Rentschler Biopharma Inc.
Sr Engineer, Downstream MSAT page is loaded## Sr Engineer, Downstream MSATlocations:
Milford, MA, United Statestime type:
Vollzeitposted on:
Gestern ausgeschriebenjob requisition id:
JR2383**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.
RentschlerBiopharmaSE 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*** Lead Technology transfer of client products working closely in collaboration with process development, Manufacturing, Engineering and Quality* Partner with Process Science to ensure the design and scale up of processes, instruments, and equipment from the laboratory through pilot scale are executable by manufacturing operations when moving into full scale manufacturing* Partner with manufacturing to ensure that manufacturing operations are designed for success ensuring high quality batch records, robust processes, and new technology* Anticipate, respond to, and resolve issues that arise on the floor in production through use of master data, process, and product monitoring* Utilize MSAT team’s technical skills and process knowledge to participate and/or lead process investigations through to root cause determination. Collaborate within the organization to develop and execute effective CAPA* Proactively drive Process Performance Qualification together with MSAT USP, Process Science, Regulatory, Manufacturing, Validation and Quality* Leads process monitoring and control of manufacturing processes and continuous improvement programs* Provide troubleshooting, technical support and training on the shop floor* Regularly interact with Rentschler senior management and clients; interactions involve use of influencing, conflict resolution and balancing the interests of the clients with those of Rentschler* Work closely with clients to ensure that their projects are executed successfully through the transfer, implementation, validation, filing and licensing of their products* Partner with MSAT network teams and peers to share and adopt best practices and drive continuous improvement in all technical aspects of production* Support the business development function by providing technical expertise for Process facility fit evaluations and responses for RFPs* Responsible for authoring technical reports, manufacturing instructions, process validation documents and portions of regulatory submissions to support licensing client products and process changes* Support regulatory filings and responses to health authority questions. Author and review CMC sections for IND and BLA submissions**Qualifications*** Bachelor’s degree in STEM* 5+ years of related experience* The candidate should be self-motivated, accountable, inquisitive, and have excellent organization and communication skills* Experience with biologics drug substance process development and/or manufacturing operations* Experience in process transfer in and manufacturing technical operations* Experience leading process technology transfers for clinical or commercial biologic(s)* Experience with Quality systems such as Deviation, CAPA, Change Control systems* Escalate and resolve project issues/ roadblocks as appropriate* Ability to identify and resolve complex technical issues including quality investigations* Advanced proficiency with Microsoft Office**Preferred Qualifications*** Previous experience in a Contract Development Manufacturing Organization (CDMO) environment* Experience in process qualification/validation (PPQ) and/or continued process verification (CPV)* Unicorn, JMP, and MODDE**Working Conditions*** Normal office working conditions: computer, phone, files, fax, copier* Personal Protective Equipment must be worn as required #J-18808-Ljbffr
Milford, MA, United Statestime type:
Vollzeitposted on:
Gestern ausgeschriebenjob requisition id:
JR2383**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.
RentschlerBiopharmaSE 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*** Lead Technology transfer of client products working closely in collaboration with process development, Manufacturing, Engineering and Quality* Partner with Process Science to ensure the design and scale up of processes, instruments, and equipment from the laboratory through pilot scale are executable by manufacturing operations when moving into full scale manufacturing* Partner with manufacturing to ensure that manufacturing operations are designed for success ensuring high quality batch records, robust processes, and new technology* Anticipate, respond to, and resolve issues that arise on the floor in production through use of master data, process, and product monitoring* Utilize MSAT team’s technical skills and process knowledge to participate and/or lead process investigations through to root cause determination. Collaborate within the organization to develop and execute effective CAPA* Proactively drive Process Performance Qualification together with MSAT USP, Process Science, Regulatory, Manufacturing, Validation and Quality* Leads process monitoring and control of manufacturing processes and continuous improvement programs* Provide troubleshooting, technical support and training on the shop floor* Regularly interact with Rentschler senior management and clients; interactions involve use of influencing, conflict resolution and balancing the interests of the clients with those of Rentschler* Work closely with clients to ensure that their projects are executed successfully through the transfer, implementation, validation, filing and licensing of their products* Partner with MSAT network teams and peers to share and adopt best practices and drive continuous improvement in all technical aspects of production* Support the business development function by providing technical expertise for Process facility fit evaluations and responses for RFPs* Responsible for authoring technical reports, manufacturing instructions, process validation documents and portions of regulatory submissions to support licensing client products and process changes* Support regulatory filings and responses to health authority questions. Author and review CMC sections for IND and BLA submissions**Qualifications*** Bachelor’s degree in STEM* 5+ years of related experience* The candidate should be self-motivated, accountable, inquisitive, and have excellent organization and communication skills* Experience with biologics drug substance process development and/or manufacturing operations* Experience in process transfer in and manufacturing technical operations* Experience leading process technology transfers for clinical or commercial biologic(s)* Experience with Quality systems such as Deviation, CAPA, Change Control systems* Escalate and resolve project issues/ roadblocks as appropriate* Ability to identify and resolve complex technical issues including quality investigations* Advanced proficiency with Microsoft Office**Preferred Qualifications*** Previous experience in a Contract Development Manufacturing Organization (CDMO) environment* Experience in process qualification/validation (PPQ) and/or continued process verification (CPV)* Unicorn, JMP, and MODDE**Working Conditions*** Normal office working conditions: computer, phone, files, fax, copier* Personal Protective Equipment must be worn as required #J-18808-Ljbffr