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Scientific Fellow, Chemistry-9288140119
Description
Janssen Supply Chain, a member of Johnson & Johnson's family of companies, is recruiting for a Scientific Fellow, Chemistry, to be located in Raritan, NJ.
Janssen Supply Group, LLC is part of Janssen Supply Chain, a global organization responsible for supplying medicines to markets around the world. With Quality as their primary focus, this group strives to provides access and affordability through innovation and strong collaboration with their R&D and Commercial partners to deliver life changing solutions for patients in need.
The Scientific Fellow, Chemistry, Process Science and Applied Analytics (PSAA) will partner with PDMS Chem development to help develop the most efficient synthesis and process, balancing chemistry, engineering, modeling and predefined workstreams, to develop the best possible Gen 1 process, regardless of timeline, following DtV and DmF principles. This role will lead investigations into process performance issues, leveraging PDMS and GTS resources. Partner with PDMS and external vendors to deliver one single Gen2 process, when needed, incorporating all needed changes into one single process update. Be SPOC and manage the vendor relationship on the technical side. Mentor and guide GTS technical resources, including TLI’s, process owners, functional experts, PIP’s, etc, internal and external, on the best possible process solutions. Support other life cycle management, L&A and growing market teams with chemistry and process solutions. Mentor and manage the development of junior chemists in this function.
The Scientific Fellow will integrate chemistry and engineering and help deliver robustness, efficiency, low environmental impact and fuller mechanistic process understanding. Support PSAA efforts in PAT, modeling and process analytics. Represent JSC and GTS perspectives with CMC teams, NPL’s, Chemistry SAB’s, CMC council, etc. Influence more science and understanding based CTD’s.
Lead investigations into process performance issues, leveraging PDMS and GTS resources. Bring JSC priorities to these issues, securing and coordinating PDMS, AD PSAA and other GTS resources as needed, integrating the efforts for rapid resolution. Bring to bear external resources as needed. Develop external partners to enable rapid use. Support other life cycle management, L&A and growing market teams with chemistry and process solutions.
Partner with PDMS and external vendors to deliver one single Gen2 process, when needed, incorporating all needed changes into one single process update. Identify, develop and cultivate a set of preferred external development partners and establish the needed business framework for appropriate response and performance. Be SPOC and manage the vendor relationship on the technical side, directly leading the external resources, crafting the action plans and strategies, and creating the required regulatory documentation.
Mentor and guide GTS technical resources, including TLI’s, process owners, functional experts, PIP’s, etc, internal and external, on the best possible process solutions. Help internal and external plants adopt the S88, real time data mindset, through ESI, PIP’s, and stakeholder management. Mentor and manage the development of junior chemists in this function as assigned.
Qualifications
A minimum of a doctorate level degree (PhD, MD, PharmD, etc.) is required. A minimum of 9 years of related experience is required. Experience with chemical process route scouting, chemical process development, process science, process analytics, analytical science, scale-up and validation, tech transfer, external partner development and management, CTD generation, and GMP compliance is required. Exposure to Quality Assurance and Regulatory Compliance cGMP and EH&S is required. Project Management qualifications (FPX certification or equivalent) is desired. Operational Excellence experience in Lean, Process Excellence, and/or Design Excellence is desired. The ability to operate in a complex global matrix organization, i.e., multiple stakeholders, with limited guidance and supervision is required. The ability to design and lead technical teams in support of Root Cause Analysis on processing deviations and/or Supply Chain escalations and coordinate action planning and execution is preferred. The ability to independently develop and/or assess Business Cases, perform feasibility studies, develop action plans related to Processes Improvements, Costs and/or Quality improvements is preferred, and the ability to develop and access a network of Subject Matter Experts is preferred. Strong communication and leadership skills are highly preferred. This position will require up to 70% domestic and international travel.
Primary Location:North America-United States-New Jersey-Raritan
Organization: JANSSEN SUPPLY GROUP, LLC (6046)
Job Function: R&D Engineering (R&D)
Certain sites within the Johnson & Johnson family of companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Scientific Fellow, Chemistry-9288140119
Description
Janssen Supply Chain, a member of Johnson & Johnson's family of companies, is recruiting for a Scientific Fellow, Chemistry, to be located in Raritan, NJ.
Janssen Supply Group, LLC is part of Janssen Supply Chain, a global organization responsible for supplying medicines to markets around the world. With Quality as their primary focus, this group strives to provides access and affordability through innovation and strong collaboration with their R&D and Commercial partners to deliver life changing solutions for patients in need.
The Scientific Fellow, Chemistry, Process Science and Applied Analytics (PSAA) will partner with PDMS Chem development to help develop the most efficient synthesis and process, balancing chemistry, engineering, modeling and predefined workstreams, to develop the best possible Gen 1 process, regardless of timeline, following DtV and DmF principles. This role will lead investigations into process performance issues, leveraging PDMS and GTS resources. Partner with PDMS and external vendors to deliver one single Gen2 process, when needed, incorporating all needed changes into one single process update. Be SPOC and manage the vendor relationship on the technical side. Mentor and guide GTS technical resources, including TLI’s, process owners, functional experts, PIP’s, etc, internal and external, on the best possible process solutions. Support other life cycle management, L&A and growing market teams with chemistry and process solutions. Mentor and manage the development of junior chemists in this function.
The Scientific Fellow will integrate chemistry and engineering and help deliver robustness, efficiency, low environmental impact and fuller mechanistic process understanding. Support PSAA efforts in PAT, modeling and process analytics. Represent JSC and GTS perspectives with CMC teams, NPL’s, Chemistry SAB’s, CMC council, etc. Influence more science and understanding based CTD’s.
Lead investigations into process performance issues, leveraging PDMS and GTS resources. Bring JSC priorities to these issues, securing and coordinating PDMS, AD PSAA and other GTS resources as needed, integrating the efforts for rapid resolution. Bring to bear external resources as needed. Develop external partners to enable rapid use. Support other life cycle management, L&A and growing market teams with chemistry and process solutions.
Partner with PDMS and external vendors to deliver one single Gen2 process, when needed, incorporating all needed changes into one single process update. Identify, develop and cultivate a set of preferred external development partners and establish the needed business framework for appropriate response and performance. Be SPOC and manage the vendor relationship on the technical side, directly leading the external resources, crafting the action plans and strategies, and creating the required regulatory documentation.
Mentor and guide GTS technical resources, including TLI’s, process owners, functional experts, PIP’s, etc, internal and external, on the best possible process solutions. Help internal and external plants adopt the S88, real time data mindset, through ESI, PIP’s, and stakeholder management. Mentor and manage the development of junior chemists in this function as assigned.
Qualifications
A minimum of a doctorate level degree (PhD, MD, PharmD, etc.) is required. A minimum of 9 years of related experience is required. Experience with chemical process route scouting, chemical process development, process science, process analytics, analytical science, scale-up and validation, tech transfer, external partner development and management, CTD generation, and GMP compliance is required. Exposure to Quality Assurance and Regulatory Compliance cGMP and EH&S is required. Project Management qualifications (FPX certification or equivalent) is desired. Operational Excellence experience in Lean, Process Excellence, and/or Design Excellence is desired. The ability to operate in a complex global matrix organization, i.e., multiple stakeholders, with limited guidance and supervision is required. The ability to design and lead technical teams in support of Root Cause Analysis on processing deviations and/or Supply Chain escalations and coordinate action planning and execution is preferred. The ability to independently develop and/or assess Business Cases, perform feasibility studies, develop action plans related to Processes Improvements, Costs and/or Quality improvements is preferred, and the ability to develop and access a network of Subject Matter Experts is preferred. Strong communication and leadership skills are highly preferred. This position will require up to 70% domestic and international travel.
Primary Location:North America-United States-New Jersey-Raritan
Organization: JANSSEN SUPPLY GROUP, LLC (6046)
Job Function: R&D Engineering (R&D)
Certain sites within the Johnson & Johnson family of companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.