Scientist I, Analytical Dev, Biologics

Employer
Celgene
Location
Cambridge, MA, US
Posted
Oct 06, 2018
Ref
1803424
Required Education
Masters Degree/MBA
Position Type
Full time
Other Locations:US- MA- Cambridge

Description

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

Scientist I, Analytical Development, Biologics
Summit, NJ

SUPERVISOR

Associate Director, Analytical Development

DEPARTMENT

Biologics Development and Manufacturing

PREREQUISITES

MS or PhD in Analytical Chemistry or related science or engineering field

Minimum of 2 years (PhD) or 6 years (MS) of industry experience

Position Summary:

This is a key role within Biologics Analytical Development at Celgene. The role carries responsibility for managing analytical development deliverables for late-stage molecules. The incumbent will be responsible for independently execute on analytical strategy for assigned projects, including but not limited to control strategy, comparability, and analytical tech transfer. The individual is anticipated to take on increasing responsibilities as the Biologics portfolio and organization expands.

Responsibilities Include:
  • Participate effectively as a member of project teams within Celgene and with external organizations
  • Responsible for design, review, and approval of protocols and overseeing of study execution and data generation.
  • Transfer analytical methods to contract testing laboratories worldwide
  • Guide development, optimization, and validation of analytical methods both internally and at contract testing laboratories
  • Manage analytical development-related operations and communications with external manufacturing sites and contract testing laboratories to advance analytical development activities
  • Review analytical data for completeness and correctness and initiate or support investigations
  • Write formal reports in support of regulatory filings and appropriate responses to questions from regulatory authorities
  • Interact effectively and transparently with functional leads within the Biologics Development & Manufacturing department and with other Celgene stakeholders in Quality, Regulatory CMC, and Project Leadership
  • Timely communication of progress and escalation and management of risks
  • Share responsibility for the department's scientific and technical standards and critical review of documentation
  • Maintain currency with applicable global regulations and industry standards for analytical testing and characterization of recombinant protein products


Skills/Knowledge Required:
  • MS or PhD in Analytical Chemistry or related scientific or engineering discipline
  • At least 2 years (PhD) or 6 years (MS) of biopharmaceutical industry or CDMO experience, with focus on analytical development of glycoprotein and other protein-based therapeutics
  • Demonstrated experience with development and troubleshooting of physicochemical methods for recombinant proteins (SEC, CE-SDS, etc.).
  • Experience in working with contract laboratories for method development, qualification, validation, and transfer
  • Strong problem-solving skills and demonstrated ability for critical and creative thinking
  • Excellent grammar and communication skills, both oral and written
  • Proven leadership ability to align and motivate stakeholders and coworkers


Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.