Team Lead, Manufacturing (Isolators), Toronto

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 CANADA.

Location of work

This position will be located onsite downtown at UHN near University Avenue and College Street.

Overview

Reporting to the Senior Manager in Production at the POINT Institute for Radioligand Innovation (PIRI), the Team Lead in Manufacturing will:

• Lead the production of drug products following strict cGMP guidelines and resolve all production-related quality events in a timely manner.
• Demonstrate ability to function well in a collaborative team environment.
• Safely work with radioactive materials following ALARA principles and Canadian Nuclear Safety Commission (CNSC) guidelines.
• Utilize and monitor all manufacturing-related equipment and assist with resolving technical issues, as well as maintenance of production equipment.
• Maintenance to facilitate on-time release of drug products and radioisotopes.
• Coordinate Production activities with Quality Control, Quality Assurance, and Plant
• Coordinate, schedule and plan isolator related projects with isolator manufacturing.
• Participate in technical transfer and process validation activities in collaboration with other departments, as needed.
• Be detail-oriented and meticulous with execution of tasks and documentation.

Responsibilities

• Support the technical transfer, development, and validation of production methods associated with finished dosage form (FDF) drug products and radioisotope products.
• Manual and/or automated production of aseptic radiopharmaceutical drug product and
• Radioisotopes in accordance with established manufacturing batch records.
• Monitor of the production-related equipment used to ensure proper function and report any
• Maintenance needs to plant engineering.
• Lead continuous process improvement initiatives of existing manufacturing methods via
• Lead investigation, resolution, and mitigation of deviations, non-conformances, and OOS (Out of Specification) events associated with product manufacturing at the POINT GMP facility.
• Current Good Manufacturing Practices (cGMP).

Supervise clinical production of all drug products ready for GMP manufacturing at the PIRI facility. This will include:

• Lead investigations for quality events during routine manufacturing
• With the support of Quality, ensure the production team operates in accordance with cGMPs to produce drug product within specification
• Organizing and scheduling of manufacturing activities, production technicians and manufacturing
• Aid in the setup of any new clean room procedures or validation of new clean room.
• Track and trend batch data, and ensuring manufacturing and related quality KPls are met
• Provide training and guidance to production staff
• Qualify equipment and clean room for production use.
• Effectiveness checks for GMP manufacturing activities
• Serve in a direct production role as needed
• Guidelines, policies, and SOPs
• Develop Isolator manufacturing process at the PIRI site.
• Ensure production staff consistently adhere to all health and safety, and radiation safety
• Specialists in accordance with the weekly production plan.
• Oversee implementation of corrective and preventative actions, and performing CAPA

Requirements

• First aid trained
• Bachelor of Science or diploma
• Minimum 5 years of industry experience with 1 year in a lead position
• This role works in a hospital setting and it is mandatory for all employees to complete health screens before onboarding. In the event the screen results show non-immunity, vaccines may need to be administered.
• GMP manufacturing, aseptic manufacturing, and clean room validation experience
• Radiation handling experience

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 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
• You will help establish and define an organization that will change the course of cancer therapies. and help thousands of people each year
• Most importantly, you will spend everyday working on something important

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

Benefits

• Eligible for annual incentive bonus plan and stock options
• $50 cell phone reimbursement per paycheck ($1,300 per year)
• Paid Time Off (Vacation, Personal Days, Sick Days & Public Holidays)
• Life insurance
• Healthcare plan (medical, dental, vision) – effective day 1
• $500 fitness reimbursement
• RRSP matching plan
• Disability

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.

We do not accept unsolicited inquiries or resumes from agencies.