What are the responsibilities and job description for the Process Manager, Upstream Process Development position at Rentschler Biopharma SE?
locations
Milford, MA, United States
time type
Vollzeit
posted on
Heute ausgeschrieben
job requisition id
JR2091
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!
Duties and Responsibilities
-
Develop clinical and commercial processes for Upstream unit operations including harvest
- Design and evaluate experiments to develop, optimize, characterize, or scale-up/ scale down processes
- Employ QbD principles when using univariate and multivariate studies in preparation for PPQ campaigns
- Align and harmonize methods and approaches with international colleagues
- Lead, train, and mentor junior lab staff
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Identify and evaluate new and existing technologies for more efficient processing, improved control, and increased process knowledge
- Contribute to process science ways-of-working and infrastructure improvements
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Transfer programs to manufacturing.
- Provide process descriptions and gap analysis
- Collaborate with MSAT on change controls
- Support Manufacturing and MSAT as the process Subject Matter Expert
- Support Manufacturing and Quality with deviation closures and appropriate CAPAs
-
Interface with clients.
- Analyze, prepare, and formally present data
- Collaborate on client approved documents
- Provide technical consulting as a Subject Matter Expert
-
Author documents
- Experimental protocols, technical reports, risk assessments, gap assessments, SOPs, facility fit assessments
- Process Subject Matter Expert review on batch records
- CMC dossier sections for IND/ IMPD and BLA/ MMA
Qualifications
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Years of experience and education (one of the following):
- A university degree and 10 years of related experience
- A Master’s degree and 7 years
- A PhD and 5 years of experience
- Expertise in bioreactor operation, scale-up/ scale-down principles, the use of statistical tools for data analysis and DoE, CMC dossier sections relating to process definitions, and working effectively with other departments
- The candidate must demonstrate critical thinking, be self-motivated, accountable, inquisitive, and have excellent organization and communication skills, and demonstrates the ability to work both independently and as a member of local and global teams
- Excellent customer service skills and ability to meet client project deadlines
- Flexibility of hours to support process development or MFG floor activities over weekends and holidays. Weekend and holiday hours are compensated per company policies
- Flexibility to switch between projects
- Advanced ability with Microsoft Office (Word, Excel, and PowerPoint)
Preferred Qualifications
- AMBR and single-use vessels
- Clarification (Harvest) unit operations and principles
- Process Qualification/ Process Validation (PPQ)
- QbD principles
- Continued Process verification (CPV)
- Regulatory requirements
- Experience with audits
Working Conditions
-
Laboratory and manufacturing clean-room environments working with chemical reagents and processing equipment
- Compliance with Personal Protective Equipment, clean room gowning, and EH&S requirements
- Normal office working conditions: computer, phone, files, printer, etc
- Interaction with people in the lab, other departments, and clients
- Fast-pace environment with job completion deadlines
Physical Requirements
- Lifting up to 25 lbs
- Standing/walking in lab environment for extended periods
- Sitting in office environment for extended periods for computer-based work
Brauchen Sie Hilfe?
Wenn Sie Unterstützung beim Hochladen Ihrer Bewerbung brauchen, wenden Sie sich bitte an unser Recruiting-Team:
welcome@rentschler-biopharma.com
