Control Strategy Scientist

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

Control Strategy Scientist### Control Strategy ScientistCandidatar-se: Mississauga: Tempo integral: Publicado hoje: Data de término: 20 de novembro de 2026 (13 dias restantes para se candidatar): 202610-127216At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.### ### The Position**Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. As one of the world’s largest biotech companies and a global leader in in-vitro diagnostics, Roche is dedicated to driving innovative healthcare solutions that provide significant benefits to patients and healthcare providers alike. Our commitment to excellence is reflected in our culture of collaboration, where we empower our people to challenge the status quo and deliver life-changing medical breakthroughs. At Roche Canada, we foster a diverse and inclusive environment that encourages creative thinking and rewards the pursuit of excellence in our mission to shape the future of healthcare.** Network Quality Control, part of Roche Parma Technical Quality and Compliance (PTQ), supports Roche's internal QC sites and contract partners worldwide, including emerging markets, with advanced scientific and technical expertise. We are looking for a **Control Strategy Scientist (CSS)** in Mississauga to join our global team of scientists. As Control Strategy Scientist (CSS) you are the single accountable owner of the commercial analytical control strategy for one or more products of an expanding portfolio of biologics. That covers specifications, analytical methods, from in-process controls to release and shelf life, across all manufacturing and testing sites. You lead in a matrix without line authority: you work with QC sites, Analytical Development, MSAT, Regulatory and Quality, and you are a standing member of the cross-functional commercial product technical teams. Your work enables robust and efficient QC testing, faster approvals, and reliable supply of medicines to patients. **The Opportunity** * **Own the control strategy for biologics.** Keep specifications, methods and stability programs lean, state-of-the-art and harmonized across the network. Lead the global analytical subteam for one or more products and evaluate release and stability data end-to-end across sites.* **Shape new products before launch.** From late-stage development onward, influence method design, validation, specifications, reference standards and stability studies so they work in commercial QC. Drive the analytical knowledge transfer from Phase III to commercial QC.* **Manage the lifecycle.** Plan and deliver lifecycle management of control strategies. Own the overall stability budget and shelf-life extensions. Be accountable for analytical comparability protocols and reports, including statistical acceptance criteria.* **Lead the regulatory content.** Own responses to health authority information requests, author the analytical, comparability and stability sections of submissions, and support inspections and annual quality reviews.* **Solve problems across sites.** Support product-specific multi-site investigations. Own global changes and corrective and preventive actions for control system gaps. Assess temperature excursions, method monitoring results and reference standard changes.* **Drive innovation.** Bring in platform methods, new QC technologies, automation and digital solutions, and contribute to industry best-practice discussions. **Who you are** * **Education:** PhD or MSc in analytical chemistry, biochemistry or another relevant life-science discipline.* **Experience:** 7**-**10+ years in the pharmaceutical or biopharmaceutical industry, in QC, analytical development or CMC.* **Technical expertise:** Experience in analytical methods for biologics such as chromatography, electrophoresis or bioassays; method validation and transfer; experience with stability and shelf-life setting; statistical data evaluation. Experience with synthetic peptide or oligonucleotide parenterals or combination products is considered a plus.* **Regulatory knowledge:** cGMP, ICH guidelines and global CMC requirements. Experience authoring CTD Module 3 sections is an asset.* **Leadership:** You influence without authority, communicate clearly in writing and in person, and build trust with sites, partners and health authorities. You follow the science, act as one team and simplify radically.**\\*\\*Relocation not eligible for this role\\*\\***The expected salary range for this position based on the primary location of Mississauga is 136,936.00 and 179,728.50 of hiring range. Actual pay will be determined based on experience, qualifications, and other job-related factors as determined by the company.We use artificial intelligence to screen, assess or select applicants for this role.This posting is for an existing vacancy at Hoffmann-La Roche Ltd.