Careers

Position Overview:

Supervise the operations of the Investigational Drug Repository (IDR) to ensure compliance with all regulations related to the handling and storage of investigational drugs (ID) according to labeling requirements. Responsibilities include:

• Reviewing draft batch records related to production, packaging, and labeling to ensure drug safety.

• Preparing and executing packaging and labeling activities for batch records.

• Developing manufacturing procedures for packaging and labeling, as well as corresponding standard operating procedures (SOPs).

• Ensuring that all packaging and labeling operations are conducted in accordance with regulatory standards, including cGMP regulations and internal SOPs.

• Coordinating with pharmacies, drug distributors, and vendors to procure investigational drugs and study-related supplies.

• Monitoring the release and approval of packaging components prior to their use in the packaging and labeling facility.

• Participating in study initiation by reviewing protocols, collaborating with stakeholders, estimating drug and supply needs, gathering packaging and labeling requirements, and designing label formats and packaging configurations.

• Keeping current with federal, state, and local regulatory changes related to the operation and maintenance of the IDR and the Pharmaceutical Research Laboratory (PRL), and ensuring continued compliance.

Requirements:

• Must hold a Maryland State Pharmacist license.

• Master’s degree or foreign equivalent in Pharmacy, Health Informatics, or a closely related field.

• At least 1 year of experience as a Staff Pharmacist, Pharmacist, or an equivalent role.

Application Instructions:

Please mail your résumé to the following address:
Eminent Services Corp
7495 New Technology Way
Frederick, MD 21703