Data Scientist

Boston, MA

Responsibilities

 

  • Review analytical release data to ensure all approved procedures were followed and all specifications were met for manufacturing.
  • Review protocols, reports and data associated with stability, method validation and method transfer.
  • Enter stability data into iStability and collaborate with the Quality team (Commercial Quality/IMP Quality) for review.
  • Evaluate for trends and ensure data is analyzed to help understand degradation pathways and to help develop specifications.
  • Assist with the management of the reference standards across all programs including review of protocols, data and CoAs generated.
  • Assure that source data and information is maintained and traceable.
  • Assist with CMC activities to support regulatory filings (IND, NDA, IMPD, MAA, CTA) for company development programs.
  • Work closely with other members of Pharmaceutical Sciences, the Quality Team (Commercial Quality/IMP Quality), and Regulatory to ensure the successful GMP manufacture of company clinical candidates and their successful progression through development to government filings
  • Support communication with external vendors via conference calls and/or emails, etc. as needed
  • Assist with non-compliance events and change controls for manufacturing support and testing with the Quality team (Commercial Quality/IMP Quality) for all company programs.
  • Assist as an analytical subject matter expert for CMO/CRO audits.

 

Requirements

 

  • At least a BS in Life Sciences or associated science degree mandatory
  • No less than three years of experience in Analytical or QC within the Pharmaceutical or Biotechnology filed in clinical or commercial setting
  • Hands on benchwork experience of general analytical techniques including: LC, GC, KF, dissolution, DSC, TGA, NMR, etc.
  • Previous experience with independent data review at peer level
  • Previous experience with non-conformances and change control is a plus.
  • Small molecule experience a plus
  • Knowledgeable in CGMP regulations and ICH or other industry guidance.

 

 

 

 

 

Note: Qualified candidates will be contacted within 2 business days of application. If an applicant does not meet the above criteria, we will keep your resume on file for future opportunities and may contact you for further discussion.

Date Posted 10/9/2020
Salary $55.00/hr






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