Scientist II, Quality Control

DanaherMadison, WI
87d

About The Position

At Aldevron, we deliver world-class CDMO services that accelerate the development of groundbreaking therapies. Our mission is to be the engine of innovation for genomic medicine pioneers. As a member of our team, you'll help bring life-changing innovations to life—impacting millions around the world. We bring together deep scientific expertise, an unwavering commitment to quality, and a collaborative spirit to drive progress. Whether you're launching your career or bringing years of experience, we value the unique perspective you bring. Join us and become part of a mission-driven team advancing science and unlocking human potential—one discovery at a time.

Requirements

  • Bachelor's degree in Scientific field + 5 years of experience working in a related laboratory environment OR Master's + 2 years OR Ph.D. + 1 year.
  • Knowledge of Quality Management Systems (ISO 13485 or cGMP) and Good Documentation Practices.
  • Experience in writing complex technical SOPs for clarity and ease of use.

Nice To Haves

  • Previous experience in Analytical Method Optimization and Transfer.
  • Experience with Electronic Laboratory Information Management Systems (LIMS).

Responsibilities

  • Independently perform complex QC assays for biological macromolecules (Concentration, Purity, Activity, Residual, Compendial) according to established standard operating procedures under minimal direction from the QC Supervisor.
  • Represent Aldevron in internal and external client meetings as a Subject Matter Expert in one or more analytical technical areas.
  • Lead investigations for Out of Specification / Out of Trend results using hypothesis tests and root cause analysis techniques; applies sustainable corrective actions.
  • Train and mentor Quality Control Scientists and Analysts.
  • Write and revise Standard Operating Procedures, Forms, Protocols, and Reports.

Benefits

  • Comprehensive health care programs.
  • Paid time off.

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What This Job Offers

Job Type

Full-time

Career Level

Mid Level

Industry

Computer and Electronic Product Manufacturing

Education Level

Bachelor's degree

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