Manager, Microbiology

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 Canada's life sciences sector.

You will be part of one of API's 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 83,000+ 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 Canada's largest and best equipped of its kind. The CMPC's focus will be on producing small-molecule product solutions, conducting sterile, aseptic fill, and finishing traditional and biologic drugs to meet drug shortages needs.

** 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 the construction and qualification of a new CMPC Microbiology-Lab to meet GMP requirements.
• Leading Qualification activities and writing URS and other qualification documents for microbiology-specific instruments such as autoclaves, incubators and other laboratory equipment common in the GMP testing micro lab.
• Set up a structure for environmental monitoring system in the new sterile manufacturing facility (CMPC)
• Qualify equipment for environmental monitoring, for example particle counter.
• Assist and develop Media-fill strategy and cleaning procedures together with production
• Set up training programs and documents for a training facility for sterile operations
• Coaching, mentoring, and training not only microbiologists but cross-functional team members in microbial principles and behavior in environmentally controlled clean rooms.
• Knowledge of the recently implemented Annex 1 and ability to perform a comprehensive gap analysis and implement actions to meet requirements.
• Set up a contamination control strategy of the site

Operations:

• Responsibility for a Microbiology Laboratory to ensure completion of raw materials, in process testing, water and clean steam samples and final sterile products.
• Performing routine record review and data analysis to identify trends. Update management on trends and implement corrective action plans when necessary.
• Representing the company as an SME during GMP regulatory inspections and client audits to address microbiology issues and develop solutions.
• Managing a team of professional(s) including performance management, succession planning (coach and develop employees) and distribution of workload.
• Writing microbiological Standard Operating Procedures, method/equipment qualification protocols and method transfers.
• Experienced in a wide range of microbiological testing methods, including, sterility testing, endotoxin testing, microbial identification.
• Proficient in interpreting microbiological test results, including colony counts, growth characteristics.
• Extensive experience in conducting microbial endotoxin OOS investigations or Mediafill 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.
• Oversee Environmental Monitoring of cleanrooms and supporting critical controlled areas in the manufacturing facility.
• Maintaining good aseptic techniques and working in compliance with regulations. Support training on gowning techniques and aseptic behaviour in cleanrooms.

HSE:

• Responsible for all HSE regulations in the department

Qualifications - (Education, Certification, Degree, Skills, Knowledge, etc.)

Education

• Minimum Master's degree in Microbiology or related areas
• Preference will be given to candidates with an advanced degree. (PhD)
• Additional education in Six Sigma principles or similar education is an asset.

Experience:

• 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.
• 3+ years of experience as a Microbiology Manager, responsible for leading a team of microbiologists within a biotechnology/pharmaceutical aseptic manufacturing environment facility.
• 5+ years of practical and progressive experience in a microbiology related role in the pharmaceutical industry for commercial drug products including experience in environmental monitoring / cleanrooms.
• 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 technical background with previous experience working in pharmaceutical industry.

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.
• Occasional moderate physical activity, including standing, walking, lifting, and keyboarding.
• 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.
• Proficiency in Microsoft Office applications (Word, Excel, Outlook) and business-related software.
• Proficiency in LIMS is considered an asset.

Working Conditions:

• This position requires on-site presence.
• Exposure to chemicals and laboratory equipment.
• Work in laboratory and office settings.
• This position can potentially be moved to our new site CMPC, once the construction is complete.

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.

Payment in Lieu of Pension: API provides an additional 15% of your annual base salary, as an alternative to traditional pension benefits.

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 everyone's 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 10 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 careers@appliedpharma.ca.

Our team, clients, and stakeholders come from a variety of backgrounds. In 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.

Application Deadline: May 6, 2025