Manufacturing Lead Upstream - Nights

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 back-up for the supervisor/manager, as needed
• Trains and mentors junior associates to enhance team capabilities
• Serves as the functional lead for manufacturing execution responsibilities
• Contributes to manufacturing continuous improvement efforts
• Serves as the subject matter expert (SME) in at least two core responsibilities for manufacturing assigned area
• Maintains training to perform all required activities
• Performs other duties, assigned

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 operation (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 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

Environmental Conditions

• Will work in warm/cold environments (0-100F)