Serán is expanding its Bend, Oregon campus with a new GMP manufacturing facility and is seeking an industry-experienced Senior Scientist who will support the development, optimization, validation and transfer of analytical methods used to characterize small molecule drug products for early and late phase clinical R&D to support client GMP Clinical and Commercial 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 /commercial manufacturing.
Duties and Responsibilities- Independently develop and optimize analytical methods for drug products across early- and late-stage clinical development through commercial manufacturing.
- Provide strategic guidance for method validation and transfer activities and design comprehensive validation and transfer plans.
- Initiate and perform analytical testing such as GC, UHPLC/HPLC, Water Content, Water Activity, Dissolution to support small molecules drug product development in GMP environment
- Lead technical support efforts for QC laboratories, driving OOS/OOT investigations, corrective actions, and analytical method lifecycle management.
- 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- Proven analytical method development experience (preferably HPLC and GC) with at least 8-10 years in a cGMP pharmaceutical industry lab
- Scientific curiosity and willingness to learn
- Demonstrates intermediate expertise with analytical equipment (e.g. disso, KF, GC, LC, XRPD, or mDSC; preferred LC and GC)
- Conveys general understanding of USP, ICH, and EP guidance as they pertain to method validation/qualification/transfer and general chapters for relevant instrumentation
- Excellent verbal and written communication skills
- Excellent organizational skills and attention to detail
- Excellent time management skills with a proven ability to meet deadlines
- Strong analytical and problem-solving skills.
- Ability to function well in a fast pace work environment
- Demonstrated ability to collaborate, mentor, and work in cross-functional teams
- Accepts feedback and constructively manages conflict
- Proficient with Empower
- Proficient with Microsoft Office Suite or related software
Education & Experience- Bachelor's degree in chemistry or related field, with 10 years of hands-on lab experience preferred; or
- Master's degree in chemistry or related field, with 8 years of hands-on lab experience preferred.
- Requires 5 year of GMP experience.
Physical Requirements- Prolonged periods of sitting or standing at a desk and working on a computer.
- Prolonged periods of standing or sitting while monitoring laboratory equipment.
- Must be able to lift up to 15 pounds at times.
- Adheres to consistent and predictable in-person attendance.
Visit https://www.seranbio.com/careers to learn more about company culture and the community of Bend, Oregon.
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
