Senior Technologist, Production

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.

Manufacturing Activities Key Responsibilities, include but are not limited to:

• Possess strong knowledge of API production and finished drug product forms, particularly in sterile manufacturing.
• Responsible for commercial manufacturing
• Operates on the manufacturing floor in accordance with cGMP’s and standard operating procedures.
• Prepares equipment for manufacturing operations and monitors equipment to ensure process specifications are met.
• Uses and maintains bench top equipment in accordance with relevant procedures.
• Effectively demonstrates understanding of cGMP & applies to specific responsibilities.
• Follows accurate oral & written procedures when operating production equipment & performing processing steps.
• Maintains orderliness of process area. Cleaning of aseptic manufacturing areas/suites as per established procedure.
• Practices safe work habits and adheres to API’s safety procedures and guidelines.
• Identifies areas for process improvements / procedure revisions as applicable.
• Utilizes manufacturing knowledge to improve process operations and affect positive change
• Escalates issues related to product and safety to senior staff and management.
• Performs all other job-related duties as assigned.

Documentation And Compliance Activities

• Lead and assist to generate GMP production related documentation such as Standard Operation Procedures, Work Instructions, Production Batch Records, label templates Change Controls, Deviations, CAPAs, etc.
• Assists in the review and creation of documents by providing input to technical composition of documents
• Prepare training material and train team members, colleagues, etc.

Qualification Activities

• Supports Validation, Engineering and Facilities personnel in installation, qualification and routine maintenance of manufacturing equipment, utilities and facilities.
• Supports the technical transfer of new products into the manufacturing area.
• Supports QA during audits and regulatory inspections.

Occupational Health And Safety

• Ensure compliance with environmental health and safety (EHS) policies and procedures.

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

• Bachelor or Master degree related to pharmaceutical product manufacturing.

Experience

• 1-3 years of experience in pharmaceutical production, preferably in API and Sterile formulation, filling, inspection or packaging.
• Experience in GMP environment required.
• Mathematical ability, e.g., decimals, addition, subtraction, problem-solving.
• Experience in Excel and Word, including creating documents to be used on the manufacturing floor.

Personal Competencies

• Strong oral and written communication.
• Good interpersonal skills with the ability to interact with people at all levels with sensitivity and tact.
• Ability to take direction.
• Enthusiastic and willing to learn.

Working Conditions

• Required travel between Edmonton API sites.
• Job requires shift work including weekends, occasional extended shifts, and possible short notice schedule shifts.
• Occasional use of a half face, and full-face respirator.
• Lifting/pushing/pulling up to 25kg, and direct contact with alcohol/chlorine based disinfectant agents
• Possible exposure to chemicals, machinery, or equipment.
• Gown qualified for sterile operations in clean rooms.
• Respirator fit testing, as required under Alberta OHS Code, Part 18 (every 2 years or upon significant changes).
• Pulmonary function testing to assess fitness for respirator use.
• Completion of vision testing examination (and periodic re-examinations), including color vision assessment, to support tasks requiring visual accuracy and vile inspections.
• Ongoing compliance with all applicable Alberta OHS health surveillance requirements.

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