Job Description

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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