Scientist, Assistant Analytical Team Lead (R1560220-en-us)
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.Position: Scientist, Assistant Analytical Team LeadLocation: Cambridge, MA or Devens, MA or New Brunswick, NJ or Summit, NJ
The Assistant Analytical Team Lead is responsible for assistance leading analytical project teams within Biologics Development. The Assistant Analytical Team Lead coordinates all analytical activities, support development of the analytical strategy for Biologics development programs, assist with establishing the analytical development timeline, and participates in management of matrix teams to support overall CMC development. The Assistant Analytical Team Lead assures all biologics CMC analytical deliverables are met for 2-3 projects that initiate at clone selection and advance through BLA filing. The Assistant Analytical Team Lead will drive deep scientific knowledge of modality attributes that impact on process and product performance. These modalities may include mAb’s, fusion proteins, ADCs, cell therapies, Viral and non-Viral Gene Delivery products. The Assistant Analytical Team Lead works with a senior Analytical Team Lead and with a team of analytical scientists to define the analytical strategy, critical quality attributes, and a phase appropriate control strategy. The individual may be required to help design in-vivo studies where necessary to drive knowledge of attribute impact on PK, efficacy, or toxicity. This individual may also represent the analytical function in the CMC team(s) and collaborate with partner functions such as discovery, process development, formulation development, quality, regulatory, manufacturing and supply chain. Close partnership with process, formulation and other analytical functions and leaders is essential to develop innovative and robust processes and products.
The Assistant Analytical Team Lead will be supporting senior Analytical Team Leadership accountable for managing delivery and timeline of analytical development activities at multiple sites within BMS and with external contract manufacturing and testing laboratories. Direct responsibilities will include oversight over method development, structural and functional characterization, release testing, comparability, stability studies, regulatory filings, and related activities. The Assistant Analytical Team Lead will work closely with SME’s and leaders across biologics development groups, to develop the analytical strategy of the programs assigned to this individual.
Qualifications & Experience
- PhD or MS in analytical science, biochemistry, pharmaceutical sciences, biology, or related discipline, plus 0-5 years of experience in Biologics CMC development
- Knowledge of analytical and biochemical techniques, chromatography, biological function, protein higher order structure, and biologics characterization
- Experience resolving analytical technical issues and challenges
- Exceptional interpersonal and communication skills
- Experience working collaboratively with cross functional teams
- Exposure to managing matrix teams in a technical environment
- Knowledge of biologics CMC development from pre-clinical through clinical to commercialization would be a plus
- Experience or drive to excel in program management and project management
- Experience in oversight of contract manufacturing organizations (CMOs)/contract research organizations (CROs) for biologics method development, characterization, technology transfer, manufacture and release is a plus
- Experience or drive to excel with portfolio management & prioritization, resource modeling, and expertise with different tools like Timeline Maker and Tableau
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
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