POSITION SUMMARY:
The Manufacturing 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. This will be done by following current good manufacturing practices (CGMP), established standard operating procedures (SOPs), safety requirements, and quality processes to meet sponsor requirements.
The Manufacturing 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. The Manufacturing Specialist will be responsible for scheduling and coordinating production runs with team members as well as writing and conducting on the job trainings.
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 CGMP, SOPs, 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.
- Writes documentation and trainings as needed to ensure operational success.
- Assists in scheduling manufacturing activities and team member staffing to support a 24/7 manufacturing environment.
- Coordinates manufacturing schedules, inventory management, equipment maintenance, and training and development of other manufacturing technicians.
- Maintains inventory of materials and consumables.
- 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.
- Works with Quality Assurance on investigations, deviations, root cause analysis, out of specifications, and/or non-compliance investigations.
- Performs other job-related duties as assigned.
QUALIFICATIONS & REQUIREMENTS:
- 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 2 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.
- Experience working with hot cells and automated processing equipment strongly preferred.
- 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.
- Ability to support 24-hour manufacturing and may require nights, weekends, and/or the ability to work overtime when necessary.
- 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.
- Mechanical aptitude required; manual dexterity for manipulating small items; ability to lift to 50 lbs. and to handle frequent crawling, stooping, crouching, and kneeling.
- Must be able to visually discern, distinguish, inspect, assess, and observe quality of product daily.
- May be subject to respiratory fit tests to ensure job and environmental safety.
- Ability to work in a cleanroom and sterile compounding environment, adhering to strict health and hygiene standards to ensure the safety and quality of drug products.
- Must report any health conditions (e.g., rashes, active infections) that could impact product integrity or contamination risks.
- Chronic health conditions that prevent long-term performance of essential job functions may require evaluation and could affect employment status.
- Proper garbing and personal hygiene must be maintained at all times when in the cleanroom or compounding areas.
- Normal near visual acuity (20/20 with or without corrective lenses) and no impairment of color vision.
- Testing for visual acuity and color discrimination required.
THE FINE PRINT:
The salary range in Minnesota is $75,000 to $90,000 per year. Please note that compensation may vary outside of this range depending on several factors, including but not limited to a candidate's qualifications, skills, competencies, experience, and location.
Benefit packages for this role include medical, dental, and vision insurance, as well as a Health Savings Account or Flexible Spending Account options (depending on the plan chosen), and 401k retirement account access with employer matching. Team members in this role are also entitled to paid sick leave and/or other paid time off in compliance with applicable law. Relocation is available to qualified team members.
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.