Manufacturing Technology Lead

Manufacturing Technology Lead

Join our dynamic team at Jubilant Radiopharma as Manufacturing Technology Lead! We are seeking a driven individual who thrives in a fast-paced environment and is passionate about ensuring the highest standards of quality and compliance in our operations.

Why Jubilant Radiopharma?

At Jubilant Radiopharma, we are dedicated to making a meaningful impact in the lives of patients by delivering high-quality radiopharmaceuticals. As a leader in the industry, we offer exciting opportunities for professional growth and development, along with a collaborative work environment where your contributions are valued and recognized.

Role Overview

As a Manufacturing Technology Lead, you will lead strategic initiatives: new product introductions (radioactive and nonradioactive), technology integration, and process optimization from development through validation and across the lifecycle. You will also serve as a process & product specialist.

Key Responsibilities: *Technical expertise & lifecycle management*

• Maintain process knowledge and control strategy (CPP/CQA, QbD); manage deviations, CAPAs, Change Controls; lead continuous improvement (yield, robustness, standardization).
• Ensure accuracy of registered process details and data integrity.
• *Continued Process Verification (CPV)*
• Define and execute CPV plans: statistical trending of CPP/CQAs (SPC, capability), early signal detection, and preventive/corrective actions to safeguard lot release and supply continuity.
• *Process Performance Qualification (PPQ) & validation*
• Contribute to PPQ strategy, protocols/reports, sampling plans, and statistical justification aligned with process design and regulatory expectations.
• *Technology transfer (site/CMO)*
• Lead facility fit and risk assessments; build transfer packages (process description, batch records, materials/equipment); coordinate engineering runs and person in plant support at startup.
• *Project management & operational excellence*
• Plan and execute installation/qualification/commissioning of new equipment/utilities with key functions.
• *Deploy GEP, Lean, and risk assessments (FMEA).*
• Facilitate team cadence, track actions/deliverables, and secure milestones and campaign readiness.
• *Health & Safety*
• Ensure contractor compliance with radiation safety and occupational H&S rules.

Qualifications

• Bachelor’s in engineering (Chemistry, Biochemistry or related) or Science ; Master’s would be ideal

5 years in pharma/biopharma;* 3 years in MSAT/industrialization roles.

• Strong knowledge of cGMP, CPV/PPQ,
• Proficiency in Microsoft 365, Visio, Smartsheet; experience with JMP, R, Python.
• Bilingual English/French; Supports technology transfer between the clinical or R&D phase and production, including production outside Quebec.
• Medical device familiarity is an asset.

Core Competencies

• Strong technical judgment; advanced problem solving (statistics, RCA).
• Rigorous, detail oriented, results driven; data integrity mindset.
• Leadership and stakeholder communication (Quality, R&D, Supply, Manufacturing, Regulatory).
• Autonomous, resourceful, deadline driven; innovation minded.

Career Development & Culture

• Continuous learning (validation/qualification, analytics, digital), internal mobility, innovation projects.
• Culture centered on safety, quality, inclusion, and collaboration, with tangible patient impact.