Radiopharmaceutical Manufacturing Manager

Job Title: Radiopharmaceutical Manufacturing Manager

FLSA Status: Exempt

Position Type: Full-Time Regular

Pay Type: Salaried

Reports To: Associate Director of Theragnostic Operations

PharmaLogic is the fastest-growing SPECT & PET radiopharmaceutical solutions provider and contract development and manufacturing organization (CDMO) with radiopharmacies across North America. We are passionate about expanding the power of radiopharmaceutical technology to provide transformative diagnostic and therapeutic agents to patients from bench to bedside.

PharmaLogic offers you an exceptional opportunity to join our dynamic team as a Radiopharmaceutical Manufacturing Manager!

If you have a passion for nuclear medicine and want to make a significant contribution to patient care while working in a stimulating and dynamic environment, then this opportunity is for you.

Job Overview:

As the Radiopharmaceutical Manufacturing Manager, you will play an essential role in leading site operations in routine manufacturing of radiopharmaceuticals. The position will oversee and train staff in the production of radiopharmaceuticals in addition to providing site leadership to meet company goals and leading a customer focused business.

Job Responsibilities and Duties:

Oversee and trains staff in the production of radiopharmaceuticals under 21CFR211 guidelines. From early phase up to and including commercial productions.

Operates a facility that meets FDA cGMP, NRC radiation safety, and other applicable federal, state, and local regulations.

Manages and coordinates production schedules to meet customer orders.

Trained and qualified in all aspects of cGMP production, and able to assist with production where required.

Hire, train, develop and manage the performance of staff.

Oversees inventory management, facility maintenance, equipment maintenance, and calibration.

Perform other job-related duties as assigned.

Job Requirements Skills Education:

Bachelor's Degree (B.S.) in an appropriate scientific or engineering field of study is required. Preferred fields of study include Microbiology, Biology, Medical Technology, Pharmacy, Biochemistry, or Engineering.

An advanced degree, in addition to the required science or engineering education, is a plus.

At least 5 years of work experience in pharmaceutical and/or medical device microbiology laboratories required with sterile/non-sterile pharmaceutical manufacturing preferred.

Familiarity with a cGMP manufacturing environment and working with FDA cGMP 21CFR211 guidelines required.

Experience managing teams in a matrixed organization. Supervisory experience preferred.

Experience with HPLC, radiochemistry synthesis, US FDA cGMP, Radiation Safety Principles, Isotopes production and analytical equipment troubleshooting and maintenance a plus.

Superior teamwork, multi-tasking and time/project management skills.

Excellent communication, analytical, problem solving, presentation and computer/PC skills (including proficiency in Microsoft Suite and related software).

Ability to work varying shifts.

Required are a mechanical aptitude; manual dexterity for manipulating small items; ability to lift between 16 to 50 lbs. and to handle frequent crawling, stooping, crouching and kneeling; ability to analyze situations, set priorities and meet deadlines while maintaining attention to detail in a fast-paced and dynamic environment; effective organizational skills; a commitment to continuous learning.

An ability to work well both independently and as part of a team

Come join our winning team and begin a fulfilling career with us by applying today.

PharmaLogic is an Equal Opportunity Employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other protected class.

Benefits Include:

401(k) retirement benefit program

Medical

Dental care

Disability insurance

Employee assistance program

Life insurance

On-site parking

Paid time off

Vision care