Pharmacist

Pharmacist

The Pharmacist provides operational pharmacy support, under the direction of the Head of Pharmacy, at a clinical development stage biopharmaceutical company. The Pharmacist will also support preparation of investigational doses for volunteers, meeting regulatory requirements for preparation of dose formulations under Good Clinical Practices (GCP) and in accordance with current pharmacy compounding best practices, including but not limited to, USP 797, 795, where applicable.

RESPONSIBILITIES:

• Reviewing and/or executing extemporaneous dispensing records, dosage and administration Instructions, core protocol elements, protocol, informed consent documents, Clinical Supplies Request
• Drafting pharmacy budget for each study
• Completing daily setup work in support of dose preparation activities
• Entering randomization data into electronic data capture management system
• Performing dummy run work to support verification of dose preparation
• Quality assurance role on dose preparations
• Pharmacy lead assignment on protocols
• Performing study closeout activities
• Maintaining accurate investigational drug inventories and supplies according to established policies and procedures
• Maintaining accurate control, accountability and distribution of controlled substances
• Dispensing investigational drugs to support clinical investigations
• Blinding of drug supplies
• Compounding and dispensing of oral, topical and parenteral dosage forms and matching placebo formulations
• Maintaining clinical supplies and compounding equipment
• Processing equipment/building repair requests

Qualifications

QUALIFICATIONS AND SKILLS NEEDED:

Qualifications needed are PharmD degree, CT State licensed pharmacist, at least 3 years of pharmacy practice experience in a setting preparing both sterile and non-sterile dosage forms, and completion of an accredited post-PharmD residency and/or fellowship. Math required.

Expertise in IV admixture per USP 797 required.

The successful candidate is expected to be competent in investigational drug management including protocol support activities; product development and formulation; investigational drug information development; and, control, storage, use, handling and accountability of investigational agents including controlled substances.

Must be detail-oriented and possess strong organizational skills and the ability to prioritize multiple tasks/projects.