Downstream Processing Supervisor *43-48/HR

About the role

The Downstream Processing Supervisor is accountable for the oversight and success of downstream manufacturing processes within biopharmaceutical manufacturing. This role involves conducting various functions such as large-scale chromatography, viral inactivation, viral filtration, ultrafiltration, diafiltration, and aseptic filling of bulk drug substances.

Responsibilities

• Execute manufacturing batch records, work instructions, and SOPs with minimal guidance, focusing on proactive, right-first-time execution.
• Assist with batch record reconciliation and complete all departmental functions, including maintaining suites, supplies, equipment, logbooks, and data in line with site SOPs and policies.
• Document all activities to meet cGMP requirements, including daily record review, task completion, and database management.
• Forecast and resolve supply and raw material deficiencies, and identify and resolve scheduling conflicts with a one-week outlook.
• Identify deviations, assist in investigations and root cause analysis, and provide input on major or 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.
• Provide feedback on document revisions and 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 members, 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 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 a liaison with other groups within the manufacturing organization, and serve as a subject matter expert on various techniques.

Qualifications

• Experience in a supervisory role with responsibility for managing direct reports, including handling HR processes, independent decision-making, and performance management.
• Large-scale pharmaceutical manufacturing experience, with a preference for a BS degree in STEM and 2+ years in a supervisory role within pharmaceuticals or 5 years total in manufacturing.
• Proficiency in cleanroom operations, aseptic techniques, and cGMP practices.
• Strong critical thinking and problem-solving capabilities, detail-oriented, and results-driven.
• Efficient in MS Office applications.
• 5-9 years of relevant work experience based on education, with a preference for experience in the pharmaceutical industry.
• Experience in cGMP environments and strong math skills related to aseptic techniques and chemical concepts.
• Open to candidates with a high school diploma or GED and relevant experience in lead biopharmaceutical or pharmaceutical operating positions.

Work Environment

• Clean room/aseptic suite environment requiring willingness to gown up, including a full gowning suit with bodysuit, gloves, hair and beard nets, face covers, and safety glasses.
• Prohibited items include makeup, jewelry, nail polish, cologne/perfume, and scented lotions or hair care products.
• Day shifts from 6 am to 4:30 pm with 10-hour shifts.
• Must be able to lift at least 25 lbs independently and stand for 80% of the shift.

Pay

• $43.00 - $48.00/hr.

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)