Microbiologist Ii, Toronto Jobs

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 into the Supervisor, Sterility Assurance the Microbiologist will provide technical know-how, and support to Quality Assurance while ensuring aseptic manufacturing is executed in accordance with cGMP, ICH Guidelines and the FDA Code of Federal Regulations for aseptic drug products.
Objectives

• Ensure all drug products produced and tested under aseptic conditions are manufactured to the highest standards of Good Manufacturing Practice (GMP), ICH guidelines, and according to regulatory guidelines, laws and Standard Operating Procedures (SOPs).
• Support the successful setup, qualification, training, and validation of the facility and personnel necessary to ensure product sterility assurance per regulatory standards.
• Ensure all sterile drug products produced at the manufacturing facility meet the defined sterility and endotoxin specifications and in accordance with the established Quality Management System.

Accountabilities

• Perform microbial identification.
• Process, inspect and interpret biological indicators and microbiological cultures.
• Perform microbiological testing of raw materials, in-process materials and final product.
• Prepare and review documentation for protocols, reports and test results.
• Perform validation, technology transfer and troubleshooting of microbial test methods.
• Support continuous improvement initiatives within microbiology and sterility assurance.
• Write and revise standard operating procedures.
• Support validation of sanitization and sterilization processes, including vaporized hydrogen peroxide and terminal sterilization by autoclave.
• Review and approve environmental monitoring data and laboratory equipment and records.
• Support the daily operations of a GMP microbiology laboratory.
• Perform environmental monitoring within controlled environments, including ISO7 and ISO8 cleanrooms.
• Support the evaluation and maintenance of equipment and conditions in which aseptic manipulations take place.
• Perform routine microbiological test methods according to compendial USP methods, including sterility testing, growth promotion testing, and microbial limits testing.

Requirements

• Experience with microbial species identification
• 3-5 years of pharmaceutical laboratory experience in a GMP environment
• An excellent understanding and knowledge of microbiology and methods of testing for the presence of and identification of micro-organisms
• Experience creating and executing test microbial method validations (sterility testing, bioburden testing, etc.)
• Capable of lifting up to 40lbs on an occasional basis.
• Ability to properly don clean room garments on a frequent basis.
• 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.
• Prolonged standing (>3hr) may be required during environmental monitoring.
• An excellent understanding in proper aseptic technique while performing microbial testing/sampling as well as during drug product manufacturing activities.
• Experience performing environmental monitoring in ISO controlled environments
• BS/BA degree in Biology, Microbiology, or Life Sciences

Competencies

• Ability to plan, develop and execute multiple projects under tight timelines
• Demonstrated ability to function well in a collaborative team environment
• Demonstrated proficiency in Microsoft Office (including Outlook, Word, PowerPoint, Excel)
• Excellent oral and written communication skills
• Operate and execute with an extreme sense of urgency
• Manage multiple projects, set priorities, and work in a fast-paced environment
• Excellent organizational and interpersonal skills

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
• Most importantly, you will spend everyday working on something important
• You will be provided the opportunity to participate in the financial value creation that occurs as POINT grows and becomes a mature pharmaceutical company

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

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

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.