Job 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 CANADA. Location of work This position will be located onsite downtown at UHN near University Avenue and College Street.
Overview Reporting to the Director, Quality Assurance and Quality Control, the Microbiologist will:

• Serves as the microbiology subject matter expert for the GMP manufacturing operations.
• Serves in a lead role to set up and establish the environmental monitoring of aseptic operations.
• Provides leadership, guidance, and support to Quality Assurance and Production to ensure aseptic manufacturing is executed in accordance with cGMP, ICH Guidelines and the FDA Code of Federal Regulations for aseptic drug products.

Objectives

• To 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.
• To 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).

Accountabilities

• Oversees microbiological sampling of raw materials, in-process materials and final product, as well as the equipment and conditions in which aseptic manipulations take place.
• Performs technical review of batch records to ensure quality of aseptic processes.
• Review and approve micro test results including but not limited to environmental monitoring, sterility tests, growth promotion, microbial limits tests and antimicrobial effectiveness tests.
• Responsible for review and update all microbiology related SOPs to ensure the procedures are consistent with the site practice and complaint to regulatory requirements.
• May perform validation, technology transfer and troubleshooting, and write policy procedure for quality initiatives.
• Reviews and approves environmental monitoring data and laboratory equipment and records.
• Responsible for writing environmental monitoring report for the site.
• Responsible for conducting media fill certification for production operators.
• Serves as a SME during microbiology related investigation.

Requirements

• BS/BA degree in Biology or Microbiology required
• 5 \xe2\x80\x93 7 years\' of pharmaceutical industry experience
• An excellent understanding and knowledge of microbiology and methods of testing for the presence of and identification of micro-organisms
• Experience with microbial species identification
• Experience creating and executing cleaning validation studies and protocols necessary to establish aseptic operations.
• Experience creating and executing sterility validation studies, such as media fills and bioburden study.

Competencies

• Excellent oral and written communication skills
• Demonstrated ability to function well in a collaborative team environment.
• Ability to plan, develop and execute multiple projects under tight timelines
• Operate and execute with an extreme sense of urgency
• Excellent organizational and interpersonal skills
• Demonstrated proficiency in Microsoft Office (including Outlook, Word, PowerPoint, Excel)
• Ability to collaborate with QA, CMC and regulatory colleagues to establish and justify release and stability speci\xef\xac\x81cations for starting materials, intermediates, drug substances and drug products
• Manage multiple projects, set priorities, and work in a fast-paced 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 \xe2\x80\x93 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

• Eligible for annual incentive bonus plan and stock options
• Healthcare plan (medical, dental, vision) \xe2\x80\x93 effective day 1
• Disability
• Life insurance
• RRSP matching plan

• Paid Time Off (Vacation, Personal Days, Sick Days & Public Holidays)
• $500 fitness reimbursement
• $50 cell phone reimbursement per month ($1,300 per year)

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.