Quality Control Scientist II

Bend, Oregon /
Quality – Quality Control /
Full-time Exempt
/ On-site
Serán is searching for an experienced Scientist to join our Quality Control team! The role of Scientist II supports the laboratory's ongoing sample testing performed by the Quality Control department in support of GMP practices and customer satisfaction. Successful candidates will demonstrate expertise with specific laboratory equipment, techniques, and methods for technical review and data analytics for the development and manufacturing of pharmaceutical therapies. Qualified candidates will demonstrate at least five years of hands-on instrumentation experience with a variety of analytical equipment within a GMP laboratory environment. Those demonstrating these minimum qualifications with or without pharmaceutical experience are encouraged to apply.

Supervisory Responsibilities

    • May lead a project based on requirements
    • May interview and train new staff
    • May oversee the daily workflow of assigned projects

Duties and Responsibilities

    • Acts as internal SME for instrumentation and/or process with a focus on more complex analytical techniques and methods
    • Conducts technical review of validation activities, release testing, and stability testing data
    • Performs technical review of validation transfer documents, protocols, and summary reports
    • Interfaces with clients on technical matters when required
    • Interfaces with laboratory management as technical lead for OOS investigations
    • All other related duties as assigned

Required Skills and Abilities

    • Demonstrates intermediate expertise with analytical equipment (e.g., Disso, cKF, HPLC, XRPD, mDSC)
    • Strong verbal and written communication skills
    • Strong internal and external customer relations skills
    • Excellent organizational skills and attention to detail
    • Excellent time management skills with a proven ability to meet deadlines
    • Strong analytical and problem-solving skills
    • Ability to train and mentor junior scientists on areas of expertise
    • Ability to prioritize tasks and manage multiple project activities
    • Ability to function well in a high-paced and at times stressful environment
    • Proficient with Microsoft Office Suite or related software

Education and Experience

    • Minimum 5 of experience with HPLC, GC, cKF, Dissolution, IR, pXRD testing (equipment and documentation, at least 2 different technology platforms) 
    • Experience demonstrated thorough understanding of instrument function and theory for the technology platforms used
    • Bachelor’s degree in chemistry, physics, or related scientific discipline, with analytical lab coursework required
    • Requires minimum 5 years of GMP experience, with minimum of 5 years hands on experience with analytical instrumentation

Physical Requirements

    • Prolonged periods of sitting at a desk and working on a computer
    • Prolonged periods of standing or sitting while monitoring laboratory equipment and preparing materials for analysis
    • Must be able to lift up to 15 pounds at times