Posted yesterday
Control Strategy Scientist
@ Roche
Mississauga, Ontario
Overview
Roche is hiring a Control Strategy Scientist in Mississauga to own the commercial analytical control strategy for one or more biologics products across all manufacturing and testing sites. The role covers specifications, methods, stability and shelf life, and regulatory content. The posting states a salary range of 136,936 to 179,728.50 and notes relocation is not eligible.
Responsibilities:
- Gérer la stratégie de contrôle analytique des produits biologiques
- Assurer le cycle de vie des stratégies de contrôle et la stabilité
- Diriger les soumissions réglementaires et les réponses aux autorités
- Résoudre les problèmes multi-sites et les actions correctives
- Introduire des méthodes et technologies innovantes
Requirements summary:
- Doctorat ou maîtrise en chimie analytique ou sciences de la vie
- 7 à 10 ans d'expérience en pharmaceutique ou biopharmaceutique
- Expertise en méthodes analytiques pour biologiques
- Connaissance des normes cGMP et ICH
- Expérience en rédaction de sections CTD Module 3 (atout)
Tools & skills
Source and dates
Employer career site / ATS feed · phenom
- Employer posting date
- 2026-11-05
- First seen by our source
- 2026-11-07
- Source record updated
- 2026-11-07
These dates describe the source record, not a live verification that the employer is still hiring. Check the original posting.
Job details
| Seniority | Senior |
| Department | Quality assurance |
| Experience | 7+ years |
| Hours per week | 40 (estimated) |
| Work setting | Laboratory, Office |
| Position | Mostly sitting |
| Physical demands | physical low · computer high |
| Languages | English, French |
| Education | Doctorate (preferred), Master’s degree (required) |
| Fields of study | Analytical chemistry, Biochemistry, Life sciences |
Summary and details written by AI from the posting; the employer’s posting is the authority.
Roche
Saved company profile
Historical company information from a saved The Jobs API profile (LinkedIn/Crunchbase fields). It is not live-verified; figures may have changed. Missing values remain unknown.
Full company description
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry ten years in a row by the Dow Jones Sustainability Indices (DJSI). For more information, please visit https://careers.roche.com Read our community guidelines here: https://www.roche.com/some-guidelines.htm #Roche #Biotechnology #Pharmaceuticals #Diagnostics #Healthcare #PersonalisedHealthcare #GreatPlaceToWork #Innovation
- LinkedIn followers
- 4,388,965
- People associated on LinkedIn
- 105,566
- Reported office locations
- Grenzacherstrasse, Switzerland 🇨🇭 , 4070, CH
- 4414 Lake Boone Trail, Raleigh, NC 27607, US
- 7070 Mississauga Rd, Mississauga, ON L5N 5M8, CA
- Calle Dionisio Derteano 144, San Isidro, Lima 15047, PE
- 333 Buckhead Ave NE, Atlanta, GA 30305, US
- 9115 Hague Rd, Indianapolis, IN 46256, US
- Avinguda de la Generalitat, Sant Cugat del Valles, Catalonia 08174, ES
- 271 Victoria Rd, Cape Town, Western Cape 7925, ZA
- Doctor Luis Bonavita 1266, Montevideo, 11300, UY
- 201 Boulevard Armand-Frappier, Laval, QC H7V 4A2, CA
- Forrenstrasse 2, Risch, ZG 6343, CH
- 4300 Hacienda Dr, Pleasanton, CA 94588, US
- Falcon Way, Welwyn Garden City, England AL7 1TW, GB
- Calle de la Ribera del Loira, 50, Madrid, Community of Madrid 28042, ES
- Grenzacherstrasse 124, Basel, BS 4058, CH
- 430 E 29th St, New York, NY 10016, US
- 24 Fricker Rd, Sandton, Gauteng 2196, ZA
- Cerrada Molino Bezares, Miguel Hidalgo, CDMX 11910, MX
- Sandhofer Strasse 116, Mannheim, BW 68305, DE
- ulica Domaniewska 39B, Warsaw, MA 02-672, PL
- 44. Sokak, Istanbul, Istanbul 34794, TR
- Allee de la Piat, Meylan, Auvergne-Rhone-Alpes 38240, FR
- 671-75 Ganeshkhind Road, Pune, Maharashtra 411005, IN
- No. 1100 Longdong Avenue, Shanghai, CN
- Business categories
- Finance
- Health Care
- Apps
- Oncology
- Genetics
- Medical
- Personal Health
- Manufacturing
- Health Diagnostics
- Biopharma
- Medical Device
- Biotechnology
- Industrial
- Life Science
- Venture Capital
- Precision Medicine
- Pharmaceutical
- Therapeutics
- Other recorded names
- Roche
- Specialties
- biotechnology
- innovation
- personalized healthcare
- great place to work
- diagnostics
- pharmaceuticals
- research
- healthcare
- personalised healthcare
- diabetes care
- genomics
- healthcare technology
- big data
- and Science
- Profile identifies a recruitment agency
- No
- Reported total investment
- 7,790,500,000
Currency and observation date were not supplied; this is not a current valuation or a funding round.
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible. Roche is the world’s largest biotech company, with truly differentiated medicines…
| Field | Value |
|---|---|
| Industry | Biotechnology Research |
| Company size | 10,001+ employees |
| Headquarters | Switzerland 🇨🇭 |
| Organization type | Public Company |
| Specialties | biotechnologyinnovationpersonalized healthcaregreat place to workdiagnosticspharmaceuticalsresearchhealthcarepersonalised healthcarediabetes care |
| Open jobs on Jobsy | 19 |
| View page |
Chez Roche, vous pouvez être vous-même et être apprécié pour les qualités uniques que vous apportez. Notre culture encourage l'expression personnelle, le dialogue ouvert et les connexions authentiques, où vous êtes valorisé, accepté et respecté pour ce que vous êtes, vous permettant de prospérer tant personnellement que professionnellement. Voici comment nous visons à prévenir, arrêter et guérir les maladies et à garantir à chacun l'accès aux soins de santé aujourd'hui et pour les générations à venir. Rejoignez Roche, où chaque voix compte.
La 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.Nous utilisons l’intelligence artificielle pour filtrer, évaluer ou sélectionner les candidatures pour ce poste.
Cet affichage est pour un poste vacant existant chez Hoffmann-La Roche Ltée.
Qui nous sommes
Un avenir plus sain nous pousse à innover. Ensemble, plus de 100 000 employés à travers le monde sont dédiés à faire progresser la science et à garantir à chacun l'accès aux soins de santé aujourd'hui et pour les générations à venir. Nos efforts aboutissent à plus de 26 millions de personnes traitées avec nos médicaments et plus de 30 milliards de tests réalisés avec nos produits de Diagnostique. Nous nous encourageons mutuellement à explorer de nouvelles possibilités, à favoriser la créativité et à conserver nos grandes ambitions, afin de fournir des solutions de santé qui changent des vies et ont un impact mondial.
Construisons ensemble un avenir plus sain.
Roche est un employeur offrant l'équité en matière d'emploi.
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