Downstream Processing Supervisor

Actalent • Saint Louis, MO

74d • $43 - $48

About The Position

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.

Requirements

• 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.

Nice To Haves

• High school diploma or GED required; Bachelor's degree preferred.
• Experience in a cGMP environment preferred.
• Knowledge of aseptic techniques or chemical concepts preferred.

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.

Benefits

• 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)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Administrative and Support Services
• Education Level: High school or GED
• Number of Employees: 1,001-5,000 employees