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 role will follow an overnight Pitman schedule, 5pm-5am.
Key Experience/ Responsibilities for Lead Upstream Manufacturing Associate
- Subject Matter Expert in cGMP upstream manufacturing; especially with Mammalian Cell Culture, Roller Bottles, Rocker Bioreactors, Fed batch and Profusion Bioreactors, Cell Harvest Clarification, Viral Inactivation, Buffer and Media preparation
- A thorough understanding of cell culture key performance indicators, cell counts, seeding densities, confluence, and the science behind the upstream production of mAb’s
- Specific equipment/systems that we are using include Cellmate roller bottle robot, 20L/50L wave bioreactor, Cytiva 200L & 500L single use bioreactor, TCU’s, BSC’s, roller racks, incubators and disposable technology systems; must have a thorough understanding of the equipment and controls as this role will be the front-line troubleshooting and correction role for the shift
- Must have experience with initiating, developing and revising SOP’s and Batch records for upstream processes
- Thoroughly familiar with the identification of actions and results that are outside procedures and limits which require escalation through events and deviations; responsibilities include leading and completing investigations of root causes and formally documenting/writing deviations for such events in upstream
- Subject matter expert for materials and the ordering of materials in time to meet the schedule; participates in inventory cycle counts and resolution/ corrective actions for discrepancies
- Assures that SAP transactions for process orders are executed on time and works with supply chain to resolve any discrepancies
- Schedules daily activities for coworkers on shift, tracks completion of activities and reports on progress to manufacturing supervisor
- Assures that executed batch records are reviewed thoroughly and all entries are correct before turning over to QA for approval; works to resolve batch record entry issues before they are reviewed by QA
- Assures activities in the suite are conducted safely and in accordance with Safety procedures
Ways of Working – Leadership Capabilities
- Collaborates with and provides open, honest, technically accurate information to support teams (Eng, Fac, PS, QA, QC, SC) during scheduling meetings, event/deviation investigations and process/ equipment troubleshooting
- This position is the lead Qualified Trainer for new employees or for developing new competencies in existing/ transferred personnel; must be experienced with training models and focused on building competencies and behaviors to elevate the performance of team members
- Monitors team culture provides clarity to misinformation and legacy attitudes and behaviors
- Elevates issues early, presents issues with options for quick and compliant resolution
- Provides feedback and SME support for training department process improvements
- Provides feedback to supervisor/ manager on employees’ performance on the shift
- Leads some team meetings and may facilitate multi-department discussions
- Supports a positive work environment that promotes inclusion and diversity
Standard Manufacturing Duties and Responsibilities for Associates
- The Key Experience and Ways of working distinguish the Lead Upstream Manufacturing Associate from the Manufacturing Associate roles. However, the Lead Associate is on the floor, operating the equipment and completing batch records alongside the manufacturing associates. The following manufacturing responsibilities are also performed
- Perform operations of the following (may be applicable to commercial scale product, development studies, clinical scale or validation activities):
- Perform, Monitor, Review, and record batch parameters, including computer data entry; complete relevant paperwork following GDP/GMP guidelines; perform mathematical calculations related to production processes
- 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
- Lead Continuous Improvement Teams (such as 5S, Gemba, OMT, etc.)
- Such additional responsibilities as the Company may also assign
- Proficient in BSC operations and aseptic technique
Qualifications
- With high school diploma: Normally requires 8+ years of related experience required or an associate degree in Life Sciences/Engineering field. Biotech Certificate preferred
- With Bachelor’s degree: Normally requires 6+ years of related experience
- 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 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.
- Proficient in BSC operations and aseptic technique
Working Conditions
- Normal office working conditions: computer, phone, files, fax, copier
- Personal Protective Equipment must be worn as required
- May require lifting amounts of 25 lbs
- Manufacturing operations tasks requires operator to regularly remain on feet for shift
Physical Requirements
- PPE as required
- May require lifting amounts of 25 lbs
- Manufacturing operations tasks requires operator to regularly remain on feet for shift