Address
SalaryRentschler 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!
Duties and Responsibilities
- Supervision of the QC Microbiology group (2nd and 3rd shift), including day to day activities, data review, laboratory investigations and troubleshooting
- Managing lab inventory and EM/Micro back up inventory as needed
- Performing Investigations/CAPAs, OOS/OOT, aberrant results associated with microbiological testing
- Lead continuous improvement practices (QLP, 5S, LEAN, etc.)
- Ensure department readiness for audits by both internal and external authorities
- Represent quality management for microbiology and interface with investigators during these inspections
- Ensure compliance with testing SOP’s and specifications
- Prepare, review and revise SOP’s and specifications in compliance with GDP
- Write memos, reports, protocols, and other appropriate documentation for proper functioning of the lab operation
- Creating performance goals and setting deadlines that match the company's plans
- Overseeing workflow to assist employees in knowing their job responsibilities and delegated duties
- Coaching employees by giving them constructive feedback to help perform tasks
- Gathering and submitting performance reports to the department manager
- Helping to train new employees while adhering to company policies
Qualifications
- BS in Microbiology, biological science, or related scientific discipline
- 5+ years of related experience a cGMP biologics environment or master’s degree and minimum 3 years of related experience
- 2+ years in a supervisory role(s) is preferred
- Understanding of GMP’s with expectations of a commercial GMP environment
- Must communicate effectively (verbal and written) with director and peers. Written, communicate skills require full competence in following detailed written instructions, creating/revising SOP’s, and reports
- Hands on skills and knowledge of quality lab operations including the operation and troubleshooting of lab equipment
- Strong understanding of regulatory requirements of the biopharmaceutical industry
- Advanced knowledge of basic chemical and biological safety procedures/precautions
- Proficient in Microsoft Office – Outlook, Word, Excel, PowerPoint
Working Conditions
- Laboratory environment working with chemical reagents and analytical equipment
- Entry into the utility’s rooms for sampling
- Personal Protective Equipment must be worn as required
- Clean Room gowning and scrubs
- Normal office working conditions: computer, phone, files, fax, copier
- Will interact with other people
- Pace may be fast and job completion demands may be high
Physical Requirements
- PPE as required
- Frequent lifting up to 10 lbs
- Frequent standing/walking to work in lab environment for extended periods
- Frequent sitting for extended periods to use computer
