À propos de ce poste Analytical Development Scientist II chez Seranbio
Seranbio · Sur site · Bend, Oregon
Serán is seeking a Scientist II who will support the development, optimization, and validation of analytical methods used to characterize small molecule drug products for early and late phase clinical R&D to support client GMP Clinical Release and Stability programs. The work performed in this role will help to shape analytical strategy, collaboration across functions, and deliver high‑quality data that enables the success of early/late phase clinical programs
Duties and Responsibilities
- Perform analytical testing such as UHPLC/HPLC, KF, Water Activity, Dissolution to support small molecules drug product development in GMP environment
- Develop and optimize methods for drug products and APIs across early phase and late phase clinical stages
- Execute method transfers to QC or partner labs, ensuring robustness and compliance.
- Plan, troubleshoot, and independently execute laboratory studies, generating high‑quality data for CMC decision‑making.
- Prepare and review technical reports, analytical methods, and protocols, contributing to regulatory‑ready documentation.
- Collaborate with cross‑functional teams (QC, QA, Process Development, Project Management) and communicate results to internal and external stakeholders.
- Act as a subject matter expert (SME) in analytical development, providing technical leadership and supporting analytical strategy.
- Initiate, draft, and perform testing for discrepancy reports; as necessary.
- Maintain GMP training certification to be able to perform work in a GMP laboratory
- Provide regular updates to management on projects
- Identify opportunities for process improvements and propose solutions
- Identifies out of trend data.
- Responsibilities may increase in scope to align with company initiatives.
Required Skills & Abilities
Education & Experience
Physical Requirements
Visit https://www.seranbio.com/careers to learn more about company culture and the community of Bend, Oregon.
Applicants must be authorized to work for an employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
Benefits Summary:
Serán employees accrue over four weeks of paid time off annually. Employer contributions to a retirement account begin after 90 days and do not require an employee match or vesting period. Various health plans allow employees to find the best coverage for their individual or family needs with minimal employee contributions. Serán covers each employee with basic life and long-term disability, giving access to increase or add coverage. An Employee Assistance Program provides support for all things related to our employees’ wellbeing, along with access to pet insurance.
The Corporate Headquarters of Serán BioScience are located at 63047 Layton Ave, Bend, OR 97701
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