PLS Scientist 3 - BioPharma

Job Summary

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.

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 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.

Job Qualifications

• 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.

Benefits

• Competitive salaries
• Medical, dental, vision 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, wellness program, flexible spending accounts
• Tuition reimbursement, Employee Assistance program, parental leave
• Optional legal coverage and ID theft

Physical/Mental Requirements

• Work in a lab and office setting
• Mobility to work in a lab and office setting
• Erecting up to 20 pounds of force occasionally and/or up to 10 pounds of force frequently to lift, carry, push, pull or move objects
• Stamina to sit for extended periods of time
• Use standard office and lab equipment
• Read printed materials and computer screens
• Communicate in person or over the telephone

Working Environment

• Work is performed in a lab and office setting
• Work is subject to chemicals, fumes, gases, noxious odors, and related items in a lab and sample setting