Roche · 3 months ago
Technical Development Senior Principal Scientist
Roche is a leading company in the pharmaceutical industry, and they are seeking a Technical Development Senior Principal Scientist to join their Analytical Development and Quality Control department. The role involves leading a multidisciplinary team to develop strategies for controlling and characterizing biological therapeutics, collaborating on CMC project deliverables, and authoring regulatory submissions.
BiotechnologyHealth CareHealth DiagnosticsOncologyPharmaceuticalPrecision Medicine
Responsibilities
Lead a team of analytical, biological, and quality control scientists in the development of the strategy and methods required for control system testing and characterization of biological therapeutics
Support and collaborate with technical development team members on early and/or late stage CMC deliverables
Author regulatory submissions and support Health authority information requests
Strive for molecule CQA understanding through analytical characterization and collaborations with research, non-clinical and clinical organization personnel
Build and maintain collaborations with key partners, (e.g., Research, quality, regulatory, and other technical development functions and teams)
Qualification
Required
PhD in chemistry, biochemistry, biology, or related field with at least 8 years' experience; or B.S./M.S. with a minimum of 11 years' experience in the pharmaceutical/biopharmaceutical industry
In-depth scientific and technical knowledge and experience in the analytical method development/validation of biologics covering a wide array of analytical techniques and cGMP
Demonstrated ability to author regulatory submissions and support Q&A from health authorities
Ability to work independently and challenge the status quo, handle multiple projects, prioritize and delegate effectively, adapt to changes quickly, and work collaboratively on cross-functional teams
Strong written and verbal communication skills are required
Preferred
PhD or Master's degree
Benefits
Relocation benefits are available for this job posting.
A discretionary annual bonus may be available based on individual and Company performance.
Company
Roche
Roche is a pharmaceutical and diagnostics company that offers medicines and diagnostic tests for various medical conditions and diseases.
H1B Sponsorship
Roche has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (12)
2024 (9)
2023 (6)
2022 (2)
2021 (2)
Funding
Current Stage
Public CompanyTotal Funding
$7.79BKey Investors
SoftBankSCALE AINovartis
2021-08-04Post Ipo Equity· $5B
2020-12-07IPO
2020-05-06Post Ipo Equity· $0.5M
Leadership Team
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