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/ Responsibilities:
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Hands-on supervision of manufacturing staff including hiring, coaching, training, goal setting, professional development, overall performance management and assessment
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Maintain personal training requirements and assure that each team member is adequately trained and documented for the execution of production SOP’s and MPR’s
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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, and equipment preparation
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A thorough understanding of cell culture key performance indicators, cell counts, seeding densities, confluence, and the science behind the upstream production of mAb’s
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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
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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
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Author, revise and approve SOP’s, batch records, deviations and other documentation as required to ensure compliance
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In depth familiarities 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 Cell Culture
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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
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Assures that SAP transactions for process orders are executed on time and works with supply chain to resolve any discrepancies
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Schedules daily activities for the shift, tracks completion of activities and reports on progress to Cell Culture manufacturing manager
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Ensure 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
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Leads or oversees new employees training (as executed on the floor) to understand what new employees are trained to perform and can document in batch record, prevents task execution before training is documented
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Warrant activities in the suite are conducted safely and in accordance with Safety procedures
Ways of Working – Leadership Capabilities
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The Manufacturing Supervisor is in the suite as a working manager of the team members on the shift that reports to them. The function of the job requires coordination of the team, responsibility for achieving team objectives, personnel training, capabilities and team morale. Additionally, this role is highly involved in communicating and coordinating with support organizations and leadership.
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Characteristics: adaptable to changes, works well on the floor alongside of manufacturing associates, cross functionally and with key stakeholders. Self-motivated, takes initiative and drives for solutions with the team.
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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
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This position responsible for assuring training of new employees and for developing new competencies in existing/ transferred personnel. This can be done personally or by scheduling of the site’s qualified trainers (QT). Must be experienced with training models and focused on building competencies and behaviors to elevate the performance of team members.
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Monitors team culture provides clarity to misinformation and legacy attitudes and behaviors
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Elevates issues early, presents issues with options for quick and compliant resolution
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Provides feedback and SME support for training department process improvements
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Provides feedback to employee’s performance on the shift
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Leads team meetings and may facilitate multi-department discussions
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Supports a positive work environment that promotes inclusion and diversity
Qualifications
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With high school diploma:
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Required 5+ years of related experience required or an associate degree in Life Sciences/Engineering field, Biotech Certificate preferred
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Also 2+ years’ experience as a Lead operator, supervisor or manager in Life Sciences
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With Bachelor’s degree: Required 2-6 years of related experience
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Demonstrated proficiency in leading a team for 1+ years.
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Able to read and follow detailed written instructions and have good verbal/written communication skills
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Must be able to author technical procedures and create forms.
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Familiar with standard troubleshooting approaches (problem statement, root cause analysis, corrections, etc.)
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Good computer skills, knowledge of Microsoft Word, Excel
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Good interpersonal skills and be able to work effectively and efficiently in a team environment
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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
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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
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Proficient in BSC operations and aseptic technique
Working Conditions
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Normal office working conditions: computer, phone, files, fax, copier
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Personal Protective Equipment must be worn as required
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May require lifting amounts of 25 lbs
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Manufacturing operations tasks requires operator to regularly remain on feet for shift
Physical Requirements
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PPE as required
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May require lifting amounts of 25 lbs
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Manufacturing operations tasks requires operator to regularly remain on feet for shift