Cfdv
Principal Scientist or Sr. Principal Scientist - Analytical Development
Cfdv, New Brunswick, New Jersey, us, 08933
Principal Scientist or Sr. Principal Scientist - Analytical Development
Primary Location:
New Brunswick, New Jersey or Summit, New Jersey We are seeking an experienced leader with strong analytical technical skills and a passion for strategic project leadership, mentoring others, and driving technical innovation to solve challenging problems. This role will provide analytical subject matter expertise and analytical leadership within process development teams consisting of organic chemists, chemical engineers, and analytical scientists to support an increasingly complex portfolio of small molecules and milla-molecular (ADCs, peptides, oligonucleotides) drug candidates from phase 1 to commercialization. The successful candidate is expected to manage multiple projects, provide strategic leadership, and collaborate with stakeholders to move the portfolio through development to regulatory submissions. Overall responsibilities of this role may include: Coordinating the analytical activities in alignment with other project leads (process chemistry, engineering, technology, and supply) to enable process innovation and invention. Developing phase appropriate analytical control strategies and coordinating method development, validation, and transfer activities to support process development, internal/external campaigns, compliance needs, and regulatory submissions. Providing fit-for-purpose analytical methods and analyses which provide key insights and process knowledge for scale-up and process optimization studies for projects within the portfolio. Appropriate resource planning and activity coordination of internal and external work packages. Partnering with other Analytical Functions across the Product Development and Commercial organizations to integrate/align analytical strategies, build development knowledge, collect necessary analytical data, and significantly influence specification setting and IND/NDA submission content. Capability to adapt and grow within a dynamic environment including both internally and externally based development activities. Collaborate with SMEs/project team on innovative analytical approaches to solve challenging problems. Leverage technical expertise to drive problem solving and knowledge gathering. Seeking opportunities to influence/mentor other scientists in the team, the wider analytical community, or the external community (through consortia/guidance and publications) through lessons learned and workflow/practice enhancements. Accountable for identifying opportunities and/or implementing solutions to improve efficiency, productivity, and quality across various areas including: continuous processing, applying automation, screening, smart technology, and vendor interactions. The successful candidate is expected to significantly impact the advancement of the portfolio through their strong analytical technical skills, strategic leadership, and capability to manage multiple projects at various development stages. They are expected to grow into project leadership positions of increasing responsibility including the project leader for all drug substance development activities and become a significant influencer within our wider CMC development teams. Advancement along the technical ladder is also achievable through cross-functional problem solving and technology implementation/knowledge gathering that advance the portfolio. Qualifications/Requirements: Ph.D. or Masters in analytical, organic chemistry, or engineering is required. Proven track record and experience directly relevant to the role is critical to success. Experience in working across matrixed and/or externalized teams is highly desirable for Senior Principal Scientist position. 4+ years’ experience for Principal Scientist, and 6+ years’ experience for Senior Principal Scientist, in analytical development in the pharmaceutical industry. Experience in supporting API process development is preferred. Experience with late-stage registrational filings is a plus. Demonstrated expertise in a wide variety of analytical techniques is highly preferred. Demonstrated commitment to safety. Excellent interpersonal, time management, collaborative, team building, and communication skills are desired to ensure effective collaborations within matrix teams. Demonstrated performance against cooperation principles and enterprise mindset. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services, and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
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Primary Location:
New Brunswick, New Jersey or Summit, New Jersey We are seeking an experienced leader with strong analytical technical skills and a passion for strategic project leadership, mentoring others, and driving technical innovation to solve challenging problems. This role will provide analytical subject matter expertise and analytical leadership within process development teams consisting of organic chemists, chemical engineers, and analytical scientists to support an increasingly complex portfolio of small molecules and milla-molecular (ADCs, peptides, oligonucleotides) drug candidates from phase 1 to commercialization. The successful candidate is expected to manage multiple projects, provide strategic leadership, and collaborate with stakeholders to move the portfolio through development to regulatory submissions. Overall responsibilities of this role may include: Coordinating the analytical activities in alignment with other project leads (process chemistry, engineering, technology, and supply) to enable process innovation and invention. Developing phase appropriate analytical control strategies and coordinating method development, validation, and transfer activities to support process development, internal/external campaigns, compliance needs, and regulatory submissions. Providing fit-for-purpose analytical methods and analyses which provide key insights and process knowledge for scale-up and process optimization studies for projects within the portfolio. Appropriate resource planning and activity coordination of internal and external work packages. Partnering with other Analytical Functions across the Product Development and Commercial organizations to integrate/align analytical strategies, build development knowledge, collect necessary analytical data, and significantly influence specification setting and IND/NDA submission content. Capability to adapt and grow within a dynamic environment including both internally and externally based development activities. Collaborate with SMEs/project team on innovative analytical approaches to solve challenging problems. Leverage technical expertise to drive problem solving and knowledge gathering. Seeking opportunities to influence/mentor other scientists in the team, the wider analytical community, or the external community (through consortia/guidance and publications) through lessons learned and workflow/practice enhancements. Accountable for identifying opportunities and/or implementing solutions to improve efficiency, productivity, and quality across various areas including: continuous processing, applying automation, screening, smart technology, and vendor interactions. The successful candidate is expected to significantly impact the advancement of the portfolio through their strong analytical technical skills, strategic leadership, and capability to manage multiple projects at various development stages. They are expected to grow into project leadership positions of increasing responsibility including the project leader for all drug substance development activities and become a significant influencer within our wider CMC development teams. Advancement along the technical ladder is also achievable through cross-functional problem solving and technology implementation/knowledge gathering that advance the portfolio. Qualifications/Requirements: Ph.D. or Masters in analytical, organic chemistry, or engineering is required. Proven track record and experience directly relevant to the role is critical to success. Experience in working across matrixed and/or externalized teams is highly desirable for Senior Principal Scientist position. 4+ years’ experience for Principal Scientist, and 6+ years’ experience for Senior Principal Scientist, in analytical development in the pharmaceutical industry. Experience in supporting API process development is preferred. Experience with late-stage registrational filings is a plus. Demonstrated expertise in a wide variety of analytical techniques is highly preferred. Demonstrated commitment to safety. Excellent interpersonal, time management, collaborative, team building, and communication skills are desired to ensure effective collaborations within matrix teams. Demonstrated performance against cooperation principles and enterprise mindset. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services, and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
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