Contract - CMC Biologics Analytical

Location
San Francisco, CA, United States
Posted
Mar 26, 2021
Ref
1020
Hotbed
Biotech Bay
Required Education
Masters Degree/MBA
Position Type
Full time
CONTRACT - CMC BIOLOGICS ANALYTICAL

Position Summary:

This position will support analytical development, qualification and QC related activities of a monoclonal antibody at the contract manufacturing for Drug Substance and Drug product.

Essential Duties and Responsibilities:

  • Provide expert guidance on the large molecule analytical development, validation and establishment of specifications
  • Support project management activities for validation of analytical methods at CMOs for drug substance and drug product manufacturing
  • Perform data review and the investigation of the analytical testing/validation issues
  • Support Quality, Regulatory Affairs in preparing CMC section in regulatory filings


Qualifications:

  • A degree Biochemistry, Chemistry, Chemical engineering or related discipline. PhD with minimum 5 years of experience, MS with 10 years, BS with 15 years
  • In-depth experience and knowledge in large molecule analytics
  • Excellent project management skills
  • 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 IND/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