Analytical Development Scientist II: GMP Method Dev

Seranbio; Bend (OR); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

PTO accrual

Retirement plan

Health plans

Life insurance

Disability insurance

Employee assistance program

Pet insurance

Job summary

Serán BioScience seeks a Scientist II to support analytical method development, optimization, and validation for small molecule drug products in early and late phase clinical R&D. You will collaborate across QC, QA, Process Development, and Project Management to shape analytical strategy and deliver high-quality data for GMP Clinical Release and Stability programs.

The role emphasizes method development (HPLC/LC), transfer, documentation, and SME leadership in analytical development, with a

Qualifications

• Analytical method development experience (preferably HPLC) in a cGMP pharmaceutical lab (1–2 years).
• Scientific curiosity and willingness to learn.
• Experience with analytical equipment (e.g., Dissolution, KF, GC, LC; LC/GC preferred).

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.

Skills

Analytical method development

HPLC

Data analysis

Communication

Organization

Time management

Problem solving

Collaboration

Empower

Microsoft Office

Education

Bachelor’s degree in chemistry or related field

Master’s degree in chemistry or related field

Tools

LC

GC

KF

Dissolution

Dissolution tester

Empower

Microsoft Office Suite

Job description

Serán BioScience seeks a Scientist II to support analytical method development, optimization, and validation for small molecule drug products in early and late phase clinical R&D. You will collaborate across QC, QA, Process Development, and Project Management to shape analytical strategy and deliver high-quality data for GMP Clinical Release and Stability programs.

The role emphasizes method development (HPLC/LC), transfer, documentation, and SME leadership in analytical development, with a