PLS Principal Scientist - BioPharma

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.
• 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

• Mobile to work in a lab and office setting.
• Exert up to 20 pounds of force occasionally and/or up to 10 pounds of force frequently to lift, carry, push, pull or move objects.
• Vision to read printed materials and computer screens.
• Hearing and speech to communicate in person or over the telephone.

Benefits

• Competitive salaries.
• Medical, dental, vision, and disability insurance.
• 401K retirement savings plan (100% vested immediately in the employer match).
• Life, disability, and voluntary benefits.
• Paid time off for holiday, sick, and vacation days.
• HSA and wellness program.
• Flexible spending accounts.
• Tuition reimbursement.
• Employee Assistance program.
• Parental leave.
• Optional legal coverage and ID theft.

About the Role

This is a full-time, onsite, Principal Scientist position located in Oakdale, MN, Monday through Friday, 8:00 a.m. - 5:00 p.m.

Pay

$85,000 - $95,000 per year

Schedule

Monday through Friday, 8:00 a.m. - 5:00 p.m.