Senior Analytical Development Scientist - GMP Method Transfer

Serán Bioscience, LLC; Bend, Northern (OR, KY); Hybrid; USD 120,000 - 180,000; Full time

Benefits offered by this job

PTO 4 weeks

Retirement plan after 90 days

Health coverage

Life & disability insurance

Employee Assistance Program

Pet insurance

Job summary

Serán BioScience seeks an experienced Senior Scientist to develop, optimize, validate and transfer analytical methods for small‑molecule drugs across early to commercial stages. You will shape analytical strategy, support cross‑functional teams, and drive high‑quality data for GMP release and stability programs.

You will lead method development and validations in a fast‑paced GMP environment, mentoring teams and contributing to regulatory‑ready documentation.

Qualifications

• Experience developing analytical methods (HPLC/GC) in a cGMP pharmaceutical lab.
• Strong communication and cross‑functional collaboration skills.
• Familiarity with USP/ICH/EP guidance for method validation/transfer.

Responsibilities

• Develop and optimize analytical methods across early to commercial stages.
• Provide strategic guidance for validation and transfer plans.
• Perform GC, UHPLC/HPLC, Water Content, Water Activity, and Dissolution analyses in GMP environment.
• Lead QC laboratory support, OOS/OOT investigations, and method lifecycle management.
• Plan and execute studies, generating data for CMC decisions.
• Prepare and review technical reports, methods, and protocols for regulatory-ready documentation.
• Collaborate with QC, QA, Process Development, and Project Management; communicate results to stakeholders.
• Act as SME in analytical development and support analytical strategy.
• Draft and perform testing for discrepancy reports as needed.

Skills

Analytical method development

Cross-functional collaboration

Analytical equipment proficiency

Communication skills

GMP knowledge

Time management

Mentoring

Education

Bachelor’s in chemistry or related

Master’s in chemistry or related

GMP experience

Tools

Empower

Microsoft Office

LC/GC instruments

Dissolution instruments

XRPD/mDSC

Job description

Serán BioScience seeks an experienced Senior Scientist to develop, optimize, validate and transfer analytical methods for small‑molecule drugs across early to commercial stages. You will shape analytical strategy, support cross‑functional teams, and drive high‑quality data for GMP release and stability programs.

You will lead method development and validations in a fast‑paced GMP environment, mentoring teams and contributing to regulatory‑ready documentation.