Manufacturing, Science and Technology

2 weeks ago

Rochester, United States Nucleus RadioPharma Full time
The Manufacturing, Science and Technology (MSAT) Specialist will play an essential role in driving collaboration between the research and development, manufacturing, training, etc. teams allowing for the introduction of new projects and transfer of existing projects from R&D to GMP facilities dedicated to theragnostic radiopharmaceutical manufacturing. This individual will perform tech transfer related and support function tasks including, but not limited to, the ordering and commissioning of new equipment/consumables and processes to meet sponsor requirements while also supporting operational readiness. The MSAT Specialist will also be responsible for training new and existing staff members on equipment and processes, while also assisting quality with any process deviations as a subject matter expert.

Description

PRINCIPAL RESPONSIBILITIES:

  • Proactively works cross-functionally with teams such as R&D, quality, and safety to onboard new equipment and processes for manufacturing of radiopharmaceuticals.
  • Ensures strict adherence to quality, safety, regulatory guidance, and written procedures in the manufacturing of final drug products in accordance with CFR (CGMP) guidelines, FDA, OSHA, and MN DHS.
  • Writes documentation such as, but not limited to user requirement specifications, system classifications, risk assessments, IQ/OQ/PQs, operational SOPs, batch records, training OJT/OJQs, logbooks, etc.
  • Develops and delivers phase appropriate product understanding and control strategies.
  • Working with Supply Chain individuals, orders consumables and spare parts needed for equipment and processes.
  • Assists with engineering/maintenance support.
  • Supports manufacturing of radiopharmaceuticals throughout the product lifecycle.
  • Demonstrates willingness to be flexible and adaptable to the needs of the department and business.
  • Ensures internal/external sponsor expectations are met or exceeded.
  • Works with Quality Assurance on investigations, deviations, root cause analysis, out of specifications, and/or non-compliance reports.
  • Ability to tech transfer equipment/processes to future facilities.
  • Drives optimization of production efficiencies and capabilities by creating material workflows, room layouts, while also developing continuous process improvements.
  • Performs other job-related duties as assigned.

Qualifications & Requirements

  • Bachelor’s degree in a STEM field such as chemistry, engineering, or biology required.
  • Minimum 5 years of relevant experience working in an FDA CGMP regulated environment with 21 CFR Parts 210 and 211 required.
  • Experience in aseptic processing and techniques required.
  • R&D and manufacturing experience in radiopharmaceutical development, formulation, and production is required.
  • Experience designing and writing documentation on hot cell functionality required.
  • Experience with industry standard automated synthesis units, dispensing units, and packaging automation required.
  • Strong mechanical aptitude and scientific background is required.
  • Must be capable of providing front line troubleshooting of manufacturing equipment and process issues and can properly elevate concerns and issues to appropriate personnel.
  • Superior teamwork, multi-tasking, and time management skills.
  • Excellent communications, interpersonal and collaboration skills, and ability to interact professionally with a wide range of individuals and organizations, both internal and external.
  • Ability to work independently with minimal direction, and drive deliverables through to completion by deadlines provided by Nucleus or sponsor.
  • Highly organized with strong attention to detail and commitment to high quality work.
  • Ability to work in a collaborative manner; identify challenges and barriers and recommend resolutions.
  • Excellent communication, analytical, problem solving, presentation and computer/pc skills including Microsoft Suite and related software.
  • Ability to travel up to 50%.
  • Must be able to visually discern, distinguish, inspect, assess, and observe quality of product daily.
  • Mechanical aptitude required; manual dexterity for manipulating small items; ability to lift 50 lbs. and to handle frequent crawling, stooping, crouching, and kneeling.
  • May be subject to respiratory fit tests to ensure job and environmental safety.

This job description is a summary of the typical functions of the position, not necessarily an exhaustive or comprehensive list of all possible position responsibilities, tasks and duties. The company reserves the right to assign or reassign duties and responsibilities to this job at any time. This job does not constitute a written or implied contract of employment; employment remains “at-will”.

Nucleus RadioPharma is an equal opportunity employer and believes everyone deserves respect, dignity and equality. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

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