Production Pharmacist

Fagron•Canton, MA

About The Position

The Production Pharmacist works alongside room supervisors and senior technicians to oversee activities involved in preparing materials and manually aseptically filling compounded sterile products in an ISO 5 VLFH within an ISO 7 environment. The role provides on-the-floor leadership to the production team and supports compliance, quality, training, and process improvement in the manufacturing suites.

Requirements

Graduated from an accredited college of pharmacy.
Licensed Pharmacist in Massachusetts.
Experience in a leadership position or demonstrated leadership abilities.
Solid math and effective problem-solving skills, with demonstrated use of sound judgment.
Good verbal and electronic communication skills and strong organizational and interpersonal skills.
Ability to work effectively and lead a team.
Ability to work positively and professionally with others and develop and maintain strong working relationships with coworkers and management.
Ability to take initiative, ask for and offer help when needed, and work independently without prompting.
Strong attention to detail and focus on quality, accuracy, and accountability.
Ability to stand and maneuver around tight cleanroom spaces for upwards of seven hours per day.

Nice To Haves

Additional state pharmacist licenses.
Experience working in a regulated/GMP environment.
Good working knowledge of appropriate cleanroom behavior and aseptic technique.

Responsibilities

Pass and maintain gowning qualification for entrance into ISO 7 cleanrooms.
Pass media fill and maintain qualification to assist with tasks in the ISO 5 VLFH as required.
Assist in overseeing ISO 7 cleanroom activities, including VLFH cleaning; preparation of materials for aseptic reconstitution, pooling, and dilution of drug product; manual aseptic filling; calibration checks; and environmental monitoring plating of operators.
Assess situations rapidly, troubleshoot production concerns, guide operators, and communicate complex detailed information to management outside the cleanrooms through electronic tools.
Ensure compliance with SOPs, batch records, and HR policies, and assist with disciplinary action as needed.
Meet Right First Time (RFT) metrics by reducing errors and deviations and completing corrections promptly.
Review and maintain adherence to manufacturing schedules.
Track employee training to ensure compliance.
Assist with bi-annual reviews of procedures.
Provide on-the-floor leadership to the production team.
Coach and train technicians in the manufacturing suites.
Support departmental process-improvement and scale-up initiatives.
Obtain and retain additional state licenses as required.