Production Lead

The Production Lead is responsible for operating production equipment, completing associated documentation, and directing production technicians on shift on the same duties. The production lead is also responsible for ensuring that the shift meets all safety, compliance, and performance goals while meeting production schedules. The position will coordinate with other departments such as QA, QC, Purchasing, Maintenance, and Material Control to ensure all support activities are completed in a manner that all performance goals and production schedules are met. The Production Lead will serve as the acting Production Supervisor in the absence of the Production Supervisor.

Core Responsibilities:

• Promote a positive, professional, and safe work environment by demonstrating integrity and a strong work ethic; ensure team members understand performance expectations and have the knowledge, skills, and tools needed to perform their duties.
• Provide timely positive and constructive feedback; train staff on production activities, organize daily work to accommodate training, assist the Production Supervisor with tracking completion, and communicate employee relations and performance management matters.
• Effectively utilize staff, materials, and equipment to safely produce quality products at optimal productivity; maintain appropriate supply inventory and identify and communicate opportunities to improve efficiency, increase productivity, and reduce costs.
• Ensure work, facility and pharmaceutical systems documentation, controlled substances, and waste-handling activities comply with Company SOPs, FDA cGMPs, DEA requirements, and applicable safety, health, environmental, state, and federal regulations.
• Maintain accurate operational documentation and reports, including shift handover reports, material usage reports, deviations, and safety investigations; promptly report incidents, complete investigations as necessary, and escalate issues regarding goals versus results.
• Facilitate problem resolution through strong working relationships with Analytical/QC, Quality Assurance, Maintenance, and Material Control; coordinate with QC Testing regarding the timing and prioritization of in-process sample requirements.
• Ensure production and support equipment is in proper operating condition and appropriately labeled with current status tags; collaborate with Maintenance and maintain housekeeping and 5S standards appropriate for a pharmaceutical manufacturing environment.
• Participate as an active member of the Emergency Response Team and complete required training and related activities; perform Production Technician duties as needed to support production schedules.

Qualifications: 

• AA/BA or equivalent with a minimum of 3–5 years of experience in a STEM field; or a high school diploma and/or Pharmaceutical Certification or equivalent with 7–10 years of experience.
• Experience working in a production Kilo-Lab and/or Plant; prior basic production laboratory skills are desirable.
• Good mechanical aptitude and the ability to provide technical guidance, including demonstrated leadership skills to direct a work group.
• Demonstrated attention to detail, problem-solving and multitasking skills, good judgment, and the ability to make decisions with guidance from senior team members or a supervisor.
• Good written and verbal communication skills, including the ability to read, analyze, and interpret English-language materials; write clearly and neatly; and communicate effectively with peers and managers.
• Ability to work independently and in a team environment, with a good understanding of Microsoft Office; a solid understanding of GMP and FDA regulations is desirable.
• Must be able to work rotating shifts. While performing the duties of this job, it is required to stand, walk, and use hands to operate objects, tools, or controls; reach with hands or arms; climb, balance, stoop, kneel, or crouch when necessary for job activity.
• Able to lift 50 lbs. and occasionally lift and/or move more than 100 pounds using available material-handling equipment.

Salary Range:

The salary range for this role is $90,000–$100,000 annually. This range represents a good‑faith estimate of the compensation we expect to offer for this position at the time of posting. Actual compensation will be based on factors such as relevant experience, skills, qualifications, and internal equity. In exceptional cases, compensation may exceed the stated range.

All full-time employees are eligible to participate in our annual incentive bonus program. Bonus targets vary by career level and are based on individual and company performance.