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Rentschler Biopharma Inc.
Downstream Manufacturing Associate II (Contract)
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Based on Massachusetts data
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What they do
A Production Worker performs a variety of duties in a factory. Operates machinery, manages distribution and provides quality control inspection.
$43,246 / year median in Massachusetts
+9% projected growth
Job Description
Advancing medicine to save lives. Together. Thanks to many decades of experience and our passion for what we do, we make an essential contribution to the global availability of biopharmaceuticals, especially for patients with rare and serious diseases. 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. As a German family-owned company with an international footprint and global reach, we combine experts, expertise and years of experience to develop best-in-class solutions - together with our clients. Rentschler Biopharma has approximately 1,400 employees and is headquartered in Laupheim, Germany, with a site in Milford, MA, USA. In 2024, we joined the United Nations Global Compact, underlining our commitment to sustainability. As an independent family-owned company, we live by the motto: Many hands, many minds - ONE TEAM! Open, respectful cooperation characterizes our working environment, where quality awareness, diligence and responsibility are our top priorities. With all the diversity of our talents in the Rentschler team, we pursue one vision together: advancing medicine to save lives. The Manufacturing Associate II, Downstream Purification is focused on biologics manufacturing, specializing in downstream (purification). Operators are expected to perform these processes while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which apply. Wed-Sat 4/3 Day Shift, 6a-6:30p Duties and Responsibilities Perform operations of the following (may be applicable to commercial scale product, development studies, clinical scale or validation activities). Operate manufacturing process equipment to perform various manufacturing production steps . Knowledge on initiating new revisions for procedures. Proficient operating inside of a BSC, sampling, and performing with aseptic techniques. Monitor and record batch parameters, including computer data entry. Complete relevant paperwork following GDP/GMP guidelines. Troubleshoot process problems and respond to alarms. Provide information for unplanned events, including entering data into event management software. Order, receive and distribute supplies into production area as needed. Demonstrate procedures as a part of training sessions for other team members; may schedule department or process activities which could involve coworkers. Participate in (and may lead, as requested) team meetings and facilitate multidepartment discussions. Convey information to external stake holders (auditors, global colleagues, etc.). Provide support for groups that support manufacturing . Participate on Continuous Improvement Teams . May perform other duties as assigned. (During Production Processing these activities may increase) Knowledge of laboratory and pharmaceutical production equipment including but not limited to autoclaves, process tanks, chromatography skids and columns, analytical equipment. Familiar with standard troubleshooting approaches (problem statement, root cause analysis, corrections, etc.) Such additional responsibilities as the Company may also assign.