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.
- Completion of media bi-annual media fill and fingertip testing (as applicable per site)
- Knowledge of FDA and EU regulations preferred
- Proven pharmaceutical experience of minimum 1-2 years
- Proven record keeping skills with extreme attention to detail
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.
- Review and understand study protocol requirements in regard to investigational product handling.
- Active member of study team providing expertise and support such as evaluating study feasibility, study set up and conduct, participating in internal and/or external client meetings.
- Provide internal and/or external client communication and interaction regarding investigational product handling and protocol specific requirements.
- Maintain aseptic compounding evaluation requirements.
- 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.
Other
- Registered Pharmacist required
- Doctor of Pharmacy preferred but not required
- Requires flexible work hours, namely for occasional on-call weekend availability
- Celerion Values: Integrity Trust Teamwork Respect
- All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability.
