Upstream Manufacturing Associate III Sun-Wed, Shift

Manufacturing Associate III

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, specializing in 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.

Key Experience for Manufacturing Associate, Upstream

• Experienced in GMP upstream manufacturing; especially with Suspension and adherent cell cultures, T-Flasks, roller bottles, bioreactors (rocker bioreactors 20/50L through 500L Single use bioreactors), and aseptic operations in BSC for the production of Mabs
• Specific equipment/systems that we are using include, Cytiva SUB's, XDUO buffer SUM's 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. Could 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. Perform 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.
• 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.

Qualifications

• With high school diploma:
  Normally requires 3-6 years of related experience required or an Associate's Degree in Life Sciences/Engineering field. Biotech Certificate preferred
• With Bachelor's degree:
  Normally requires 1-4 years of related experience
• Demonstrated knowledge of CGMP manufacturing.
• Knowledge of laboratory and pharmaceutical production equipment.
• 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…