Manager, Pharma Manufacturing

Overview

Manager, Pharma Manufacturing — onsite in Rochester, MN (Relocation assistance provided).

• Lead manufacturing operations of theragnostic radiopharmaceuticals.
• Oversee production staff and provide leadership to meet company goals and drive a client-focused business.
• Ensure production activities comply with FDA, cGMP, DHS radiation safety, and other applicable federal, state, and local regulations; manage product release.
• Coordinate production schedules to meet customer orders and demand.
• Hire, train, develop, and manage the performance of production team members, including goal setting, performance reviews, and conflict resolution.
• Assist in inventory management, facility maintenance, equipment maintenance, and calibrations as needed.
• Operate production equipment and chemistry modules of moderate complexity for novel radiopharmaceutical production.
• Assist in root cause analysis of production and/or QC failures including out-of-specification and non-compliance investigations.
• Collaborate with cross-functional teams to develop novel radiopharmaceuticals for clinical production at the Minnesota Facility.
• Work with quality control, micro, procurement, radiation safety, and other teams to ensure products are shipped right first time.
• Design and procure production equipment and consumables needed for current and future client processes.
• Develop SOPs, logbooks, training/qualifications, and validation documentation for production of radiopharmaceuticals.

• Bachelor’s degree in STEM or equivalent combination of education and experience required.
• Familiarity with GMP manufacturing environment and FDA cGMP regulations required.
• 3-5 years of radiopharmaceutical production experience required.
• Experience in aseptic processing and techniques required.
• Strong teamwork, multi-tasking, and time/project management skills.
• Proven organizational and decision-making abilities to prioritize competing work and meet deadlines while upholding quality standards.
• Technical aptitude for evaluating and procuring equipment needed.

If you would like to learn more about this great opportunity, please reach out to  and reference job# 19477.

• Mid-Senior level

• Full-time

• Management and Manufacturing

• Staffing and Recruiting