Downstream Processing Manager

Job Title Downstream Processing Manager Job Description The Downstream Processing Manager oversees and leads downstream biopharmaceutical manufacturing operations, ensuring safe, compliant, and efficient execution of large-scale processes. This role manages a team in a cleanroom environment and is accountable for chromatography, viral inactivation and filtration, ultrafiltration and diafiltration, and aseptic filling of bulk drug substance. The manager drives right-first-time execution, maintains cGMP compliance, and supports continuous improvement while coordinating resources, schedules, and training for a night-shift manufacturing team. Responsibilities Oversee and execute downstream manufacturing batch records, work instructions, and SOPs with minimal supervision, emphasizing proactive right-first-time performance. Assist with batch record reconciliation to ensure complete and accurate documentation of all production activities. Perform and supervise large-scale downstream unit operations, including chromatography, viral inactivation, viral filtration, ultrafiltration, diafiltration, and aseptic filling of bulk drug substance. Ensure all department functions are completed, including maintaining production suites, supplies, equipment, logbooks, and data in accordance with site SOPs and policies. Document all activities to meet cGMP requirements, including daily record review, completion of assigned tasks, and accurate data entry into relevant databases. Forecast and resolve supply and raw material deficiencies to prevent production delays. Identify and resolve scheduling conflicts with at least a one-week outlook, ensuring adequate staffing and resource allocation. Identify deviations, support investigations and root cause analyses, and provide input on major and critical deviations. Represent the manufacturing team at tier meetings and communicate operational status, issues, and improvement opportunities. Promote and practice safe work habits and strictly adhere to all safety procedures and guidelines. Apply manufacturing process knowledge and investigational skills to identify and resolve manufacturing issues and drive continuous improvement in process operations. Review and provide feedback on document revisions and document management activities, including batch production records and manufacturing procedures. Maintain a safe and clean work environment by educating and directing personnel to follow established policies, procedures, and housekeeping standards. Coordinate training for team members in classroom and on-the-floor settings, ensuring competency in downstream operations and cGMP requirements. Build and strengthen cross-functional relationships and foster strong collaboration with team members and other departments. Provide frequent feedback and coaching to team members to improve performance, support development, and reinforce accountability. Complete production plans by scheduling and assigning personnel, prioritizing tasks, supervising progress, revising schedules as needed, resolving operational problems, and reporting results. Lead shift exchanges and daily huddles, ensuring clear communication of priorities, issues, and expectations for the team. Act as a liaison with other groups within the manufacturing organization and serve as a subject matter expert on downstream techniques and processes. Ensure compliance with cleanroom and aseptic techniques, including proper gowning and adherence to contamination control practices. Support and uphold lean manufacturing principles to improve efficiency, reduce waste, and enhance process reliability. Essential Skills Prior supervisory experience managing direct reports, including handling HR processes, independent decision-making, and performance management. Large-scale pharmaceutical or biopharmaceutical manufacturing experience in downstream operations. Experience working in a cGMP manufacturing environment, with practical knowledge of cGMP practices. Proficiency with downstream unit operations such as chromatography, viral inactivation, viral filtration, ultrafiltration, and diafiltration. Demonstrated experience with aseptic techniques and cleanroom operations. Strong understanding of pharmaceutical production processes, including purification and bioreactor-related operations. Critical thinking and problem-solving capabilities, particularly in a manufacturing or process environment. High attention to detail and strong documentation skills to support cGMP compliance. Results-driven mindset with the ability to meet production goals and timelines. Proficiency in Microsoft Office applications for documentation, reporting, and communication. Ability to lead teams on a rotating night-shift schedule and manage operations in a 12-hour shift environment. Ability to lift a minimum of 25 pounds independently and stand for approximately 80% of the shift. Ability and willingness to meet cleanroom gowning requirements, including wearing full-body suits, gloves, hair and beard nets, face covers, and safety glasses. Additional Skills & Qualifications High school diploma or GED required; a bachelor’s degree in a STEM field is preferred. 5 to 9 years of relevant manufacturing experience, with experience level requirements varying based on education. At least 2 years of supervisory or leadership experience in a pharmaceutical or biopharmaceutical environment preferred. Experience in downstream biopharmaceutical or pharmaceutical operations, including purification and chromatography-based processes. Experience in pharmaceutical production or pharmaceutical industry operations, including exposure to bioreactors and purification systems. Knowledge of chemistry concepts and strong math skills to support process calculations and data analysis. Familiarity with lean manufacturing principles and continuous improvement methodologies. Experience working in cleanroom or aseptic suites, including adherence to strict contamination control practices. Comfort working in highly regulated environments with detailed SOPs, batch records, and quality systems. Ability to coach, mentor, and develop team members, providing constructive feedback and fostering a high-performance culture. Strong communication skills to interact effectively with cross-functional teams and represent manufacturing in meetings. Interest in large-scale biological and chemistry operations that support the manufacture of biologics used in pharmaceutical products, such as antibodies for autoimmune disease therapies. Work Environment This role operates in cleanroom and aseptic manufacturing suites, supporting large-scale downstream biopharmaceutical production. The position is on the night shift, working from approximately 6:15 p.m. to 6:45 a.m. on a rotating 12‑hour schedule (2‑2‑3 pattern), typically working 7 days over a 2‑week period. The schedule includes alternating work and off days, such as working Monday–Tuesday, off Wednesday–Thursday, working Friday–Sunday one week, then off Monday–Tuesday and working Wednesday–Thursday the next week. Team members must be willing and able to wear full cleanroom gowning, including a bodysuit, gloves, hair and beard nets, face covers and safety glasses, and must comply with restrictions on items such as makeup, jewelry, nail polish, cologne or perfume, and scented lotions or hair care products. Personnel must meet cleanroom gowning requirements, including the use of Tyvek garments and nitrile and/or latex gloves. The work requires standing for up to 80% of the shift and lifting at least 25 pounds independently. The environment is highly regulated and process-driven, with a strong emphasis on safety, cGMP compliance, aseptic technique, and teamwork. Employees work with large-scale biological and chemistry‑based equipment to produce biologics that support pharmaceutical products for advanced therapies. Job Type & Location Contract to Hire position based out of Saint Louis, MO. Pay And Benefits Pay range: $43.00 – $48.00 per hour. 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) Workplace Type Fully onsite position in Saint Louis, MO. Application Deadline Position anticipated to close on Jun 18, 2026. 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. Equal opportunity and fair chance: For all positions located in the city and county of San Francisco, qualified applicants with arrest and conviction records will be considered for employment. Massachusetts law: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Artificial Intelligence: The hiring process may use Artificial Intelligence (AI) to support parts of the hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by the hiring team. By applying, the applicant acknowledges and agrees that the application may be reviewed using AI tools. #J-18808-Ljbffr Actalent