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.
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 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) Manufacturing operations tasks requires operator to regularly remain on feet for shift
Pushing buffer containers ranging from 50L to 200L
Sitting 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, 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
Such additional responsibilities as the Company may also assign
Rentschler · Milford, MA