Manager, Pharma ManufacturingScientific Search • Rochester, MN, US
Manager, Pharma Manufacturing
Scientific Search • Rochester, MN, US
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job_description.job_card.job_descriptionBachelor'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. Mid-Senior level Full-time Management and Manufacturing Staffing and Recruiting
Overview
Manager, Pharma Manufacturing — onsite in Rochester, MN (Relocation assistance provided).
Responsibilities
- 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.
Qualifications
If you would like to learn more about this great opportunity, please reach out to Kiera@ScientificSearch.com and reference job# 19477.
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Manufacturing Manager • Rochester, MN, US