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Upstream Manufacturing Associate Iii

4 months ago

Milford, United States Rentschler Biopharma SE Full time

Rentschler Biopharma ist ein führendes Auftragsentwicklungs
- und Produktionsunternehmen (CDMO) für Biopharmazeutika. Am Hauptsitz in Laupheim, Deutschland, sowie einem zweiten Standort in Milford, MA, USA, bieten wir Full-Service Lösungen für die Bioprozessentwicklung und die Herstellung hochwertiger Biopharmazeutika sowie damit verbundene Beratungsleistungen einschließlich Projektplanung und regulatorischer Unterstützung an. In Stevenage, UK, haben wir das auf Zell
- und Gentherapie spezialisierte Unternehmen Rentschler ATMP Ltd. gegründet.

Wir sind ein Familienunternehmen mit rund 1.400 Mitarbeiter/-innen aus 25 Nationen. Was uns bei Rentschler Biopharma vereint, ist die Leidenschaft für das, was wir tun. Wir versetzen unsere Partner in die Lage, Patienten mit schweren oder seltenen Erkrankungen zu helfen.

Mit unserer Hingabe und unserem Wissen wandeln wir medizinische Forschung in ausgezeichnete Biopharmazeutika um. So leisten wir einen entscheidenden Beitrag zur weltweiten Verfügbarkeit essenzieller Therapien. Um unser langfristiges und nachhaltiges Wachstum zu sichern, bauen wir unser Team weiter aus. Werden Sie Teil unseres einzigartigen Teams und gestalten Sie mit uns gemeinsam die Zukunft der Biopharma-Branche

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
- Other possible responsibilities may include writing deviations/investigations and revising batch records if needed

**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: 6+ years of related experience required or an Associate’s Degree in Life Sciences/Engineering field. Biotech Certificate preferred
- With Bachelor’s degree: 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 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

Working Conditions
- Normal office working conditions: computer, phone, files, fax, copier
- Personal Protective Equipment mu