Senior Analytical Development Scientist (GMP)

Serán BioScience; Bend (OR); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Paid time off

Retirement plan

Health plans

Life insurance

Disability coverage

Pet insurance

Job summary

Serán BioScience in Bend, Oregon seeks an industry-experienced Senior Scientist to support development, optimization, validation and transfer of analytical methods for small molecule drug products across early to late phase programs, enabling GMP Clinical and Commercial Release and Stability testing. The role shapes analytical strategy and data quality for CMC decisions.

The candidate will lead method development, validation planning, and cross-functional collaboration, acting as SME in

Qualifications

• 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 understanding of USP, ICH, and EP guidance as they pertain to method validation/qualification/transfer.

Responsibilities

• Develop and optimize analytical methods for drug products across development stages.
• Provide guidance for method validation and transfer plans.
• Initiate analytical testing (GC, UHPLC/HPLC, Water Content, Water Activity, Dissolution) in GMP environment.
• Lead QC lab support and investigations (OOS/OOT).
• Plan and execute studies, generate data for CMC decisions.
• Review technical reports and regulatory-ready documentation.

Skills

Method development

HPLC

GC

Cross-functional

Empower

MS Office

Communication

Problem-solving

Education

Bachelor's in Chemistry

Master's in Chemistry

GMP experience

Tools

QToF or LC–MS

PowerPoint

Job description

Serán BioScience in Bend, Oregon seeks an industry-experienced Senior Scientist to support development, optimization, validation and transfer of analytical methods for small molecule drug products across early to late phase programs, enabling GMP Clinical and Commercial Release and Stability testing. The role shapes analytical strategy and data quality for CMC decisions.

The candidate will lead method development, validation planning, and cross-functional collaboration, acting as SME in