A rapidly growing immuno-oncology based organization is looking to add to their incredible team! With the development of a potentially first-in-class oral dosage drug which addresses a fundamental biologic mechanism of immune suppression in cancer in multiple clinical studies, this bioscience organization is absolutely booming! While establishing a fun, innovative, and inviting culture, this companies dedication to advancing novel medicines for people with cancer speaks volumes!
- Continuous CMO oversight.
- Review and approve manufacturing batch production and analysis records in support of drug substance, drug product and finished product disposition
- Provide QA guidance and recommendations in a professional and collaborative manner to internal and external stakeholders.
- Release finished goods (drug substance, drug products, and placebos) for use in clinical trials and ultimately commercial sale.
- Generate targeted metrics for review
- Review/Approve batch records, protocols, analytical results, and documents associated with investigations, OOS results, deviations, and corrective/preventive actions.
- Conduct internal audits, track progress, and trend results as well as participating in relevant supplier audits
- Review/Approve Change controls and provide guidance on GMP Manufacturing
- Support Annual Product Review report generation and approval
- 5 Years of experience in QA GMP
- Ability to manage in a fast-paced environment
- Working knowledge of relevant FDA, EU, MHRA, ICH guidelines
- Experience working with CMOs, vendors, and small molecule products
- Excellent judgment and ability to communicate complex issues in an understandable way.
- Ability to effectively collaborate in a cross-functional environment