Upstream Manufacturing Associate III; Sun-Wed 1st Shift Pitman

Position: Upstream Manufacturing Associate III (Sun-Wed 1st Shift Pitman) - 3-6 Month Contract
locations

Milford, MA, United Statestime type Vollzeitposted on Gestern ausgeschriebenjob requisition idJR
2670

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.

This position is focused on biologics manufacturing, which includes processing in upstream (cell culture). Operators are expected to perform these processes while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which apply.

This role will follow a 1st Shift 4/3 schedule, 6am-6:30pm, Sun-Wed (working every other Wednesday).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 scheduledepartment 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)
Manufacturing operations tasks requires operator to regularly remain on feet for shift

Pushing buffer containers ranging from 50L to 200LSitting for periods of 2 to 3 hours

Demonstrated knowledge of CGMP manufacturing

Knowledge of laboratory and pharmaceutical production equipment including but not limited to: autoclaves, process tanks, chromatography skids and columns, analytical equipment

Proficiency in a variety of mathematical disciplines and able to work with both the metric and USA standards of measurement, and military time

Able to read and follow detailed written instructions and have good verbal/written communication skills

Able to write legibly and grammatically correct entries on records. Must be able to author technical procedures and create forms

Familiar with standard troubleshooting approaches (problem statement, root cause analysis, corrections, etc.)Good computer skills, knowledge of Microsoft Word, Excel Good interpersonal skills and be able to work effectively and efficiently in a team environment

Ability to meet schedule required; this position may include shift,…