General Assignment Summary (Longer Term Contract Position)
For specific projects:
General Work activities
- Help develop cell and gene therapy (CGT) processes by performing critical review of methods for plasmids and other CGT raw materials
- Provide Subject Matter Expertise and technical management to manage completion of raw materials analytical methods and specifications activities for CAR-T and gene therapy products.
- Design and create plasmid stability protocols, characterization protocols, reports, and other technical documentation like abstracts and memos
- Assist in regulatory filings by reviewing documents and adding content as needed for raw material and plasmid method descriptions
- Manage the approval workflows of technical documents in the document management system
- Analyze data generated by contract research organizations (CROs) and summarize in documents as required
- Learn the concepts of new techniques in order to assist in method development and validations at CROs
- Manage sample submissions to CROs
- Request quotes from CRO project managers (PMs) and submit for purchase orders (POs) internally
- Ensure lab personnel aliquots and ships samples
Candidate Skills
- Knowledge in CGT sector
- Very organized, attention to detail
- Be able to independently manage multiple projects and responsibilities at one time
- Keep detailed notes on status of projects
- Update various spreadsheets recording sample submissions, testing, documentation
- Attend meetings and take notes as needed
- Present data as needed
Additional Considerations
- Knowledge of Next Generation Sequencing platforms a plus
- Plasmid experience a plus
Interested candidates should contact:
timothy.ramjit@pharmeridian.com and Robert.olivero@pharmeridian.com