Manufacturing Lead Upstream - Days

Responsibilities

• Adheres to strict safety protocols and contributes to building a culture of safety within the manufacturing environment.
• Leads, executes, and documents manufacturing processing steps or support activities, process monitoring and control within a functional area, ensuring compliance with standard operating procedures (SOPs) and Current Good Manufacturing Practice (CGMP) regulations.
• Oversees, leads, or performs in-process sampling and testing (e.g., pH, conductivity, visual inspection).
• Executes validation protocols according to CGMP SOPs and provides approval as a backup for the supervisor/manager, as needed.
• Trains and mentors junior associates to enhance team capabilities.
• Serves as a backup for the supervisor, supporting scheduling daily activities on the manufacturing floor.
• Leads troubleshooting for operational issues.
• Assists the supervisor with shift huddles, tier escalations, investigations, and continuous improvement projects.

Requirements

• High School Diploma/GED with 8+ years of experience in a CGMP manufacturing environment; or Associate’s degree in life science with 6+ years of experience in a CGMP manufacturing environment; or Bachelor’s degree in life science with 4+ years of experience in a CGMP environment; or Equivalent Military training or experience.
• Preferred Requirements: Experience with multiple unit operations (e.g., Chromatography, UFDF, etc.) and fully qualified in at least one functional area.

Physical Demands

• Ability to ascend or descend ladders, scaffolding, ramps, etc.
• Will work in an environment which may necessitate respiratory protection.
• Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.
• Ability to stand for prolonged periods of time up to 240 minutes.
• Ability to sit for prolonged periods of time up to 240 minutes.
• Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers.
• Ability to conduct work that includes moving objects up to 33 pounds.
• Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions.