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Associate Director Biologics Method Lifecycle

Manufacturing/Ops

icon-location-marker Devens - MA - US
Posted 22 days ago Full_time R1518211

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

 

Join us and make a difference.  We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

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.

QUALIFICATIONS:

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.

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.