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Job Title: Downstream Processing SupervisorJob Description

The supervisor is accountable for the success and oversight of downstream manufacturing processes. This includes conducting a variety of functions related to Downstream Biopharmaceutical Manufacturing such as large-scale chromatography, viral inactivation, viral filtration, ultrafiltration, and diafiltration, as well as aseptic filling of bulk drug substances.

Responsibilities

+ Execute manufacturing batch records, work instructions, and SOPs with minimal instruction, focusing on proactive ‘right the first time’ executions.

+ Assist with batch record reconciliation.

+ Maintain suite, supplies, equipment, logbooks, and data in accordance with site SOPs and policies.

+ Document all activities to meet cGMP requirements, including daily record reviews and database management.

+ Forecast and resolve supply and raw material deficiencies, and identify and resolve scheduling conflicts.

+ Identify deviations, assist in investigations/root cause analysis, and provide input on major/critical deviations.

+ Represent the manufacturing team at tier meetings.

+ Practice and promote safe work habits and adhere 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 manage documents 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 members 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 ways to improve performance.

+ Complete production plans 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 serve as a Subject Matter Expert on various techniques.

Essential Skills

+ 5-9 years of experience working in cGMP manufacturing with a high school diploma.

+ 2+ years of experience in a pharmaceutical manufacturing setting producing large-scale pharmaceuticals in a lead or supervisory role.

+ Knowledge of cGMP practices.

+ Strong math skills.

+ Experience with cleanroom and aseptic techniques.

+ Proficiency in MS Office.

+ Critical thinking and problem-solving capabilities.

+ Detail-oriented.

+ Results-driven.

Additional Skills & Qualifications

+ High school diploma or GED required; Bachelor's degree preferred.

+ Experience in a cGMP environment preferred.

+ Knowledge of aseptic techniques or chemical concepts preferred.

Work Environment

The work environment includes cleanroom/aseptic suites where you must be willing to gown up. The position requires working night shifts from 6:15 PM to 6:45 AM on a rotating 12-hour shift schedule, working 7 days out of a 2-week period. You must be willing to wear a full gowning suit, including a bodysuit, gloves, hair and beard nets, face covers, and safety glasses. The use of makeup, jewelry, nail polish, cologne/perfume, and scented lotions or hair care products is prohibited. You should be able to meet cleanroom gowning requirements, 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 May 12, 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.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.