Manager Manufacturing

Overview

The Manager, Manufacturing 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 leading a company focused business.

• Oversees production activities by ensuring products are produced, analyzed, and released according to FDA, cGMP, DHS radiation safety, and other applicable federal, state, and local regulations.
• Manages and helps coordinate production schedules to meet customer orders and demand.
• Hires, trains, develops, and manages the performance of production team members. This includes setting goals, performance reviews, and conflict resolution.
• Assists in inventory management, facility maintenance, equipment maintenance, and calibrations among other tasks as needed.
• 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.
• Works with other team members and principal investigators to develop novel radiopharmaceuticals for clinical production at the Rochester, MN Facility.
• Collaborates cross-functionally with quality control, micro, procurement, radiation safety, etc. to ensure products are shipped right first time.
• Designs and procures production equipment and consumables needed for current and future client processes.
• Works cross-functionally with team members to develop process and equipment standard operating procedures, logbooks, training/qualifications, and validation documentation for production of radiopharmaceuticals.
• Performs other job-related duties as assigned.

• Bachelor’s degree in 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 in managing teams in a matrixed organization.
• Superior teamwork, multi-tasking, and time/project management skills.
• Demonstrated organizational and decision-making abilities to prioritize competing work assignments in order to meet deadlines and adherence to quality standards.
• Technical aptitude required for evaluating and procuring equipment needed.
• Excellent communication, analytical, problem solving, presentation and computer/pc skills including Microsoft Suite and related software.
• 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 to 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 to ensure the safety and quality of drug products.
• Must report any health conditions (e.g., rashes, active infections) that could impact product integrity or contamination risks.
• Chronic health conditions that prevent 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 the clean rooms.

The salary range in Minnesota is $,000 per year. Please note that compensation may vary outside of this range depending on several factors, including but not limited to a candidate’s qualifications, skills, competencies, experience, and location.

Benefit packages for this role include medical, dental, and vision insurance, as well as a Health Savings Account or Flexible Spending Account options (depending on the plan chosen), and 401k retirement account access with employer matching. Team members in this role are also entitled to paid sick leave and/or other paid time off in compliance with applicable law.

This job description is a summary of the typical functions of the position, not necessarily an exhaustive or comprehensive list of all…