Biologics Control Strategy Lead

Roche; Mississauga; On-site; CAD 137,000 - 180,000; Full time

Job summary

Roche Canada in Mississauga is seeking a Control Strategy Scientist to own the analytical control strategy for biologics across a growing product portfolio. You will coordinate with QC sites, Analytical Development, MSAT, Regulatory and Quality to ensure robust testing and timely approvals.

You will shape method design, validation and stability programs from late-stage development through commercial QC, manage lifecycle and budgets, and contribute to regulatory submissions and inspections.

Qualifications

• PhD or MSc in analytical chemistry, biochemistry or life-science discipline.
• Experience in QC/analytical development or CMC in pharma/biopharma.
• Strong ability to lead cross-site teams and communicate across functions.

Responsibilities

• Own the control strategy for biologics, overseeing specifications, methods, and stability programs across the network.
• Lead the global analytical subteam and evaluate data end-to-end across sites.
• Shape method design, validation, and specifications from late-stage development to commercial QC.
• Manage lifecycle, stability budgets and shelf-life extensions.
• Lead regulatory content, respond to health authority information requests, and support inspections.
• Drive innovation with new QC technologies and data-driven approaches.

Skills

Analytical chemistry

Biochemistry knowledge

Regulatory knowledge

Leadership

Education

PhD or MSc in analytical chemistry / life sciences

Job description

Roche Canada in Mississauga is seeking a Control Strategy Scientist to own the analytical control strategy for biologics across a growing product portfolio. You will coordinate with QC sites, Analytical Development, MSAT, Regulatory and Quality to ensure robust testing and timely approvals.

You will shape method design, validation and stability programs from late-stage development through commercial QC, manage lifecycle and budgets, and contribute to regulatory submissions and inspections.