Production Technician

POINT Biopharma Global Inc. is a globally focused radiopharmaceutical company building a platform for the clinical development and commercialization of radioligands that fight cancer. POINT aims to transform precision oncology by combining a portfolio of targeted radioligand assets, a seasoned management team, an industry-leading pipeline, in-house manufacturing capabilities, and secured supply for medical isotopes including actinium-225 and lutetium-177. POINT’s active clinical trials include FRONTIER, a phase 1 trial for PNT2004, a pan-cancer program targeting fibroblast activation protein-α (FAP-α), and SPLASH, the phase 3 trial for PNT2002 for people with metastatic castration resistant prostate cancer (mCRPC) after second-line hormonal treatment.

TO BE CONSIDERED, APPLICANTS MUST BE LEGALLY ENTITLED TO WORK IN THE USA.

Location: Indianapolis, IN. Completed in Sept 2021, POINT's Indianapolis site is one of the largest state-of-the-art radiopharmaceutical manufacturing facilities in the world - almost as large as one and a half football fields.

Overview

The Production Technician will have functional responsibility for:

• Manual and/or automated production of aseptic radiopharmaceutical drug product and radioisotopes.
• Adhering to standard operating procedures and current Good Manufacturing Practices (cGMP) to ensure quality of product.
• Monitoring of production-related equipment used to ensure proper function and report any maintenance needs to plant engineering.
• The position is based in Indianapolis, Indiana, U.S. and directly reports to the Lead Manufacturing.
• This position will work 4 ten-hour days. Manufacturing will be based on a 7/24 operation. Shift assignment will be based on both the candidate’s preference and Manufacturing needs.

Objectives

• To successfully produce radioisotopes and drug products following strict cGMP guidelines and resolve all production-related quality events in a timely manner.
• To coordinate Production activities with Quality Control, Quality Assurance, and Plant Maintenance to facilitate on-time release of drug product and radioisotopes.
• To safely work with radioactive materials following ALARA principles and NRC guidelines.
• To successfully utilize and monitor all manufacturing-related equipment.
• To successfully pass training criteria and consistently execute per procedures.

Accountabilities:

• Execute batch setup procedures, operations, and line clearance procedures in accordance with master batch production records utilizing good documentation practices.
• Safely handle and participate in the transfer of radioactive materials throughout the facility.
• Use all manufacturing equipment per its intended purpose. Understand and monitor the function and performance of all manufacturing equipment.
• Collaborate with maintenance technicians, equipment manufacturers, and quality assurance to ensure that all production equipment is in good working order and is validated for use.
• Provide verbal and written reports to supervisors in a clear and concise manner.
• Work well in a fast-paced team environment.
• Perform other duties as assigned.

Requirements

Education and Experience:

• High school diploma or GD equivalent required.
• Associates or BS/BA degree in a science related field of study is preferred.
• A degree in a science discipline or 2 years of relevant experience in a manufacturing environment.
• Having either aseptic or GMP manufacturing experience is an asset.

Competencies:

• Ability to maintain focus on a complex task for 4-6 hours at a time.
• Full range of motion and ability to use both hands. High degree of manual dexterity. Regular lifting of 10 lb weights, occasional lifting of up to 50 lbs.
• Remain focused and composed in a fast-paced environment.
• Maintain clear, consistent, and constant verbal communication with one or more team members during performance of duties.
• Aptitude to learn new techniques, applications, or processes used in radiopharmaceutical manufacturing activities.
• Good oral and written communication skills.
• Detail-oriented and meticulous with execution of tasks and documentation.
• Demonstrated ability to function well in a collaborative team environment.

Why joining POINT today will be the right career move for you:

There is no shortage of demand for smart, qualified and hardworking people like yourself – and we strongly believe POINT is the right career move for you. Here is why:

• You will help establish and define an organization that will cha