Analytical CMC Leader

Bristol Myers Squibb New Brunswick , NJ 08903

Posted 5 days ago

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease.

Empowered to apply our individual talents and ideas so that we can learn and grow together. And driven to make a difference, from innovative research to hands-on community support. 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 the resources to pursue their goals, both at work and in their personal lives.

The Analytical Team Leader (ATL) is responsible for leading analytical project teams within Biologics Development. The team leader assures all biologics CMC analytical deliverables are met for 2-3 projects that initiate at clone selection and advance through BLA filing.

The analytical team lead will drive deep scientific knowledge of modality attributes that impact on process and product performance. These modalities may include mAb's, Pegylated Proteins, Viral and non-Viral Gene Delivery products. The analytical team leader works with a team of analytical scientists to define the analytical strategy, critical quality attributes, and a phase appropriate control strategy.

The team leader 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 integrated project team(s) and collaborates with partner functions such as 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.

Bristol-Myers Squibb is the industry leader in immuno-oncology with life-saving medicines such as Opdivo, Yervoy, and Empliciti and a rich clinical portfolio of diverse modalities including monoclonal antibody, fusion protein, gene delivery, and combination therapies.

Key Responsibilities:

The Analytical team leader will be directly accountable for managing delivery and timeline of analytical development activities at multiple sites in NJ and MA. This includes method development, structural and functional characterization, release testing, comparability, stability studies, regulatory filings, and related activities. The Lead will work closely with SME's and leaders across biologics development groups, to develop analytical strategy of the programs he/she is assigned.

Key Competencies/Qualifications:

  • PhD or MS in analytical science, biochemistry, pharmaceutical sciences, biology, or related discipline, plus at least 4 years of experience in Biologics CMC development

  • Proven leader with experience in managing matrix teams in a technical environment.

  • Strong program management and project management skills and adept at working collaboratively with cross functional teams

  • Strong experience with portfolio management & prioritization, resource modeling, and expertise with different tools like Timeline Maker, Tableau, spotfire are desirable.

  • Strong interpersonal and communication skills and knowledge of analytical and biochemical techniques, chromatography, biological function and biologics characterization

  • Experience in oversight of CMOs/CROs for biologics method development, characterization, technology transfer, and release

  • Knowledge of biologics CMC development from pre-clinical through clinical to commercialization

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Analytical CMC Leader

Bristol Myers Squibb