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

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Project Leader (Help Desk Supervisor)

Rutgers University

Posted 4 days ago

VIEW JOBS 10/18/2019 12:00:00 AM 2020-01-16T00:00 Rutgers, The State University of New Jersey is seeking a Project Leader for the Information Services department at Rutgers, University Behavioral Health Care. The Project Leader is responsible for supervising the Helpdesk and associated staff, as well as implementation, maintenance of hardware and software systems required for support of users of desktop information systems and mobile devices. Among the key duties of this position are the following: * Acts as the Helpdesk for all technical questions about systems hardware and software. Acts as a subject matter expert for applications for which unit delegated administrators are required for support (Office365, Duo, Box, etc.). * Acts as the resource to end-users for problems encountered with desktop systems, network hardware, software and applications. * Works with information security, software development and server systems analysts to provide resource planning, access and environment changes and implements mitigation strategies needed to put them into production. * Integrates systems and network tools and monitoring with appropriate Helpdesk staff training to provide to the Helpdesk a continuous status of health assessment of UBHC information resources allowing the Helpdesk operations and productivity needed to maintain appropriate, reliable and up-to-date service to UBHC. Rutgers University New Brunswick NJ

Analytical CMC Leader

Bristol Myers Squibb