Process manager process development

locations

Milford, MA, United States

time type

Vollzeit

posted on

Heute ausgeschrieben

job requisition id

JR2381

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 SE ist ein führendes Auftragsentwicklungs- und Produktionsunternehmen (CDMO) und ausschließlich auf Kundenprojekte fokussiert. Wir bieten maßgeschneiderte Full-Service-Lösungen für die Bioprozessentwicklung und die Herstellung komplexer Biopharmazeutika. Als deutsches Familienunternehmen mit internationalem Footprint und globaler Reichweite verbinden wir Experten, Expertise und langjährige Erfahrung, um zusammen mit unseren Kunden beste Lösungen zu entwickeln.

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.

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
• 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
• 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

• 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
• CHO antibody production as well as fed-batch cell culture process experience preferred
• 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

• Late-stage development and process characterization
• 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:

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