Additional Information
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 III is focused on biologics manufacturing, which includes processing 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.
This position will follow an Overnight 4/3 schedule, 6pm-6:30am, Wed-Sat (working every other Wednesday).
Key Experience for Manufacturing Associate, Downstream
Experienced in GMP downstream manufacturing; especially with TFF, Chromatography systems and purification of Mabs
Specific equipment/systems that we are using include, Akta ready, Akta Process, XDUos buffer systems and disposable technology systems
Must have experience with troubleshooting of the equipment and of process and excellence in clinical manufacturing
Characteristics: adaptable to changes, works well cross functionally and with key stakeholders; self-motivated, takes initiative and drives for solutions with the team; can lead in the absence of the manager; train newer operators once up to speed
Other possible responsibilities may include writing deviations/investigations and revising batch records if needed
Duties and Responsibilities
Perform operations of the following (may be applicable to commercial scale product, development studies, clinical scale or validation activities). Strong knowledge and understanding of manufacturing process and equipment to perform various production steps
Ability to train employees
Subject matter expert operating production equipment, as needed
Monitor and record batch parameters, including computer data entry; complete relevant paperwork following GDP/GMP guidelines; p erform mathematical calculations related to production processes
Initiate new documents for procedures; may make minor revisions to existing documents
Work with support team on all necessary event investigations and inventory system cycle counts and discrepancies
Troubleshoot process problems and respond to alarms. Provide information for unplanned events, including entering data into event management software
Oversee training of new employees, track training requirements for team members ensuring appropriate training is completed prior to process execution
Order, receive and distribute supplies into production area as needed
Pushing buffer containers ranging from 50L to 200L
Sitting for periods of 2 to 3 hours
Knowledge of laboratory and pharmaceutical production equipment including but not limited to: autoclaves, process tanks, chromatography skids and columns, analytical equipment
Convey information to external stake holders (auditors, global colleagues, etc.). Oversee support for groups that support manufacturing (such as external cleaners, etc.)
Lead Continuous Improvement Teams (such as 5S, Gemba, OMT, etc.)
Demonstrate procedures as a part of training sessions for other team members; may schedule department or process activities which could involve coworkers; lead team meetings and facilitate multidepartment discussions
Provide knowledge in areas of training process improvements
Such additional responsibilities as the Company may also assign
Rentschler · Milford, MA