You are applying for a position through Medix, a staffing agency. The actual posting represents a position at one of our clients.
Job Summary
The Production Manager will play an essential role in leading manufacturing operations of theragnostic radiopharmaceuticals. This position will oversee production staff in addition to providing leadership to meet company goals and lead a company-focused business.
Key Responsibilities
- Oversees production activities ensuring products are produced, analyzed, and released according to FDA, cGMP, DHS radiation safety, and other applicable federal, state, and local regulations.
- Manages and coordinates production schedules to meet customer orders and demand.
- Hires, trains, develops, and manages the performance of production team members, including setting goals, performance reviews, and conflict resolution.
- Assists in inventory management, facility maintenance, equipment maintenance, and calibrations.
- Operates production equipment and chemistry modules of moderate complexity for novel production of radiopharmaceuticals.
- Assists in root cause analysis of production and/or QC failures including out of specification and non-compliance investigations.
- Collaborates with team members and principal investigators to develop novel radiopharmaceuticals for clinical production.
- Works cross-functionally with quality control, micro, procurement, radiation safety, etc. to ensure products are shipped correctly the first time.
- Designs and procures production equipment and consumables needed for current and future client processes.
- Develops process and equipment standard operating procedures, logbooks, training/qualifications, and validation documentation for the production of radiopharmaceuticals.
- Performs other job-related duties as assigned.
Qualifications
- Bachelor’s degree in a STEM field and/or equivalent combination of education and experience/training required.
- Familiarity with a GMP manufacturing environment and working with FDA cGMP regulations required.
- 3-5 years of radiopharmaceutical production experience required.
- Experience in aseptic processing and techniques required.
- Experience managing teams in a matrixed organization.
Experience
- 3-5 years of radiopharmaceutical production experience required.
- Experience in aseptic processing and techniques.
Skills
- Superior teamwork, multi-tasking, and time/project management skills.
- Demonstrated organizational and decision-making abilities to prioritize work assignments to meet deadlines and adhere to quality standards.
- Technical aptitude required for evaluating and procuring equipment.
- Excellent communication, analytical, problem-solving, and presentation skills.
- Proficiency with Microsoft Suite and related software.
Additional Requirements
- Ability to work varying shifts, including nights and weekends as required.
- Mechanical aptitude required; manual dexterity for manipulating small items; ability to lift up to 50 lbs. and handle frequent crawling, stooping, crouching, and kneeling.
- Minimal travel up to 10%.
- Ability to work in a cleanroom and sterile environment, adhering to strict health and hygiene standards.
- Must report any health conditions that could impact product integrity or contamination risks.
- Chronic health conditions affecting long-term performance of essential job functions may require evaluation and could affect employment status.
- Proper garbing and personal hygiene must be maintained at all times when in cleanrooms.
Medix Overview:
With over 20 years of experience connecting organizations with highly qualified professionals, Medix is a leading provider of workforce solutions for clients and candidates across the healthcare, scientific, technology, and government industries. Through our core purpose of positively impacting lives, we’re dedicated to creating opportunities for job seekers at some of the nation's top companies. As an award-winning career partner, Medix is committed to helping talent find fulfilling and meaningful work because our mission is to help you achieve yours.
