Manager, MSAT (Manufacturing Science and Technology)

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 Canadas life sciences sector.

You will be part of one of APIs 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 83000 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 Canadas largest and best-equipped of its kind. The CMPCs 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:

Process Development & Scale-Up

• Lead development and validation activities for bench-top to pilot and commercial scale processes (API and sterile production).
• Optimize manufacturing parameters and define process implementation strategies with Technical Operations.

Standardization & Documentation

• Design and implement scale-up templates SOPs and tools for consistent and efficient operations.
• Author and review technical documentation including protocols reports batch records change controls deviations and regulatory submissions.

Risk & Gap Analysis

• Perform process gap analysis fit-to-plant assessments equipment characterization and FMEA-based risk evaluations.

Validation & Compliance

• Write and review validation and cleaning validation protocols and reports.
• Assist with Mediafill plans and reports ensuring regulatory compliance across all phases.

Cross-Functional Collaboration

• Work closely with Engineering Operations and Commercialization teams to identify equipment vendors optimize layouts and ensure safety standards.
• Interface with Production Quality Control and compliance functions for method transfers and product release.

Cost & Resource Management

• Act as first contact for manufacturing cost evaluations for API and sterile products.
• Manage team activities including planning resourcing training and performance management.

Technical Leadership & Problem Solving

• Serve as primary process development leader for smooth technology transfers.
• Lead technical investigations and troubleshooting in support of commercial manufacturing.

Supply Chain & Vendor Management

• Oversee material supply strategies for Drug Substance and Drug Product managing vendors and project plans.

Regulatory & Quality Assurance

• Prepare for and support regulatory inspections defending validation and tech transfer strategies.
• Promote a GMP-driven culture through coaching and continuous improvement initiatives.

Performance & Continuous Improvement

• Maintain and improve key performance indicators aligned with department and product supply goals.

HSE:

• Ensure the HSE- standards in the development laboratory
• Evaluation of potential hazards and potential safety risks for new products and processes

Qualifications - (Education Certification Degree Skills Knowledge etc.)

Education

• Masters degree in Chemistry Pharmacy Chemical Engineering or similar field
• Preference will be given to candidates with an advanced degree (PhD).
• Certification in SixSigma principles or PMP is an asset.

Experience:

• 5 years of experience in pharmaceutical validation process qualification and product implementation within a GMP-regulated environment.
• Thorough knowledge of GMP FDA Health Canada and EU regulations for API production and sterile manufacturing.
• Demonstrated experience in sterile manufacturing including formulation filling visual inspection and packaging.
• Strong background in pharmaceutical drug development chemical synthesis and pharmaceutical technology.
• Experience preparing for and supporting regulatory inspections with global health authorities.
• Proficiency in Microsoft Office applications (Word Excel Outlook) and business-related software.

Personal Competencies

• 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.
• Ability to meet deadlines and troubleshoot problems efficiently.
• Technically adaptable flexible and forward-thinking.

Working Conditions:

• This position requires on-site presence.
• Required travel between Edmonton API sites
• Occasional moderate physical activity including laboratory work in a chemical synthesis laboratory standing walking lifting and keyboarding.

Additional Required Documents to Support Application

• Applications submitted without a resume AND cover letter will not be reviewed.
• Attach certificates if applicable.

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 everyones 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.

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 .

Our team clients and stakeholders come from a variety of 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: December 22 2025

Required Experience:

Manager