Bristol Myers Squibb Senior Principal Scientist, Analytical Team Lead in Devens, Massachusetts
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.
The Analytical Team Lead (ATL) is responsible for leading analytical project teams within Biologics Development. The Analytical Team Lead coordinates all analytical activities, develops the analytical strategy, establishes the analytical development timeline, and manages matrix teams to support overall CMC development. The ATL assures all biologics CMC analytical deliverables are met for 2-3 projects that initiate at clone selection and advance through BLA filing. The ATL 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 Analytical Team Lead works with a team of analytical scientists to define the analytical strategy, critical quality attributes, and a phase appropriate control strategy. The ATL is responsible for project planning and assures both timeliness and high quality of deliverables. 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 also represents the analytical function in the CMC team(s) and collaborates with partner functions such as discovery, process development, formulation development, quality, regulatory, manufacturing and supply chain. Close partnership with process and formulation team leaders is essential to develop innovative and robust processes and products.
The Analytical Team Lead will be directly accountable for managing delivery and timeline of analytical development activities at multiple sites within BMS and with external contract manufacturing and testing laboratories. This includes method development, structural and functional characterization, release testing, comparability, stability studies, regulatory filings, and related activities. The ATL will work closely with SME’s and leaders across biologics development groups, to develop the analytical strategy of the programs he/she is assigned.
Qualifications & Experience
PhD or MS in analytical science, biochemistry, pharmaceutical sciences, biology, or related discipline, plus at least 5-15 years of experience in Biologics CMC development
Proven leader with experience in managing matrix teams in a technical environment. Exceptional interpersonal and communication skills
Extensive experience and knowledge of analytical and biochemical techniques, chromatography, biological function, protein higher order structure, method development/validation and biologics characterization. Ability to apply innovative scientific approaches in support of development of analytical technical strategies
Exception knowledge of biologics CMC development from pre-clinical through clinical to commercialization. Including experience in regulatory filings (IND/BLA authoring) and addressing HA queries
Exceptional program management and project management skills and adept at working collaboratively with cross functional teams on multiple project assignment. Effectively able to manage conflicting resources and timelines using risk-balanced approaches
Exceptional experience with portfolio management & prioritization, resource modeling, and expertise with different tools like Timeline Maker and Tableau are preferred
Experience in oversight of contract manufacturing organizations (CMOs)/contract research organizations (CROs) for biologics method development, characterization, technology transfer, manufacture and release
Knowledge in the areas of viral therapy, AAV-based or other gene delivery platform is a plus
Experience with antibody-drug conjugates would also be a plus
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.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to firstname.lastname@example.org . Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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Company: Bristol Myers Squibb
Req Number: R1551597
Updated: 2022-01-23 01:47:12.204 UTC
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
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