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.
