CDMO Product Development Technician I/Technician II

Overview

Accelerate your career with NorthStar!

NorthStar Medical Radioisotopes is seeking individuals with a desire to work within the pharmaceutical industry who possess an Intense Customer Focus, are Proactive and operate with Open-Minded Intelligence, a Can-Do Mindset and enjoy working in a highly Collaborative manner.  We are a growing, commercial-stage company focused on advancing patient care by providing therapeutic radioisotopes and novel radiopharmaceuticals to detect and treat cancer along with customized radiopharmaceutical development services.

At NorthStar, we prioritize professional growth of our employees. Working with our cutting-edge technology offers a stimulating and rewarding environment for talented individuals who want to be part of our exciting and growing business. We are committed to providing our employees with fulfilling work experiences and valuable career development opportunities. 

Innovative technology, opportunities for career advancement, and competitive compensation are just the beginning. NorthStar offers health and life insurance, 401K match, paid holidays, and paid time off, paid parental leave and all NorthStar employees are eligible on day one for our annual bonus and equity incentive plans.

Position

The CDMO Product Development Technician will provide support in NorthStar’s radiologic science laboratories within the CDMO Product Development Department. Responsibilities will include maintenance and support of laboratory controls, maintenance and calibration of equipment, manifestation and disposal of radioactive material, preparation of laboratory solutions, assistance with product development/production, and general laboratory maintenance.

The CDMO Product Development Technician II will have additional responsibilities, such as working independently and specializing in specialize in development, verification, and validation of current and/or new and existing radiopharmaceutical products/medical devices. 

Responsibilities

• Maintain and support specific laboratory controls including equipment calibration, radiologic assays, pharmaceutical compounding, solution preparation, inventory control, chromatography reagent preparation, and quality control testing.
• With appropriate supervision, perform routine and non-routine experiments and/or analyses following NorthStar procedures and guidelines. Ensure data is collected and documented according to good documentation practices.
• Perform tasks as needed to support product development. This may include solution preparation, equipment checks, and documentation preparation.
• Understand and execute the cradle-to-grave processes specific to all radioactive substances that are used in the laboratory including, but not limited, to DOT check in/check out process, waste management, and documentation/filing.
• Maintain low-level radioactive waste inventory management including: storage, manifestation, and disposal in accordance with regulatory requirements.
• Maintain supplies and manage inventory within the laboratory space.

The CDMO Product Development Technician II will have additional responsibilities, including:

• Perform routine and non-routine experiments and/or analyses following NorthStar procedures and guidelines. Ensure data is collected and documented according to good documentation practices Train other individuals for laboratory access and use of instruments.
• Independently perform tasks as needed to support product development. This may include solution preparation, equipment checks, and documentation preparation.
• Maintain and manage specific laboratory controls including equipment calibration, radiologic assays, pharmaceutical compounding, solution preparation, inventory control, chromatography reagent preparation, and quality control testing.
• Collaborate and author documents related to qualification of equipment, consumables, and processes as assigned.
• Train other team members as appropriate.
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After 3 months you will:

• Be qualified to enter controlled spaces such as laboratories
• Trained on ALARA principles and RAD safety
• Be able to perform basic laboratory related calibrations

After 6 months you will:

• Independently run QC assays related to radiopharmaceutical preparation
• Act as the lead for certain laboratory processes (e.g. inventory control, waste management, equipment calibration program)

Qualifications

CDMO Product Development Technician

Associate’s degree in a related science discipline or related medical field or completion of an accredited Nuclear Medicine Technology educational program; or equivalent combination of education and experience.

Knowledge of ALARA principles preferred.  Previous experience in a nuclear pharmacy, nuclear medicine department, laboratory setting, or cGMP environment preferred.

CDMO Product Development Technician II

Associate’s degree in a related science discipline or related medical field or completion of an accredited Nuclear Medicine Technology educational program required and minimum two (2) years of experience handling radioactive materials and operating radiation detection equipment; or equivalent combination of education and experience.

Knowledge of ALARA principles required.  Previous experience in a nuclear pharmacy, nuclear medicine department, laboratory setting, or cGMP environment preferred.

Please note the company cannot provide immigration-related sponsorship (including H-1B status, O-1 status, Optional Practical Training support, etc.) for this position.  Each successful applicant will be required to complete the Form I-9, Employment Eligibility Verification, demonstrating both identity and employment authorization, on or before the first day of employment.  Under federal law, only truthful information may be provided on the Form I-9.