Job Description

Manager, Pharma Manufacturing
(onsite in Rochester, MN-Relo assistance provided)
What You Can Expect To Be Doing
Leading manufacturing operations of theragnostic radiopharmaceuticals.
Oversee production staff in addition to providing leadership to meet company goals and leading a company focused business.
Oversee 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.
Manage and help coordinate production schedules to meet customer orders and demand.
Hire, train, develop, and manage the performance of production team members. This includes setting goals, performance reviews, and conflict resolution.
Assist in inventory management, facility maintenance, equipment maintenance, and calibrations among other tasks as needed.
Operate production equipment and chemistry modules of moderate complexity for novel production of radiopharmaceuticals.
Assist in root cause analysis of production and/or QC failures including out of specification and non-compliance investigations.
Work with other team members and principal investigators to develop novel radiopharmaceuticals for clinical production at the Minnesota Facility.
Collaborate cross-functionally with quality control, micro, procurement, radiation safety, etc. to ensure products are shipped right first time.
Design and procure production equipment and consumables needed for current and future client processes.
Work cross-functionally with team members to develop process and equipment standard operating procedures, logbooks, training/qualifications, and validation documentation for production of radiopharmaceuticals.
What you will bring to the table:
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.
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.
If you would like to learn more about this great opportunity, please reach out to Kiera@ScientificSearch.com and reference job# 19477.

Job Tags

Local area,

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