PLS Principal Scientist - BioPharma

Principal Scientist

Shift: Monday through Friday, 8:00 AM - 5:00 PM

Are you ready to work making the world a safer, healthier place? Join our mission to continuously move science forward; to innovate and advance all aspects of our business to improve the health and safety of our communities and lives.

This is a full-time, onsite position located in Oakdale, MN, Monday through Friday, 8:00 a.m.

- 5:00 p.m.

Compensation: $85,000 - $95,000 per year

The salary for this position reflects a variety of factors. Compensation will be determined based on the candidate's geographic location, relevant experience, education, skills, and alignment with internal equity. Market conditions, budgetary considerations, and organizational compensation guidelines may also influence the final offer.

Make an Impact. Build a Career.

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.

Summary The Principal 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. This role is essential for the development and validation of analytical methods, executing testing plans, and interpretation of data to support pharmaceutical and biopharmaceutical product development and quality control.

Job 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 HPLC, IC, and GC.
• 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.
• Provide strategic direction for scientific research and development, oversee large-scale and complex research initiatives and set benchmarks for scientific excellence within the organization.
• Proactively lead cross-functional teams and projects.
• Articulate complex scientific ideas to diverse audiences.

Job Qualifications:

• Bachelor's degree in Chemistry, Biochemistry, Analytical Chemistry, or a related scientific discipline with 10-15 years of relevant laboratory experience.
• Master's Degree in Chemistry, Biochemistry, Analytical Chemistry, or a related scientific discipline with 8-10 years of relevant laboratory experience.
• Ph.D. in Chemistry, Biochemistry, Analytical Chemistry, or a related scientific discipline with 5-8 years of relevant laboratory experience.
• Demonstrated expertise in bioanalytical method development and validation for biologics.
• Strong hands-on experience with key biopharmaceutical analytical platforms
• Expertise with GMP, ICH guidelines, and regulatory expectations for biologics
• Excellent technical writing skills and experience
• Strong communication, leadership, and project management capabilities.

PHYSICAL/MENTAL REQUIREMENTS:
The physical demands described herein are representative of those that must be met by an…