Analytical Development Scientist II — GMP Method Expert

Serán BioScience; Bend (OR); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Paid time off

Retirement plan

Health insurance

Life insurance

Employee Assistance Program

Pet insurance

Job summary

Serán BioScience in Bend, Oregon seeks a Scientist II to support development, optimization, and validation of analytical methods for small molecule drug products in GMP environments.

You will work with UHPLC/HPLC, KF, and dissolution, transfer methods to QC, generate data for CMC decisions, and collaborate across QC, QA, and Process Development. This role offers opportunities to influence analytical strategy and partner with internal and external teams.

Qualifications

• Proven analytical method development experience (preferably HPLC) with at least 1-2 years in a cGMP pharmaceutical industry lab.
• Demonstrates intermediate expertise with analytical equipment (e.g. disso, KF, GC, LC, XRPD, or mDSC; preferred LC and GC).
• Conveys understanding of USP, ICH, and EP guidance as they pertain to method validation/qualification/transfer and general chapters for relevant instrumentation.

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.

Skills

Analytical method development

HPLC

Scientific curiosity

Analytical instrumentation

USP/ICH/EP knowledge

Communication skills

Organization/time management

Cross-functional collaboration

Empower

Education

Bachelor's degree in chemistry

Master's degree in chemistry

GMP experience

Tools

Empower

Microsoft Office

Job description

Serán BioScience in Bend, Oregon seeks a Scientist II to support development, optimization, and validation of analytical methods for small molecule drug products in GMP environments.

You will work with UHPLC/HPLC, KF, and dissolution, transfer methods to QC, generate data for CMC decisions, and collaborate across QC, QA, and Process Development. This role offers opportunities to influence analytical strategy and partner with internal and external teams.