Production Tech I, Toronto - POINT Biopharma

POINT Biopharma

Verified Company

Toronto, Canada

3 weeks ago

Posted by:

Sophia Lee

beBee Recruiter

Description

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 of work

The position will be working at a downtown lab location near University Avenue and College Street.

Overview
Reporting to the Manager of Manufacturing, the Production Technician will have responsibility for:

Aseptic production of radiopharmaceutical drug product and radioisotopes in accordance with established manufacturing batch records.
Support the technical transfer, development, and validation of production methods associated with finished dosage form (FDF) drug products and radioisotope products.
Investigate, resolve, and mitigate deviations, nonconformances, and OOS (Out of Specification) events associated with product manufacturing at the POINT GMP facility.
Monitor productionrelated equipment to ensure proper function and compliance with the established calibration / PM equipment schedule.
Continuous process improvement of existing manufacturing methods via Current Good Manufacturing Practices (cGMP).

Accountabilities

Produce radioisotopes and drug products following cGMP guidelines and resolve all productionrelated quality events in a timely manner.
Coordinate production activities with Quality Control, Quality Assurance, and Plant Maintenance to facilitate ontime release of drug product and radioisotopes.
Participate in technical transfer and process validation activities in collaboration with other departments.
Safely work with radioactive materials following ALARA principles and NRC guidelines.
Utilize and monitor all manufacturingrelated equipment.
Conduct and appropriately document aseptic production of radiopharmaceutical drug product and radioisotopes via strict adherence to manufacturing batch records and affiliated SOPs.
Safely handle and participate in the transfer of radioactive materials throughout the facility.
Monitor manufacturing equipment to ensure performance and safety standards are met.
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.
Preparation of packages for distribution as per the regulations for the Transportation of Dangerous Goods (TDG), Packaging and Transport of Nuclear Substances (PTNS), as well as International Air Transport Association (IATA)
Provide verbal and written reports to supervisors in a clear and concise manner.
Maintain accurate and complete lab data notebooks as per cGLP and/or cGMP, as appropriate.
Adhere to all applicable procedures, cGLP, cGMPs, company policies and any other quality or regulatory requirements.
Embody and promote a quality culture and due diligence approach as part of all activities.
Work well in a fastpaced team environment.
Perform other duties as assigned.

Requirements:

BS/BA degree in a science related field of study is preferred. Other degrees and certifications will be considered with a combination of relevant work experience.
3 to 5 years of relevant experience in a manufacturing environment or similar field of work.
Aseptic and/or cGMP manufacturing experience is preferred.
Experience working with radiopharmaceuticals will be considered an asset but is not a requirement.
Shift requirements of this role will be a twoweek rotation Mon to Fri, on the following rotation 10 pm to 6 am, 4 am12pm and 9am5pm. This could include some weekend work as well.
Full range of motion and ability to use both hands mandated by machinery. High degree of manual dexterity. Regular lifting of 10 lb weights, occasional lifting of up to 50 lbs.
Ability to maintain focus on a complex task for 46 hours at a time

Competencies

Ability to maintain focus on a complex task for 46 hours at a time
Adaptable to work in a fastpaced and evolving environment
Maintain clear, consistent, and constant verbal communication with one or more team members during performance of duties
Comfortable handling radioactivity and follow proper ALARA (As Low As Reasonably Achievable) technique
Full range of motion and ability to use both hands mandated by machinery. High degree of manual dexterity. Regular lifting of 1