Contract - Biologics CMC Analytical Development

Location
San Francisco, CA, United States
Posted
Apr 15, 2021
Ref
1071
Hotbed
Biotech Bay
Required Education
Other
Position Type
Full time
CONTRACT - BIOLOGICS CMC ANALYTICAL DEVELOPMENT

Position Summary:

The consultant will provide biologics analytical expertise to support the development and QC related activities of inclacumab DS and DP.

Essential Duties and Responsibilities:

  • Provide strategic and scientific guidance as the large molecule analytical development expert on LCMS assays
  • Oversee analytical activities at CMOs for drug substance and drug product manufacturing including the troubleshooting/investigation of the analytical testing issues
  • Support Analytical Development, Quality, Manufacturing and Regulatory Affairs for LCMS related activities


Qualifications:

  • A degree Biochemistry, Chemistry, Chemical engineering or related discipline. PhD with minimum 10 years of experience is highly desirable
  • Must have hands-on experience in analytical method development, biochemical characterization
  • In-depth experience and knowledge in large molecule analytics. Must have experience in other CMC functional areas: Cell Culture, API Purification, Drug Substance and Drug Product
  • Broad knowledge of the biopharmaceutical industry, including in-depth operating knowledge of the processes and functions involved in biologics drug development and comparability assessment
  • Experience in recombinant protein submissions
  • Must have excellent problem-solving skills and verbal and written communication skills
  • Requires working knowledge of BLA submissions, Quality and regulatory requirements
  • Self-directed and proactive individual with ability to thrive in a fast-paced, entrepreneurial, dynamic environment with high performing colleagues
  • Comfortable executing on multiple projects independently