Downstream Processing Supervisor

Job Title:

Downstream Processing Supervisor Job Description

The Downstream Processing Supervisor is accountable for the success and oversight of downstream manufacturing processes, with responsibilities that encompass large scale chromatography, viral inactivation, viral filtration, ultrafiltration, diafiltration, and aseptic filling of bulk drug substances.

• Execute manufacturing batch records, work instructions, and SOPs with a focus on 'right the first time' executions, and assist with batch record reconciliation.
• Complete all department functions such as maintaining suite, supplies, equipment, logbooks, and data in accordance with site SOPs and policies.
• Document all activities to meet cGMP requirements, including daily record review, tasks, and databases.
• Forecast and resolve supply and raw material deficiencies, and identify and resolve scheduling conflicts with a one-week outlook.
• Identify deviations, aid in investigations/root cause analysis, and provide input on major/critical deviations.
• Represent the manufacturing team at tier meetings and promote safe work habits by adhering to safety procedures and guidelines.
• Utilize manufacturing process knowledge and investigational skills to identify and resolve manufacturing issues, driving continuous improvement in process operations.
• Provide feedback on document revisions and/or management including batch production records and manufacturing procedures.
• Maintain a safe and clean work environment by educating and directing personnel to ensure compliance with established policies and procedures.
• Coordinate training with team either in class or on the floor, as needed, and help build cross-functional relationships.
• Provide frequent feedback and coaching to others to improve performance.
• Complete the production plan by scheduling and assigning personnel, prioritizing tasks, supervising progress, revising schedules, resolving problems, and reporting results.
• Lead shift exchanges and daily huddles for the team as required, act as liaison with other groups within the manufacturing organization, and be a Subject Matter Expert on various techniques.

• 5-9 years of experience working in cGMP manufacturing with a high school diploma or GED;
  Bachelor's degree preferred.
• 2+ years of supervisory and leadership experience in a pharmaceutical manufacturing setting.
• Experience in a cGMP environment and knowledge of cGMP practices.
• Strong math skills, aseptic techniques, and chemical concepts.
• Critical thinking and problem-solving capabilities.
• Detail-oriented and results-driven.
• Proficiency in MS Office.

• Experience with bioreactor, chromatography, purification, and Lean manufacturing.
• Familiarity with cleanroom and aseptic techniques.

The work environment includes cleanroom and aseptic suites where full gowning is required, including bodysuit, gloves, hair and beard nets, face covers, and safety glasses. The role involves night shifts from 6:15 pm to 6:45 am with rotating 12-hour shifts, working 7 days out of a 2-week period. The position requires the ability to lift a minimum of 25 lbs independently and the ability to stand for 80% of the shift.

This is a Contract to Hire position based out of Saint Louis, MO.

The pay range for this position is $43.00 - $48.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

This is a fully onsite position in Saint Louis,MO.

This position is anticipated to close on Feb 27, 2026.