Director, Validation

API • Edmonton, AB

1d • Onsite

About The Position

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.

Requirements

• Minimum Master’s degree in Chemistry, Pharmacy, Chemical Engineering or similar.
• Thorough knowledge of GMP, FDA, Health Canada and EU regulations (API-production and sterile manufacturing) and guidance’s, combined with the ability to adopt best practices by responding quickly to a changing regulatory environment.
• 10+ years experience in pharmaceutical validation, process qualification, and Product implementation within a GMP-regulated manufacturing environment.
• Deep knowledge in calculation cleaning limits based on the MAC principle under usage of HBEL is a must. Understanding PDE, ADE and NOAEL dependencies.
• Demonstrated experience in sterile manufacturing, including formulation filling, visual inspection and packaging.
• Deep knowledge in pharmaceutical drug development, chemical synthesis and pharmaceutical technology.
• Experience preparing for and supporting regulatory inspections with global health authorities.
• Strong oral and written communication skills, with the ability to handle confidential information and frequent internal and external interactions.
• Strong project leadership and people management experience.
• Ability to manage time effectively and prioritize tasks in a fast-paced environment.
• Occasional moderate physical activity, including laboratory work in a chemical synthesis laboratory standing, walking, lifting, and keyboarding.
• Ability to meet deadlines and troubleshoot problems efficiently.
• Technically adaptable, flexible, and forward-thinking.
• Proficiency in Microsoft Office applications (Word, Excel, Outlook) and business-related software.

Nice To Haves

• Additional education in SixSigma principles or similar education is an asset.

Responsibilities

• Set up validation strategies.
• Set up cleaning validation strategies and processes.
• Define cleaning limits for API-reaction vessels and formulation tanks with help of using the MACO-principle, HBEL limits.
• Write and review validation protocols and reports in collaboration with the team.
• Write and review cleaning validation protocols and reports.
• Assist with and review media fill plans and reports.
• Ensure regulatory compliance and operational efficiency throughout process development and manufacturing scale-up.
• Prepare for and support regulatory inspections with global health authorities.
• Defend validation and technology transfer strategies during inspections.
• Responsible for commercial implementation of customer products or products transferred from Translational Services Division.
• Responsible for Product areas: Chemical-API-production (small to mid scale) and sterile liquid injectable products from Formulation, Filling, Terminal sterilization, Inspection, Packaging.
• Work closely with the Translational Services Division and R&D-departments to transfer new or generic products.
• Assist the Project Manager in project-planning and material and personnel resource capacity in Technical Operations.
• Support analytical method transfers and process implementation activities.
• Optimize manufacturing parameters to improve efficiency, robustness, and scalability.
• Define Critical process parameter for the production processes.
• Set up engineering batches and improvements until commercialisation.
• Perform process gap analysis, fit-to-plant assessments, equipment/process characterization, and scale-up activities.
• Conduct FMEA-based risk assessments to support robust manufacturing processes.
• Implement SOPs, and tools to support repeatable and efficient product implementation projects.
• Lead technical investigations and problem-solving activities supporting commercial manufacturing operations.
• Collaborate closely with the Translational Services Division, Engineering, Operations, and Commercialization teams to identify suitable equipment vendors and process flows.
• Support layout design, throughput optimization, safety standards, and facility fit considerations.
• Work with Procurement team together for implementation of Drug Substance and Drug Product material supply strategies, including vendor and project management.
• Author and review technical documentation related to manufacturing activities, including: Development protocols and reports, Manufacturing batch records, SOPs, Change controls, Deviations, Regulatory submissions, Product impact assessments.
• Draft and review production batch records in collaboration with Production teams.
• Interface with Production, Quality Control, and Compliance functions for: In-process support, Analytical method transfers, Raw material release, Product release, Stability programs.
• Ensure the HSE- standards in the development laboratory.
• Evaluation of potential hazards and potential safety risks for new products and processes.

Benefits

• 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 1–3% 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 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 20 Work from Home days, this is subject to job function, company needs, and manager approval.

What This Job Offers

• Job Type: Full-time
• Career Level: Director