百时美施贵宝中国官方微信号
Associate Director- Analytical Development

Manufacturing/Ops

icon-location-marker Devens - MA - US
Posted 24 days ago Full_time R1518199

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.

The Associate Director will lead a team of scientists in advancing analytical development and managing analytical CMC development activities. the position is  one of the key leadership roles in biologic development organization in supporting programs from late stage biologic development all the way to BLA filing.

Functional responsibilities include leading a team of scientist for analytical assay development, analytical control strategy setting, managing external/internal testing labs,  advancing analytical technology, managing and mentoring junior analytical technical leads in analytical CMC strategic planning and program management. This role will be based in Devens MA.

The candidate will actively work with the process development team, analytical characterization team, early assets analytical development team, Manufacturing Science & Technology, Data Analytics, Project Management, and quality groups in a matrix, team organization to establish best in class analytical development organization, ensuring scientific excellence and high quality standards

The successful candidate should be self-motivated, have excellent communication and leadership skills, be a team leader, and have broad knowledge and experience in protein chemistry and bioanalytical techniques including chromatographic and electrophoretic separations for both product quality and process impurity analysis. Desired skills include Design of Experiment (DoE), HPLC/UPLC, LC-MS, Capillary Electrophoresis, SDS-PAGE, ELISA, iCIEF, protein particle analysis, glycan and PTM analysis. Knowledge and experience with protein / peptide characterization and molecular and cell biology would be a plus.

This role will be located in Devens, MA.

The successful candidate will have

  • PhD in Chemistry, Biochemistry or Protein Chemistry with Minimum of 10 years of experience in Biologic Analytical Development
  • Track record of successful implementations of a robust analytical assays and technology from development to a commercial setting
  • Track record of demonstrable management skills of multiple projects
  • Experience in managing scientific staffs
  • Extensive technical experience in modern analytical techniques for biologic testing, including HPLC, UPLC, CE-SDS, iCE, Gel Electrophoresis, ELISA, LabChip® for multiple protein modalities.
  • Experience with GMP regulation, ICH guidelines and regulatory filings
  • Experience in technical transfer of commercial assays
  • Experience with mass spectrometry and biophysical characterization is a plus.
  • Experience with PCR, ELISA, Western Blotting, Cell based bioassay is a plus.
  • Experience in design of experiments and basic statistical knowledge is desirable.
  • Demonstrate excellent communication and interpersonal skills leading projects in a matrix organization.

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.