Contract - Biologics CMC Analytical Development
- Employer
- Global Blood Therapeutics
- Location
- San Francisco, CA, United States
- Start date
- Apr 15, 2021
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- Discipline
- Information Technology, Business/Data Analytics, Science/R&D, Biotechnology, CMC
- Required Education
- Other
- Position Type
- Full time
- Hotbed
- Biotech Bay
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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:
Qualifications:
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
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