Associate Director, Analytical Sciences

Bristol-Myers Squibb Syracuse, NY

About the Job

Description:

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 Syracuse Biologics Manufacturing operation produces clinical, commercial and launch biologics drug substance at its 5000L scale manufacturing facility (mammalian cell process) in Syracuse, NY.

As an Associate Director you will join the technology enabling team which is responsible for the lifecycle management of separation methods (including transfer support, validation, methods’ performance monitoring and troubleshooting). This team resides within the analytical sciences and technology organization (AS&T), which supports manufacturing science and technology (MST) for commercial products. In addition to being responsible for the lifecycle management of commercial methods, AST is responsible for creating and managing the analytical CMC strategies from late stage development throughout the product lifecycle, validation strategy, authoring and reviewing regulatory filings, and supporting global QC and manufacturing technology groups. This position requires experience designing, planning & executing a broad range of experiments as well as analyzing data generated by many different assays. In this role the associate director will have responsibilities leading a team, participating in technical investigations, Health Authorities’ query responses, Post-Marketing Commitments/Follow Up Measures, contributing to authorship and review of technical documents and regulatory filings, and interfacing with health authorities as necessary.

Position Summary

As an Associate Director you will join the technology enabling team which is responsible for the lifecycle management of separation methods (including transfer support, validation, methods’ performance monitoring and troubleshooting). This team resides within the analytical sciences and technology organization (AS&T), which supports manufacturing science and technology (MST) for commercial products.  In addition to being responsible for the lifecycle management of commercial methods, AST is responsible for creating and managing the analytical CMC strategies from late stage development throughout the product lifecycle, validation strategy, authoring and reviewing regulatory filings, and supporting global QC and manufacturing technology groups.

This position requires experience designing, planning & executing a broad range of experiments as well as analyzing data generated by many different assays. In this role the associate director will have responsibilities leading a team, participating in technical investigations, Health Authorities’ query responses, Post-Marketing Commitments/Follow Up Measures, contributing to authorship and review of technical documents and regulatory filings, and interfacing with health authorities as necessary.

Duties/Responsibilities

  • Function as a technical leader for analytical technical line and lead a group of scientists with a broad range of experience.

  • Define technical strategy and write/review associated documents to ensure global compliance for typical BioPharmaceutical’s analytical methods including HPLC, Gel and Capillary Electrophoresis, ELISA, Spectrophotometric and compendial methods.

  • Apply Health Authority best practices and expectations in all work activities.

  • Partner with analytical development to achieve method readiness to initiate validation, write technical protocols, gather and interpret data generated by analytical development/QC labs and write/review technical reports.

  • Support methods’ validation and transfers within and outside of BMS.

  • Conduct periodic method validation and performance reviews and work with team leader to design and execute remediation experiments and implement changes to new or existing commercial methods.

  • Work collaboratively across organization and sites for method readiness, transfer, performance and trouble shooting in commercial environment.

  • Work closely with all AS&T team members to understand and support their deliverables to achieve organization goals.

  • Manage scientists involved in technical support and method lifecycle (including late stage development evaluations, validation, transfers and maintenance).

  • Manage analytical support activities and resourcing, including process and product related impurity analyses.


Qualification:

Specific Knowledge, Skills, Abilities, etc\:

  • Demonstrated experience and in depth technical knowledge of methods used for BioPharmaceuticals testing and characterization, validation, transfer and lifecycle of analytical methods used in late stage/commercial biologics process development and/or manufacturing environment.

  • Hands on expertise in assays used to test and characterize biological products (e.g. HPLC, Gel and Capillary Electrophoresis, compendial methods, ELISAs, Mass Spectrometry, etc.). 

  • Extensive familiarity with regulatory guidelines, compendia and cGMP laboratory processes.

  • Experience working with colleagues at remote sites.

  • Strong written and communication skills, excels at working in a matrix organization.

  • Strong decision making skills

Education/Experience/ Licenses/Certifications\:

  • PhD in biological sciences, chemistry or related scientific disciplines with > 10 yrs. relevant experience.

  • MS or BS with > 15 yrs relevant experience.

  • Industry experience in method lifecycle for the development and/or commercialization of Biopharmaceuticals.

Physical Demands\:

  • This role requires office work, biochemical laboratory work, computer work, group meetings, and thus involves the following

  • Sitting, standing, walking, working with analytical instruments, repetitive motion including bending and lifting small containers/equipment

Work Environment\:

  • This role requires office work, teleconferencing, computer work, leading meetings and thus involves the following

  • Working in open office environment, working in laboratory, working alone, working with/around others

Travel\:

  • This position may require approximately 30% travel.

Supervisory Responsibilities\:

  • Requires supervisor duties.