Downstream Manufacturing Associate III; Conract - Wed-Sat Overnight Shift

About Rentschler Biopharma

Rentschler Biopharma SE is a leading contract development and manufacturing organization (CDMO) focused exclusively on client projects. We offer customized full‑service solutions for bioprocess development and the production of complex biopharmaceuticals. With an international footprint and a global reach, we combine decades of experience to develop best‑in‑class solutions for our clients.

The Manufacturing Associate III is focused on biologics manufacturing, specifically downstream (purification) processes. Operations are conducted under cGMP, environmental health and safety guidelines, and any other applicable regulations. This role follows an overnight 4/3 schedule (6pm–6:30am), Wednesday through Saturday, working every other Wednesday.

• GMP downstream manufacturing experience, especially with tangential flow filtration, chromatography systems and monoclonal antibody purification.
• Hands‑on experience with Akta Ready, Akta Process, XDS buffer systems and disposable technology systems.
• Strong troubleshooting skills for equipment and process issues, with an emphasis on clinical manufacturing excellence.
• Adaptable to change, works well cross‑functionally, self‑motivated, initiates solutions, and can lead in the absence of a manager.
• Ability to train newer operators once they are up to speed.

• Operate downstream manufacturing equipment across commercial, development, clinical, or validation activities.
• Maintain strong knowledge of manufacturing processes and equipment to perform production steps accurately.
• Train employees and act as a subject‑matter expert on production equipment.
• Record batch parameters and complete relevant paperwork in compliance with GDP/GMP guidelines, including computer data entry and mathematical calculations.
• Initiate new documents for procedures and make minor revisions to existing ones.
• Collaborate with support teams on event investigations, inventory cycle counts, and discrepancy resolution.
• Troubleshoot process problems and respond to alarms promptly.
• Provide information for unplanned events, entering data into event‑management software.
• Oversee training of new employees, track training requirements, and ensure appropriate training is completed before process execution.
• Order, receive, and distribute supplies into the production area as needed.
• Push buffer containers ranging from 50L to 200L; sit for periods of 2–3hours during this activity.
• Work with laboratory and pharmaceutical production equipment, including autoclaves, process tanks, chromatography skids and columns, and analytical equipment.
• Communicate with external stakeholders (auditors, global colleagues, etc.) to convey information.
• Support groups that assist manufacturing (such as external cleaners).
• Lead continuous‑improvement teams (5S, Gemba, OMT, etc.) and demonstrate procedures as part of training sessions.
• Participate in team meetings and facilitate multi‑department discussions to drive process improvements.

• High school diploma or associate degree in Life Sciences/Engineering with 6+ years of related experience, or bachelor’s degree with 4+ years of related experience.
• Demonstrated knowledge of cGMP manufacturing.
• Strong familiarity with laboratory and pharmaceutical production equipment.
• Ability to read and follow detailed written instructions and communicate verbally and in writing.
• Clean, legible, and grammatically correct record entries.
• Experience authoring technical procedures and creating forms.
• Familiarity with standard troubleshooting approaches (problem statement, root cause analysis, corrective actions).
• Proficient computer skills, including Microsoft Word and Excel.
• Good interpersonal skills and ability to work effectively in a team environment.
• Ability to meet the required schedule, including shift, weekend, holiday work, and overtime as directed by the 365‑day production schedule.
• Ability to work in a clean‑room environment, comply with hygiene standards and use of special garments; personal protective equipment (PPE) required.
• Physical capability to lift up to 25lb and remain on feet during manufacturing operations.

• Normal office conditions: computer, phone, files, fax, copier.
• Manufacturing operations: operator remains on feet for the shift and may lift up to 25lb.
• PPE as required for safety and hygiene compliance.

Base pay range: $36/hr – $46/hr rentschler Biopharma is committed to fair and equitable compensation practices. The base salary may be modified over time. Additional benefits include an annual discretionary bonus program, medical insurance, a 401(k) program, and a comprehensive benefits package aligned with employee wellness.