Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get 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.
- 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.
- Completion of media bi-annual media fill and fingertip testing (as applicable per site)
- Knowledge of FDA and EU regulations preferred (if appropriate)
Responsibilities
- Responsible for receipt, storage, preparation, disposition, and retention of all study drug products in compliance with standard operating procedures, EU, FDA, and DEA regulations (as applicable) concerning investigational product handling, accountability and security.
- Review and understand study protocol requirements in regard to investigational product handling.
- Preparation of study specific pharmacy manuals for any type of compounding studies.
- Ensure EU, Controlled Drug, and DEA license (if applicable) is current and all federal and state laws pertaining to prescription medications are being followed.
- Interact with all applicable regulatory agencies, as necessary, regarding investigational product and investigational product supply handling.
- Track and maintain appropriate pharmacy metrics as necessary, including retention follow up/invoicing.
- Document and report any and all pharmacy deviations and implement process improvement changes as applicable.
Other
- Responsible for staff management in accordance with the organization's policies and applicable laws.
- Responsibilities include interviewing, hiring, and training employees; planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems; development and coaching of employees
- Registered Pharmacist required
- Doctor of Pharmacy preferred but not required
- Proven pharmaceutical experience of minimum 1-2 years
