Celerion is looking to solve the problem of swift and exceptional clinical research through translational medicine by getting drugs to market faster
Requirements
- Knowledge of relevant United States Pharmacopeia guidelines, including chapters 795, 797, 800, 1163, and 1168 as well as the FDA Guidance for Industry CGMP for Phase 1 Investigational Drugs required
- Maintain aseptic compounding evaluation requirements
- Knowledge of FDA and EU regulations preferred (if appropriate)
- Completion of media bi-annual media fill and fingertip testing (as applicable per site)
- Proven pharmaceutical experience of minimum 1-2 years
- Knowledge of United States Pharmacopeia guidelines, including chapters 795, 797, 800, 1163, and 1168 as well as the FDA Guidance for Industry CGMP for Phase 1 Investigational Drugs required
- Job-specific training is required and will be provided
Responsibilities
- Responsible for receipt, storage, preparation, disposition, and retention of all study investigational products in compliance with standard operating procedures, FDA, and DEA regulations concerning investigational product handling, accountability and security
- Act as a resource for study teams by utilizing pharmacological expertise and knowledge of pharmacy practice
- Provide training and monitoring for administration of investigational products as needed
- Review and provide input to standard operating procedures and training plans pertaining to pharmacy and assisting with pharmacy training as necessary
- Maintain pharmacy department equipment and applicable records as necessary
- Institutional Review Board consultant and resource
- Assist in training of new hires and students
Other
- Registered Pharmacist required
- Doctor of Pharmacy preferred but not required
- Proven record keeping skills with extreme attention to detail
- Requires flexible work hours, namely for occasional on-call weekend availability
- Celerion is an Equal Opportunity Employer
