With high school diploma: Normally requires 6+ years of related experience required or an associate degree in Life Sciences/Engineering field. Biotech Certificate preferred
With Bachelor's degree: Normally requires 3+ 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 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, weekend, holiday work and overtime at times, as dictated by the 365-day per year production schedule
Ability to work in a clean room environment and comply with hygiene standards and use of special garments. Additionally, personal protective equipment must be worn due to safety requirements
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
Benefits
Health insuranceVision insurance
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 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.
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 as well as 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
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.) and 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
Provide knowledge in areas of training process improvements
Such additional responsibilities as the Company may also assign
Rentschler · Milford, MA