PLS Scientist 3 - BioPharma

Pace® Analytical Services•Oakdale, MN

7d•$80,000 - $90,000•Onsite

About The Position

This is a full-time, onsite, Senior Scientist / Scientist 3 position located in Oakdale, MN, Monday through Friday, 8:30 a.m. - 5:00 p.m. Pace® Life Sciences delivers a comprehensive suite of contract CMC development, CTM manufacturing, regulatory compliance, consulting, and facility support services to the pharmaceutical, biopharmaceutical, and gene therapy industries. Operating across a network of CDMO sites, GMP analytical testing laboratories, and manufacturing support centers, we partner with clients to efficiently advance programs from early development through commercialization. Our experienced industry experts and continued investment in state-of-the-art facilities reflect our commitment to quality, speed, and reliability. United by a shared purpose, we bring meaningful value to patients, healthcare professionals, and health businesses worldwide by delivering services that support a safer, healthier future. The Scientist III / Senior Scientist will lead the design, optimization, and validation of analytical methods that support product development, regulatory submissions, and commercial readiness for biopharmaceuticals in a GMP environment.

Requirements

Bachelor's degree in Chemistry, Biochemistry, Analytical Chemistry, or a related scientific discipline with 8-10 years of relevant laboratory experience.
Master’s Degree in Chemistry, Biochemistry, Analytical Chemistry, or a related scientific discipline with 4-7 years of relevant laboratory experience.
Ph.D. in Chemistry, Biochemistry, Analytical Chemistry, or a related scientific discipline with 1-4 years of relevant laboratory experience.
Demonstrated expertise in bioanalytical method development and validation for biologics.
Strong hands-on experience with key biopharmaceutical analytical platforms
Familiarity with GMP, ICH guidelines, and regulatory expectations for biologics
Excellent technical writing skills and experience
Strong communication, leadership, and project management capabilities.

Responsibilities

Lead the development, optimization, and qualification/validation of analytical methods for biopharmaceutical drug substances and drug products, including peptides, oligos, proteins, mAbs, etc.
Serve as a technical expert for bioanalytical techniques, specifically ELISA, plate-based assays, SDS-PAGE, cell-based assays, qPCR, ddPCR, Sanger Sequencing, CE, cIEF, and similar.
Design scientifically sound method development strategies aligned with ICH Q2(R2) and evolving regulatory expectations for biologics.
Stay current with evolving regulatory expectations (ICH, USP, EP) and implement best practices.
Author and review method development reports, validation protocols, validation reports, and laboratory methods.
Provide scientific leadership during investigations, troubleshooting, and method lifecycle management.
Mentor and train junior scientists and contribute to building a culture of scientific excellence and continuous improvement.
Present data to and collaborate with client organizations.