Manufacturing Specialist, Medical Isotope

POINT Biopharma is an innovative, high-performance company focused on a hard problem: creating new cancer therapies that are more effective and have fewer side effects than traditional treatments. Our products are targeted radioligands, a technology that hold significant promise to treat cancer. Our company is growing rapidly: we just announced a phase 3 clinical trial for our novel radioligand based prostate cancer treatment, established our U.S. manufacturing center in Indianapolis, and have a pipeline of next generation oncology products in development. We are a creative and agile team accountable to a high standard: to be uniquely better. If you are searching for new and uniquely better career path, you should consider joining the POINT team.

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 Manufacturing Specialist will have functional responsibility for:

• Manual and/or automated production of radioisotopes in accordance with established manufacturing batch records under GMP conditions.
• Supporting the technical transfer, development, and validation of production methods associated with radioisotope manufacturing, fill/finish and terminal sterilization.
• Investigation, resolution, and mitigation of deviations, non-conformances, and OOS (Out of Specification) events associated with manufacturing radioisotopes.
• Monitoring of production-related equipment used to ensure proper function and reporting any maintenance needs to plant engineering.
• Continuous process improvement of existing manufacturing methods via current Good Manufacturing Practices (cGMP).
• The position is based in Indianapolis, Indiana, U.S. and directly reports to the Director of Medical Isotope Manufacturing.

Objectives

• To successfully produce radioisotopes 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 radioisotopes for input into downstream drug product production activities.
• To support technical transfer, equipment and process installation and qualification, and collaboration with other departments, as needed.
• To safely work with radioactive materials following ALARA principles and NRC guidelines.
• To successfully utilize and monitor all manufacturing-related equipment and assist with resolving technical issues, as well as maintenance of production equipment.

Accountabilities:

• Conduct and appropriately document production of radioisotopes via strict adherence to manufacturing batch records and affiliated SOPs following Good Manufacturing Practices.
• Execute batch setup procedures and line clearance procedures in accordance with master batch production records.

• Support establishment of operating equipment specifications and improve manufacturing techniques.
• 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 staff, equipment vendors, 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.
• Adhere to all applicable procedures, cGMPs, company policies and any other quality or regulatory requirements.
• Embody and promote a quality culture and "right-first-time" approach as part of all activities.
• Work well in a fast-paced team environment.
• Perform other duties as assigned

Requirements

Education and Experience:

• Associates or BS/BA degree in a technology related field of study.
• 5 or more years of relevant experience in a technical manufacturing environment or similar field of work.
• GMP manufacturing experience or experience in a highly regulated environment.
• Experience working with chemical processing or radioactive materials is considered an asset but is not a requirement.
• Position requires to work a standard first shift Monday thru Friday schedule, with occasional overtime, weekends, and off-shifts as the business requires.
• Maintain focus on a complex task for 4-6 hours at a time.

Competencies:

• Structured problem-solving skills.
• 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.

• Comfortable handling radioactivity and follow proper ALARA (As Low As Reasonably Achievable) technique.
• 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.
• Qualified ability to execute manual and/or automated radiochemical operations.
• 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 change the course of cancer therapies. and help thousands of people each year
• You will be challenged, and are expected to challenge us, as part of a results-oriented, high performance team, where everyone leaves their egos at the door and lets the best ideas win
• You will be provided the opportunity to participate in the financial value creation that occurs as POINT grows and becomes a mature pharmaceutical company
• Most importantly, you will spend everyday working on something important

If what we are saying resonates with you, please submit a resume

Benefits

• Health Care Plan (Medical, Dental & Vision) - effective day 1
• Retirement Plan (401k - up to 2% match with immediate vest)
• Income Protection Insurance - (Life AD&D, Short & Long-term disability) - 100% employer paid
• Voluntary Income Protection - Premiums paid by employee
• Paid Time Off (Vacation, Sick & Public Holidays)
• $500 fitness reimbursement per year
• $50 cell phone reimbursement per pay cycle

All applicants who are offered employment with POINT Biopharma will be subject to a background investigation. Offers of employment are contingent on the successful completion of a background investigation conducted in accordance with POINT Biopharma policy and state law.

POINT Biopharma does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.