The Analytical project leader (AL) role will be responsible for developing effective collaborations within CSD project teams consisting of organic chemists, chemical engineers, and analytical scientists to support of an increasingly complex portfolio of small molecules and milla-molecular (ADCs, peptides, oligonucleotides) drug candidates.
Partners with organic chemists and chemical engineers to strategically developing effective control strategies to support drug substance processes, as well as process knowledge and data needed to ensure health authority acceptance of regulatory filings.
Accountable for 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.
Accountable for collaborating within project teams to provide innovative analytical approaches to help solve challenging problems encountered to support route selection and process optimization studies conducted by chemists and chemical engineers.
Accountable for developing and transferring methods to other analytical release functions to support the timely release of clinical API batches.
Partners with other Analytical Functions within Chemical & Synthetics Development (CSD), and across Product Development to evolve, integrate and optimize analytical support to create a world-class analytical function.
Successful candidates expected to grow and advance to become overall project leads of CSD project teams.
Specific accountabilities and responsibilities include the following:
Accountable for strategically driving project development as Analytical Leader across CSD (i.e., effectively plan/manage workload, assess and manage appropriate project risks without being overly risk adverse, develop appropriate control strategies, and collaborate with chemists/engineers). Embraces evolving expectations in AL role such as increased emphasis on risk acceptance, embracing variabilization approaches, and effectively collaborating with organic chemists & chemical engineers to provide strategic impact to the projects.
Responsible for willingly and enthusiastically working at the bench to solve challenging analytical problems, especially when problems arise and resources are not readily available.
Accountable for developing focused presentations which highlight the project strategy and risks, and effectively presenting project strategy at CSD Governance meetings (Office Hours, PL Forum, and Team Meetings) and other project forums.
Demonstrated skill and ability to influence initiative(s) which improve efficiency, productivity, and alignment within CSD. Within teams, is routinely active in discussion, both defines and agrees to action items, and delivers within timelines with high quality.
Partner with other subject matter experts to continually develop knowledge and capability amongst CSD organic chemists and chemical engineers to perform routine separations analyses across CSD.
Ph.D. or Masters in analytical or organic chemistry is required. Practical experience directly relevant to the role is critical to success and minimum degree requirements change relative to experience.
Experience with coordinating/leading analytical teams and support of projects is highly desired.
Minimum of 5 years of experience in analytical problem solving in the pharmaceutical industry. Experience in supporting API process development highly preferred.
Demonstrated expertise in chromatographic separations a must. Experience with supporting development of milla-molecular molecules a plus.
Demonstrated matrix leadership skills and capability to be effective within matrix teams.
Demonstrated commitment to safety.
Demonstrated ability to accept and adapt to change and proactively manage ambiguity and risk and make decisions in the absence of complete data.
Excellent interpersonal, collaborative, team building, and communication skills. Demonstrated performance against cooperation principles and enterprise mindset.
Bristol-Myers Squibb is a differentiated company, led by our unique BioPharma strategy that leverages the reach and resources of a major pharma company paired with the entrepreneurial spirit and agility of a biotech firm. We work every day to deliver innovative medicines for patients with serious and life-threatening diseases.