Downstream Processing Supervisor Position Available In St. Louis, Missouri

Job Title:

Downstream Processing Supervisor Job Description The Downstream Processing Supervisor is accountable for overseeing the success of downstream manufacturing processes in the biopharmaceutical sector. This role involves executing a variety of functions including large-scale chromatography, viral inactivation, filtration techniques, and aseptic filling of bulk drug substances. The supervisor will focus on proactive ‘right the first time’ executions and is responsible for the reconciliation of batch records. Responsibilities Execute manufacturing batch records, work instructions, and SOPs with minimal instruction. Assist with batch record reconciliation and maintain all department functions such as suite, supplies, equipment, logbooks, and data in accordance with site SOPs and policies. Document all activities to meet cGMP requirements and conduct daily record reviews. Forecast and resolve supply and raw material deficiencies and identify scheduling conflicts with a one-week outlook. Identify deviations, assist in investigations/root cause analysis, and provide input on major/critical deviations. Represent the manufacturing team at tier meetings and practice safe work habits adhering to safety procedures. Utilize manufacturing process knowledge and investigational skills to resolve manufacturing issues and drive continuous improvement. Provide feedback on document revisions and manage batch production records and manufacturing procedures. Maintain a safe and clean work environment by educating and directing personnel to ensure compliance with policies and procedures. Coordinate training with the team either in class or on the floor as needed. Build cross-functional relationships and enhance relationships with team members. Provide frequent feedback and coaching to others on improving performance. Complete production plans by scheduling and assigning personnel, prioritizing tasks, supervising progress, revising schedules, and reporting results. Lead shift exchanges and daily huddles for the team as required, acting as a liaison with other groups within the manufacturing organization. Essential Skills Prior supervisory experience or experience managing direct reports, including HR processes, independent decision-making, and performance management. Large-scale pharmaceutical manufacturing experience. Bachelor’s degree in STEM with 2+ years in a supervisor role within pharmaceuticals, or 5 years total in manufacturing. Additional Skills & Qualifications 5-9 years of experience in lead biopharmaceutical or pharma operating positions with a HS Diploma. Experience in cGMP environment preferred. Knowledge of cGMP practices. Strong math skills, aseptic techniques, and chemical concepts preferred. Critical thinking and problem-solving capabilities. Detail-oriented and results-driven. Efficient in MS Office. Work Environment The role is based in cleanroom/aseptic suites, requiring full gowning attire including bodysuit, gloves, hair and beard nets, face covers, and safety glasses. The night shift operates from 6:15pm to 6:45am on a rotating 12-hour shift schedule. Employees work 7 days out of a 2-week period following a 223 schedule. Candidates must be able to lift a minimum of 25 lbs independently and stand for 80% of the shift.