PRODUCTION SPECIALIST

Apply for Production Specialist

The Production Specialist will play an essential role in manufacturing and production operations of theragnostic radiopharmaceuticals.

This individual will perform all manufacturing related tasks and support functions including, but not limited to, routine cleaning of rooms and equipment, reagent preparation, component assembly, formulation, dispensing, packaging, of radiopharmaceuticals and other duties as required, while following standard operating procedures (SOPs), safety, quality, and current good manufacturing practices (CGMP) to meet sponsor requirements.

The Production Specialist will operate as an independent contributor with decision making abilities, independent discretion and judgement while maintaining advanced knowledge of equipment and the manufacturing processes.

Description

PRINCIPAL RESPONSIBILITIES :

Leads and supports other team members in a fast-paced manufacturing environment

and setting, to include backing manufacturing goals, standards, mindsets, and behaviors both on and off the manufacturing floor.

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.

Performs routine cleaning of the manufacturing areas, setting up manufacturing

equipment, performing daily checks on various manufacturing equipment, and

operating of equipment in accordance with SOPs, cGMP, and aseptic technique.

• Follows all written procedures, verbal instructions, and communicates effectively, both written and verbally.
• Performs documentation and calculations in accordance with SOPs and CGMP guidelines.
• Operates manufacturing equipment and / or performs manual chemistry of moderate complexity for various phases of radiopharmaceuticals.
• Works cross-functionally with other team members such as R&D, quality, and safety to

develop and / or update SOPs for the manufacturing of radiopharmaceuticals.

Participates and performs effectively in a team environment. Proactively interacts with

cross-functional departments such as quality and safety to ensure the operational success of the manufacturing areas.

• Demonstrates willingness to be flexible and adaptable to the needs of the department and business.
• Takes initiative to achieve personal and departmental goals with quantifiable business results.
• Ensures internal / external sponsor expectations are met or exceeded.
• Coordinates manufacturing schedules, inventory management, equipment maintenance, and training and development of other manufacturing technicians.
• Works with Quality Assurance for investigations, deviations, root cause analysis, out of specifications, and / or non-compliance investigations.
• Performs other job-related duties as assigned.

MINIMUM QUALIFICATIONS :

• Bachelor's degree in a STEM field such as chemistry, engineering, or biology and / or an equivalent of relevant years of experience in the field 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.
• Manufacturing experience in radiopharmaceuticals, pharmaceuticals, biologics, or cell / gene therapy is 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, internal and external.
• Ability to work independently with minimal direction, and drive deliverables through to completion by deadlines provided.
• 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 support 24-hour manufacturing and may require nights, weekends, and / or the ability to work overtime when necessary.
• Ability to lift up to 50 lbs.
• Must be able to visually discern, distinguish, inspect, assess and observe quality of product on a daily basis.
• 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.