Senior Scientist, Analytical Development – GMP Method Transfer

Socket.dev; Bend (OR); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Paid time off

Retirement plan

Health insurance

Life insurance

Disability insurance

Employee Assistance Program

Pet insurance

Job summary

Serán BioScience in Bend, OR is seeking an experienced Senior Scientist to lead analytical method development for small molecule drugs through early and late stage development and into commercial manufacture. You will guide validation/transfer strategies and manage cross‑functional teams to deliver high‑quality data for CMC decisions.

The role requires 8–10 years of lab experience in a cGMP setting, strong HPLC/GC expertise, and the ability to mentor and collaborate in a fast‑paced environment.

Qualifications

• Bachelor’s degree in chemistry or related field with 10 years of hands‑on lab experience preferred; or Master’s degree with 8 years.
• Requires 5 years of GMP experience.
• 10–year hands‑on experience in a cGMP pharmaceutical lab is desirable.

Responsibilities

• Develop and optimize analytical methods for drug products across clinical development through commercial manufacture.
• Provide strategic validation and transfer guidance and design comprehensive plans.
• Perform analytical testing (GC, UHPLC/HPLC, water content, water activity, dissolution) for small molecules in GMP environment.
• Lead QC support, investigations (OOS/OOT), corrective actions and method lifecycle management.
• Plan and execute studies, generating data for CMC decision‑making.
• Prepare/review technical reports, methods, and protocols for regulatory‑ready documentation.
• Collaborate with QC, QA, Process Development, Project Management; communicate results to stakeholders.

Skills

Analytical method development

Cross-functional collaboration

Scientific curiosity

Communication skills

Problem solving

Education

Bachelor’s degree in chemistry

Master’s degree in chemistry

GMP experience

Tools

Empower

GC

HPLC

KF

XRPD

mDSC

Job description

Serán BioScience in Bend, OR is seeking an experienced Senior Scientist to lead analytical method development for small molecule drugs through early and late stage development and into commercial manufacture. You will guide validation/transfer strategies and manage cross‑functional teams to deliver high‑quality data for CMC decisions.

The role requires 8–10 years of lab experience in a cGMP setting, strong HPLC/GC expertise, and the ability to mentor and collaborate in a fast‑paced environment.