Lead Upstream Manufacturing Associate

** Medizin vorantreiben, um Leben zu schützen. Gemeinsam.
** Dank vieler Jahrzehnte Erfahrung und unserer Leidenschaft für das, was wir tun, leisten wir einen essenziellen Beitrag zur weltweiten Verfügbarkeit von Biopharmazeutika, auch und gerade für Patienten mit seltenen und schweren Erkrankungen.
Rentschler Biopharma beschäftigt rund 1.400 Mitarbeiter und hat den Hauptsitz in Laupheim, Deutschland, sowie einen Standort in Milford, MA, USA. Im Jahr 2024 haben wir uns dem Global Compact der Vereinten Nationen angeschlossen und unterstreichen damit unser Engagement für Nachhaltigkeit.
Als unabhängiges Familienunternehmen leben wir nach dem Motto:
Many hands, many minds – ONE TEAM! Ein offenes, respektvolles Miteinander prägt unsere Arbeitswelt, in der Qualitätsbewusstsein, Sorgfalt und Verantwortung an erster Stelle stehen. Denn bei aller Vielfalt unserer Talente im Rentschler Team verfolgen wir gemeinsam einen Zweck:
Medizin voranzutreiben, um Leben zu schützen.
** 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…