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Manager, Microbiology
4 weeks ago
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. API is driven, compassionate, and laser focused on making a dramatic positive impact with everything it undertakes. Join API and be part of a rapidly growing team creating collaborative opportunities to commercialize Canadian life‑science discoveries, increasing commercial research and development in the country, and supporting Alberta as a key pillar in Canada’s life‑science sector. Key Responsibilities Implementation of a microbiology system for operations, including regulatory knowledge (Health Canada, FDA, EU) for testing sterile pharmaceutical products. Assist in construction and qualification of a new CMPC microbiology laboratory to meet GMP requirements. Lead qualification activities and write URS and other qualification documents for microbiology‑specific instruments (autoclaves, incubators, etc.). Set up an environmental monitoring system in the new sterile manufacturing facility (CMPC). Qualify equipment for environmental monitoring, e.g., particle counter. Assist and develop media‑fill strategy and cleaning procedures with production. Coaching, mentoring, and training microbiologists and cross‑functional team members on microbial principles in controlled clean rooms. Perform a comprehensive gap analysis and implement actions to meet Annex 1 requirements. Set up a contamination control strategy for the site. Operations Responsible for a microbiology laboratory ensuring completion of raw‑material, in‑process, water, clean steam, and final sterile product testing. Perform routine record review and data analysis to identify trends; update management and implement corrective actions when necessary. Represent the company as an SME during GMP regulatory inspections and client audits to address microbiology issues and develop solutions. Manage a team, including performance management, succession planning, and workload distribution. Write microbiological SOPs, method/equipment qualification protocols, and method transfers. Maintain proficiency in a wide range of microbiological testing methods (sterility, endotoxin, microbial identification). Interpret microbiological test results, including colony counts and growth characteristics. Investigate and resolve OOS and Mediafill deviations, implementing CAPAs. Compile and review change controls related to the microbiological department. Troubleshoot technical issues with microbiological testing methods to ensure accuracy and reliability. Interact with clients to maintain positive relationships and meet their testing needs. Oversee regular system qualification and calibration of microbiological testing equipment. Oversee environmental monitoring of clean rooms and support critical controlled areas. Maintain aseptic techniques and support training on gowning and aseptic behavior in clean rooms. HSE Responsible for all HSE regulations in the department. Qualifications Minimum master’s degree in microbiology or related area. Additional education in SixSigma principles or similar is an asset. Thorough knowledge of GMP, FDA, Health Canada, and EU regulations for sterile manufacturing. 3+ years’ experience as a Microbiology Manager leading a team in a biopharma aseptic manufacturing environment. 5+ years of progressive experience in a microbiology role in the pharmaceutical industry. Demonstrated experience in microbial and endotoxin testing, environmental monitoring, and testing of utilities. Strong technical background with previous pharmaceutical industry experience. Personal Competencies Strong oral and written communication skills; ability to handle confidential information. Excellent attention to detail and critical thinking. Effective time management and task prioritization. Physical activity: standing, walking, lifting, keyboarding. Ability to meet deadlines and troubleshoot problems efficiently. Independent and team-oriented problem solver. Technically adaptable, flexible, and forward‑thinking. Committed to continuous learning and staying current with scientific information. Proficiency in Microsoft Office applications (Word, Excel, Outlook). LIMS proficiency is an asset. Working Conditions Required travel between Edmonton API sites. This position requires on‑site presence. Exposure to chemicals and laboratory equipment. Work in laboratory and office settings. Potential relocation to CMPC once construction is complete. Additional Required Documents Applications submitted without a resume and cover letter will not be reviewed. Perks and Benefits at API Comprehensive Health Coverage – 100% premium coverage for employees and dependents. Payment in Lieu of Pension – 15% of annual base salary as an alternative to traditional pension. Professional Development Opportunities – access to training, workshops, conferences, and certifications. Collaborative and Inclusive Environment – workplace that values diversity and teamwork. Generous Paid Time Off – vacation days, medical/personal days, and holidays. Green Transit Allowance – support for walking, biking, carpooling, and public transportation. Work From Home – eligible employees may work up to 20 remote days, subject to role and manager approval. How to Apply Submit a resume and cover letter expressing interest and explaining why you 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, please contact careers@appliedpharma.ca. Our team welcomes the unique contributions of all people, celebrating diversity across lived experiences, culture, gender, race, sexual orientation, religion, and ability. Before employment, successful candidates must complete pre‑employment screening, including background reference checks, educational credential verification, and criminal reference checks. Applicants with credentials earned outside of Canada should have their qualifications evaluated by World Education Services or the International Qualifications Assessment Service (IQAS). Application Deadline: December 18, 2025 Seniority level Mid‑Senior level Employment type Full‑time Job function Research, Analyst, and Information Technology Economic Programs Referrals increase your chances of interviewing at API by 2x. #J-18808-Ljbffr
