Senior Microbiologist

API • Edmonton, AB

11d • Onsite

About The Position

Applied Pharmaceutical Innovation (API) is a company dedicated to advancing life-saving research by connecting academic discoveries with commercial product development. API is a rapidly growing team focused on creating collaborative opportunities to commercialize Canadian life sciences discoveries, boost R&D in Canada, and support Alberta's role in the life sciences sector. The Senior Microbiologist will be a key part of the Canadian Critical Drug Initiative (CCDI), a project with the University of Alberta aimed at establishing an integrated research, commercialization, and manufacturing cluster in the Edmonton Metropolitan Region. This involves upgrading the Biotechnology Business Development Centre (BBDC) with GMP-certified manufacturing suites and establishing the Critical Medicines Production Centre (CMPC), a large-scale manufacturing facility for small-molecule products, sterile, aseptic fill, and finishing of traditional and biologic drugs to address drug shortages.

Requirements

• Minimum Bachelor’s degree in Microbiology or related areas.
• 3+ years of experience as Microbiologist/Senior Microbiologist within a biotechnology/pharmaceutical aseptic manufacturing environment facility.
• Demonstrated experience in microbial and endotoxin testing of in-process & finished product, aseptic process simulations, environmental monitoring and testing of utilities (water, steam, etc.).
• Strong oral and written communication skills.
• Ability to handle confidential information and frequent internal and external interactions.
• Excellent attention to detail and critical thinking.
• Ability to manage time effectively and prioritize tasks in a fast-paced environment.
• Ability to meet deadlines and troubleshoot problems efficiently.
• Ability to work independently and as part of a team.
• Technically adaptable, flexible, and forward-thinking.
• Committed to continuous learning, reviewing scientific literature, and staying current with new technical and scientific information.
• Required travel between Edmonton API sites.
• Full-time on-site presence required.
• Occasional moderate physical activity, including standing, walking, lifting, and keyboarding.

Nice To Haves

• Thorough knowledge of GMP, FDA, Health Canada and EU regulations (especially sterile manufacturing) and guidance’s, combined with the ability to adopt best practices by responding quickly to a changing regulatory environment.
• Knowledge on USP<61>, USP<62>, USP <85>, USP <71>.
• Experience as Biosafety /Alternative Biosafety officer is an asset.
• Experience with handling wide range of microbiological equipment like Isolator, Vitek 2 compact, Biosafety Cabinets, Autoclave, Incubators, particle counters, air samplers and compressed gas samplers.
• Proficient in interpreting microbiological test results, including colony counts, growth characteristics.
• Extensive experience in conducting microbial endotoxin OOS investigations or Media Fill deviations and the implementation of corrective actions and preventive actions (CAPAs).

Responsibilities

• Lead and support microbiology operations for a GMP-compliant sterile pharmaceutical manufacturing facility.
• Oversee the implementation and qualification of microbiology laboratory systems, environmental monitoring programs, contamination control strategies, and microbiological testing.
• Ensure compliance with Health Canada, FDA, EU GMP, and Annex 1 requirements.
• Implement a Microbiology system for Operations, including knowledge of regulatory requirements for sterile pharmaceutical product manufacturing.
• Assist in the qualification of the new CMPC Microbiology Lab to meet GMP requirements.
• Lead qualification activities and write URS, VRA, VP, and other qualification documents for microbiology-specific instruments.
• Write procedures for environmental monitoring systems and microbiology lab operations.
• Qualify equipment and perform risk assessments for environmental monitoring.
• Assist with Media-fill strategy and cleaning procedures.
• Plan, implement, and complete assigned tasks in a timely fashion ensuring high quality.
• Provide daily in-lab mentorship to microbiologists, fostering strong techniques, aseptic practices, and best practices.
• Review microbial data, protocols, reports, and testing documentation.
• Perform comprehensive gap analysis and implement actions to meet requirements.
• Set up a contamination control strategy for the site.
• Act as Alternate Biosafety Officer and write procedures to support HPTA and DEL License.
• Perform raw materials, in-process, water, clean steam samples and sterility testing.
• Perform routine environmental monitoring for cleanrooms.
• Perform routine record review and data analysis to identify trends.
• Update management on trends and implement corrective action plans.
• Write microbiological Standard Operating Procedures, method/equipment qualification protocols, and method transfers.
• Compile and review Change controls related to the microbiological department.
• Troubleshoot technical issues and difficulties with microbiological testing methods.
• Interact with clients to maintain positive relationships and ensure their microbiological testing needs are met.
• Perform and oversee regular system qualification and calibration for microbiological testing equipment.
• Responsible for all HSE regulations in the department.
• Responsible for all Biosafety regulations in the department.

Benefits

• Comprehensive health coverage plan with 100% premium coverage.
• RRSP Matching Program (up to 1-3% of base salary).
• Professional development opportunities (training programs, workshops, conferences, certifications).
• Generous paid time off (PTO) policy (vacation days, medical/personal days, holidays).
• Green Transit Allowance.
• 20 Work From Home days (subject to eligibility and approval).

What This Job Offers

• Job Type: Full-time
• Career Level: Senior