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 is full time – onsite.
Key Responsibilities, include but are not limited to:
Quality Assurance:
- Provide on-site support for licensed activities at the BBDC facility, including DEL operations.
- Manage GMP documentation and support the implementation of an electronic Quality Management System (QMS).
- Develop and improve procedures and processes to meet regulatory requirements (Health Canada, US FDA, EU GMP).
- Train new and existing personnel on quality standards and practices.
- Record, review, and approve GMP documentation, including batch records and product release.
- Support product recall activities and report on key quality performance indicators.
- Assist with validation and qualification of Quality processes and equipment.
- Contribute to Annual Product Quality Reviews (APQR) and Quality Management Reviews (QMR).
Quality Compliance:
- Support internal quality audits and external inspections by regulatory agencies and customers.
- Assess compliance risks and implement mitigation measures.
- Ensure adherence to internal Quality and GMP procedures, including data integrity.
- Maintain inspection readiness and communicate concerns to Senior Leadership as needed.
Product Quality, Data Recording, and Integrity:
- Assist in resolving customer complaints and queries.
- Collaborate on continuous improvement initiatives and stay updated on quality management practices.
- Prepare quality documentation and reports, summarizing trends within the QMS.
Occupational Health and Safety:
- Ensure compliance with environmental health and safety (EHS) policies and procedures.
Qualifications - (Education, Certification, Degree, Skills, Knowledge, etc.)
Education
- Must hold a Canadian university degree or a degree recognized as equivalent by a Canadian university or Canadian accreditation body related to pharmaceutical product manufacture.
Professional Experience
- Preferably 3- 5 years of experience in GMP manufacturing, QA, QC laboratory, Compliance, or similar operational areas in pharmaceutical production with experience in manufacture of parenteral and sterile pharmaceutical products and oral pharmaceutical products.
- At least 2 years of management experience required in the manufacture and packaging of active pharmaceutical ingredients, preferred, not required.
- Training in GMPs, Management Supervisory Skills
- GMP regulatory standards applicable to Canada, and a working knowledge of external regulations and requirements, such as US 21 CFR Part 211 and EU GMP guide Part 1.
- Experience in computerization, preferred, not required.
Personal Competencies
- Strong oral and written communication; handles confidential information; frequent internal and external interactions.
- Some autonomy; follows guidelines; analyzes complex data; may make recommendations.
- Requires high concentration and critical thinking.
- Occasional moderate physical activity; includes standing, walking, lifting, and keyboarding.
- Moderate responsibility for potential errors impacting resources.
- Manages policies, procedures, and personnel; demonstrates leadership, negotiation, and organizational skills.
- May involve some budgeting responsibilities.
Working Conditions
- Required travel between Edmonton API sites.
- This position requires you to be on site.
- Office and laboratory settings.
- Possible exposure to chemicals, machinery, or equipment.
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.
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 the interest of all applicants but will only contact those selected for interviews.
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.
Job Types: Full-time, Permanent
Pay: $70,000.00-$110,000.00 per year
Benefits:
- Life insurance
- Vision care
Flexible language requirement:
Schedule:
Education:
- Bachelor's Degree (required)
Experience:
- quality assurance: 3 years (required)
- GMP pharmaceutical production: 3 years (required)
Work Location: In person
