Manufacturing Associate II, Buffer & Media Prep

Overview

Advancing medicine to save lives. Together. Rentschler Biopharma SE is a leading contract development and manufacturing organization (CDMO) focused on client projects, offering customized full-service solutions for bioprocess development and production of complex biopharmaceuticals. As a German family-owned company with an international footprint, we combine experts and experience to develop best-in-class solutions with our clients. We are headquartered in Laupheim, Germany, with a site in Milford, MA, USA.

In 2024, we joined the United Nations Global Compact, reaffirming our commitment to sustainability. Our motto is:
Many hands, many minds – ONE TEAM. Open, respectful cooperation characterizes our working environment where quality, diligence and responsibility are top priorities. The Manufacturing Associate II, Buffer Media Services focuses on biologics manufacturing, specializing in preparation of buffers and media to support cell culture and purification teams, and provides support to central services for glass washing, autoclave, and weigh & dispense operations.

Other duties may be assigned within manufacturing operations, including supporting upstream and downstream processes. Operators perform these processes in compliance with cGMP, environmental health and safety guidelines, and applicable regulations.

• Perform operations of buffers and media preparation, weigh-and-dispense activities, and support manufacturing teams as needed (applicable to commercial scale, development studies, clinical scale, or validation activities).
• Support monitoring and documentation of batch-related activities, including data entry in electronic systems, and complete required documentation in accordance with GDP and cGMP guidelines.
• Provide subject matter expert input during training sessions for other team members and communicate effectively with external stakeholders (e.g., auditors and global colleagues).
• Collaborate with cross-functional groups to support manufacturing operations and troubleshoot using standard approaches (problem statement, root cause analysis, corrections, etc.).
• Operate process equipment to support various production steps; monitor and record batch parameters and complete relevant documentation per GDP/GMP guidelines.
• Develop subject matter expertise on benchtop equipment and train newer or less experienced technicians on applicable processes and procedures.
• Create and revise controlled documents (SOPs, MPRs, and forms) within Master Control; lead other technicians when a Lead Operator or Supervisor is not available.
• Perform SAP transactions and use Master Control as needed; maintain training, including OJTs, RAs, RUs, Compliance Wire, and Workday assignments.
• Order, receive, and distribute supplies to production areas as needed; maintain good knowledge of cGMP and cleanroom behavior.

• With high school diploma: typically 2–4 years of related experience; an associate degree in Life Sciences/Engineering with 1–3 years of related experience;
  Biotech Certificate preferred.
• With bachelor’s degree: typically 1–2 years of related experience.
• Proficiency in mathematical disciplines and ability to work with metric and US units; ability to read and follow detailed written instructions and communicate effectively (verbal and written).
• Adequate documentation skills, legibility, and grammatical accuracy in records; ability to meet schedule requirements, including shift, weekend, holiday work, and overtime as production schedules demand.
• Good with Microsoft Office (Outlook, Word, Excel). Strong interpersonal skills and ability to work effectively in a team.
• Experience with cGMP and cleanroom environments; strong understanding of laboratory and pharmaceutical production equipment (e.g., process tanks, SUMs, pumps, Filter Integrity Testers, tube management, analytical equipment).
• Ability to perform required SAP transactions and adhere to training requirements; physical ability for lifting up to 40 lbs and working in a fast-paced production setting.

• Manufacturing operations may require standing for extended periods, lifting up to 40…