, compliance, and production priorities. You communicate clearly, stay organized under pressure, and know how to keep a team focused on the work that matters most.

You are comfortable working in a regulated environment where documentation, consistency, and attention to detail are essential. You also enjoy training others, solving problems, and supporting continuous improvement on the manufacturing floor.

• Safety mindset

• Accountability and ownership

• Process discipline

• Team leadership

• Technical troubleshooting

• Strong communication and collaboration

• Documentation accuracy

• Problem-solving and continuous improvement

• Ability to prioritize and make sound decisions in a fast-paced environment

This role is performed in a GMP manufacturing and laboratory environment with exposure to chemicals, equipment noise, and temperature-controlled areas.

Physical demands may include:

• Prolonged standing, walking, and hands-on equipment operation

• Lifting up to 25 pounds and occasionally over 50 pounds with assistance

• Climbing, kneeling, and working around moving mechanical equipment

• Use of tools, pumps, reactors, and laboratory instruments

• Use of required PPE and adherence to safety and gowning procedures

Salary: $34-$42 per hour

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.