About This Role

Our factories run 24/7 operations. Our manufacturing teams work 12-hour shifts (either Days or Nights) on a 2-2-3 calendar rotation.

Shift Details:

• 12-hour shifts
• Nights: 6:00 PM – 6:00 AM
• Rotating 2-2-3 schedule

The Manufacturing Associate, Lead plays a critical hands-on leadership role within a cGMP manufacturing environment, performing and documenting daily manufacturing operations while ensuring compliance, quality, and efficiency. This role works closely with the Manufacturing Supervisor to coordinate shift activities, allocate resources, and support production, validation, and continuous improvement initiatives.

What You’ll Do

• Execute manufacturing processing steps and manufacturing support activities in accordance with batch records, SLRs, control systems, and standard operating procedures.
• Monitor and control processes, serving as a subject matter expert (SME) for assigned unit operations and process steps.
• Coordinate and, as required, lead process steps while ensuring adherence to cGMP requirements.
• Partner with the Supervisor to schedule daily shift activities, plan resource allocation, and support production, validation, and project-related work.
• Ensure effective shift handoffs through clear communication of issues, priorities, and status updates.
• Document, review, and ensure completeness of cGMP documentation including batch production records (BPRs), SLRs, deviations, and equipment logbooks, with real-time review for accuracy and compliance.
• Develop, revise, and maintain cGMP documents as needed.
• Actively participate in training activities, manage individual training plans, and provide hands-on training and knowledge sharing to other associates.
• Observe employee performance, provide timely coaching, and deliver feedback to the Supervisor during mid-year and end-of-year evaluations.
• Initiate and investigate deviations, support root cause analysis, and develop corrective and preventive actions (CAPAs) under Supervisor guidance.
• Lead or participate in troubleshooting efforts and serve as a potential SME during audits.
• Support equipment and facility maintenance activities to ensure operational readiness and compliance.

Who You Are

You are an agile, accountable self-starter who thrives in a dynamic manufacturing environment and values accurate, ethical data recordkeeping. You learn quickly, follow procedures diligently, and take ownership of your work and team outcomes. As a technical expert across multiple unit operations, you bring strong process and equipment knowledge paired with the ability to lead, schedule work, train others, and collaborate effectively. You excel in teamwork, communicate clearly, resolve conflicts constructively, and approach coaching with patience and teachability. You are motivated by continuous improvement, professional growth, and contributing to a high-performing Parenteral Filling team.

Required Skills

• The following combinations of education and direct experience will be considered:
  • Bachelor’s degree in Science, Technology, Engineering, or Mathematics (STEM) or a related field from an accredited college or university with a minimum of 4 years of direct experience
  • Associate’s degree in Science, Technology, Engineering, or Mathematics (STEM) or related field from an accredited institution with a minimum of 4.5 years of direct experience
  • High school diploma or equivalent with a minimum of 5 years of direct experience
• Demonstrated experience working in a cGMP manufacturing environment
• Strong documentation, compliance, and process execution skills
• Ability to lead tasks, support teams, and collaborate effectively across shifts

Preferred Skills

• Prior Parenteral Filling experience
• Experience with TrackWise, DeltaV, and LIMS systems

 

Job Level: Professional

Additional Information

The base compensation range for this role is: $33.17-$43.27