Downstream Processing Supervisor

Downstream Processing Supervisor

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.

Pay and Benefits

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)

Workplace Type

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

Application Deadline

This position is anticipated to close on Sep 5, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.