Senior Microbiologist

Applied Pharmaceutical Innovation (API) brings life-saving research to the real world by helping life science innovators bridge the gap between academic research and commercial product development. We are driven compassionate and laser focused on making a dramatic positive impact with everything we undertake.

When you join API you are part of a rapidly growing team that is creating collaborative opportunities to commercialize Canadian life sciences discoveries increasing the amount of commercial research and development in the country and supporting Alberta as a key pillar in Canadas life sciences sector.

You will be part of one of APIs most important projects the Canadian Critical Drug Initiative (CCDI). The CCDI is a project led by API in partnership with the University of Alberta. It aims to establish an integrated research commercialization and manufacturing cluster in the Edmonton Metropolitan Region.

One aspect of the project involves upgrading the Biotechnology Business Development Centre (BBDC) in the Edmonton Research Park. The upgrade will include GMP-certified manufacturing suites for API-manufacturing chemical-physical testing and Health Canada-approved warehousing capacity.

The second part of the project is the Critical Medicines Production Centre (CMPC) which will be a new 83000 square-foot manufacturing facility located on a 7-acre plot of land in the center of the Edmonton Research Park. This facility is set to be Canadas largest and best equipped of its kind. The CMPCs focus will be on producing small-molecule product solutions conducting sterile aseptic fill and finishing traditional and biologic drugs to meet drug shortages needs.

The Senior Microbiologist is responsible for leading and supporting microbiology operations for a GMP-compliant sterile pharmaceutical manufacturing facility. This role oversees the implementation and qualification of microbiology laboratory systems environmental monitoring programs contamination control strategies and microbiological testing to ensure compliance with Health Canada FDA EU GMP and Annex 1 requirements.

** Please note this position requires full-time on-site presence.

Key Responsibilities include but are not limited to:

Implementation of a Microbiology system for Operations:

• Knowledge of regulatory requirements (Health Canada FDA and EU) for microbiology testing related to the manufacturing of sterile pharmaceutical products.
• Assist in qualification of a new CMPC Microbiology Lab to meet GMP requirements.
• Leading Qualification activities and writing URS VRA VP and other qualification documents for microbiology-specific instruments such as autoclaves incubators Vitek and other laboratory equipment common in the GMP testing micro lab.
• Write procedures for environmental monitoring systems and microbiology lab operations for new sterile manufacturing facility (CMPC)
• Qualify equipment and perform risk assessments for environmental monitoring.
• Assist Media-fill strategy and cleaning procedures together with production.
• Plan implement and successfully complete assigned tasks in a timely fashion ensuring consistent high quality.
• Providing daily in-lab mentorship to the microbiologists fostering strong techniques aseptic practices and microbiological best practices.
• Reviewing microbial data protocols reports and testing documentation.
• Extensive Knowledge of EMPQ and EU Annex 1 guidelines.
• Ability to 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.

Operations:

• Perform raw materials in process water clean steam samples and sterility testing.
• Perform routine environmental monitoring for the cleanrooms.
• Perform routine record review and data analysis to identify trends.
• Update management on trends and implement corrective action plans when necessary.
• Writing microbiological Standard Operating Procedures method/equipment qualification protocols and method transfers.
• Experienced 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).
• Compile and review Change controls related to the microbiological department
• Troubleshoot technical issues and difficulties with microbiological testing methods ensuring accuracy and reliability.
• 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 to maintain accuracy and compliance with regulatory standards.

HSE:

• Responsible for all HSE regulations in the department.
• Responsible for all Biosafety regulations in the department.

Qualifications - (Education Certification Degree Skills Knowledge etc.)

Education

• Minimum Bachelors degree in Microbiology or related areas.

Experience:

• 3 years of experience as Microbiologist/Senior Microbiologist within a biotechnology/pharmaceutical aseptic manufacturing environment facility is required.
• Demonstrated experience in microbial and endotoxin testing of in-process & finished product aseptic process simulations environmental monitoring and testing of utilities (water steam etc.).
• Thorough knowledge of GMP FDA Health Canada and EU regulations (especially sterile manufacturing) and guidances combined with the ability to adopt best practices by responding quickly to a changing regulatory environment is preferred.
• Knowledge on USP<61> USP<62> USP <85> USP <71> is preferred.
• Experience as Biosafety /Alternative Biosafety officer is an asset.

Personal Competencies

• Strong oral and written communication skills with the 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 to achieve organizational objectives.
• Technically adaptable flexible and forward-thinking.
• Committed to continuous learning reviewing scientific literature and staying current with new technical and scientific information.

Working Conditions:

• Required travel between Edmonton API sites.
• This position requires you to be on site.
• Occasional moderate physical activity including standing walking lifting and keyboarding.

Additional Required Documents to Support Application

• Applications submitted without a resume AND cover letter will not be reviewed.

Perks and Benefits at API

Comprehensive Health Coverage: At API we prioritize the well-being of our employees. We offer a comprehensive health coverage plan. Our premiums are 100% covered ensuring that you and your dependents receive the necessary healthcare support.

Retirement Savings: API offers a RRSP Matching Program. Employees may be eligible to participate with API matching of contributions up to 13% of base salary in accordance with program terms.

Professional Development Opportunities: We foster a culture of continuous learning and growth. API provides access to various professional development opportunities including training programs workshops conferences and certifications. We encourage employees to enhance their skills broaden their knowledge and stay updated with the latest advancements in the life sciences industry.

Collaborative and Inclusive Environment: At API we believe in the power of collaboration and diversity. We foster an inclusive work environment that values and respects individuals from all backgrounds. We promote teamwork open communication and a supportive atmosphere where everyones contributions are valued.

Generous Paid Time Off: We understand the importance of taking time off to recharge and maintain a healthy work-life balance. API offers a generous paid time off (PTO) policy that includes vacation days medical/personal days and holidays. We encourage our employees to prioritize their well-being and enjoy quality time away from work.

Green Transit Allowance: Employees based out of an office are eligible to enroll in our green transit program which promotes the use of environmentally friendly modes of transportation. By participating in the program you commit to making green transit your primary mode of transportation for at least 75% of your commute to and from work. Green transit includes walking biking carpooling and public transportation.

Work From Home: Eligible employees are entitled to 20 Work from Home days this is subject to job function company needs and manager approval.

How to Apply

Interested applicants must submit a resume and cover letter expressing their interest in the position and why they believe they are a strong candidate.

We appreciate all applicants interest and will only contact those selected for interviews.

If you have any questions about the application process or require accommodations during the hiring process please contact .

Our team clients and stakeholders come from a variety of recruiting for our team we welcome the unique contributions that all people bring to the workplace in terms of varied lived experiences education culture gender race sexual orientation religious or ethnic background neurodiversity and cognitive and physical ability.

Before employment successful candidates will be required to meet the requirements of a pre-employment screening which includes background reference checks educational credential verification and criminal reference checks.

This position will remain open until filled.

Required Experience:

Senior IC