The Manager/Senior Scientist, Analytical Development will support the Pharmaceutical Development team at a novel pharmaceutical company focused on immuno-oncology for cancer treatments. This person will oversee the analytical activities for the drug substance and drug product programs.
Responsibilites:
- Lead method development and validation for Phase 3 and commercial stage drug products and substances
- Review data from testing in batch records and validation/stability reports
- Collaborate closely with the Quality Assurance (QA) department to create method validation reports and protocols, as well as to assist with deviations and investigations involving analytical testing
- Manage company's material programs at the CROs and CMOs
- Authoring analytical sections for IND filings
Qualifications:
- BS with 8+ years of relevant industry experience OR MS with 6+ years of relevant industry experience in a pharmaceutical or biotech company
- Hands on experience in a cGMP lab and drafting/reviewing documentation
- Strong background in analytical techniques for development of small molecules; including method development, method validation, statistical software
Benefits!
- Competitive base salary!
- Company stock options!
- Commuter benefits!
- Tuition reimbursement program!
- Generous PTO and holidays!
