Analytical Development Scientist II — GMP Method Expert

Serán Bioscience, LLC; Bend, Northern (OR, KY); Hybrid; USD 85,000 - 120,000; Full time

Benefits offered by this job

Paid time off

Retirement plan

Health plans

Life and disability insurance

Employee Assistance Program

Pet insurance

Job summary

Serán BioScience, LLC in Bend, Oregon is seeking a Scientist II to support development, optimization, and validation of analytical methods for small molecule drug products in early and late phase clinical R&D, enabling GMP Clinical Release and Stability programs.

The role emphasizes collaboration across QC, QA, Process Development, and Project Management, delivering high-quality data, writing reports, and contributing to strategy. A strong background in HPLC and GMP is required.

Qualifications

• Bachelor’s or Master’s in chemistry or related field with hands-on lab experience
• GMP experience required
• Experience with analytical methods (HPLC) and instrument platforms

Responsibilities

• Perform analytical testing (UHPLC/HPLC, KF, Water Activity, Dissolution) in GMP environment
• Develop and optimize methods for drug products across clinical stages
• Transfer methods to QC or partner labs and ensure robustness
• Plan and troubleshoot laboratory studies, generating data for CMC decisions
• Prepare and review technical reports and protocols
• Collaborate with QC, QA, Process Development, PM and communicate results
• Provide analytical SME leadership and strategy support
• Maintain GMP training certification
• Provide regular updates to management
• Identify process improvements and out-of-trend data

Skills

Analytical method development

cGMP lab experience

Cross-functional collaboration

Scientific curiosity

Analytical instrumentation (LC/GC)

USP/ICH/EP knowledge

Communication skills

Attention to detail

Time management

Problem-solving

Adaptability

Education

Bachelor's degree in chemistry or related field

Master's degree in chemistry or related field

GMP experience

Tools

Empower

Microsoft Office

Job description

Serán BioScience, LLC in Bend, Oregon is seeking a Scientist II to support development, optimization, and validation of analytical methods for small molecule drug products in early and late phase clinical R&D, enabling GMP Clinical Release and Stability programs.

The role emphasizes collaboration across QC, QA, Process Development, and Project Management, delivering high-quality data, writing reports, and contributing to strategy. A strong background in HPLC and GMP is required.