Senior Bioseparation Scientist — Lead Biologics Analytics

Element Materials Technology; Ann Arbor (MI); On-site; USD 140,000 - 210,000; Full time

Job summary

Element Ann Arbor is seeking a Senior/Principal Scientist – Bioseparation to lead advanced analytical method development for large molecule therapeutics in an onsite lab setting. You will drive method development, qualification, and transfer across discovery to late‑stage CMC, applying LC/UPLC/SEC/IEX/HIC, LC‑MS, CE‑SDS, cIEF, MAM workflows, and other biophysical techniques.

You will oversee hands‑on execution, provide scientific leadership, and collaborate with cross‑functional teams to ensure

Qualifications

• BS in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or related field required; Master's degree or higher preferred, but not required.
• Extensive industry experience in biologics analytical development is highly desirable.
• 8–15+ years of experience in biopharmaceutical or CRO analytical development with strong hands‑on expertise in bioseparation of large molecules.
• Deep technical expertise across analytical platforms including LC/UPLC/SEC/IEX/HIC/RP chromatography, LC-MS and high‑resolution MS, CE‑SDS, cIEF, SEC‑MALS, and complementary biophysical techniques.
• Strong experience in comparability, stability studies, and degradation pathway analysis for complex biologics.

Responsibilities

• Lead development, optimization, and troubleshooting of bioseparation‑based analytical methods for biologics across discovery, development, and late‑stage CMC.
• Perform hands‑on execution and technical leadership across modalities including proteins, mAbs, ADCs, and nucleic acids.
• Apply deep expertise in chromatography, MS, and biophysical techniques to support comprehensive characterization.
• Lead analytical strategy for complex biologics programs, including method development, qualification, validation, transfer, and stability studies.
• Ensure GMP‑compliant methods aligned with ICH Q2/Q6, USP, EP, and GMP; support regulatory submissions with quality data packages.
• Drive innovation in analytical science, including MAM workflows and high‑throughput LC‑MS platforms.
• Mentor junior scientists, troubleshoot challenges, and establish best practices in analytical development.

Skills

Bioseparation expert

LC/UPLC/SEC/IEX/HIC

LC-MS / high-res MS

CE-SDS / cIEF

Glycan PTM analysis

Regulatory documentation

Leadership / mentoring

Education

BS in Analytical Chemistry or related

MS preferred

Tools

MAM workflows

Automated LC-MS systems

GMP analytical methods

Job description

Element Ann Arbor is seeking a Senior/Principal Scientist – Bioseparation to lead advanced analytical method development for large molecule therapeutics in an onsite lab setting. You will drive method development, qualification, and transfer across discovery to late‑stage CMC, applying LC/UPLC/SEC/IEX/HIC, LC‑MS, CE‑SDS, cIEF, MAM workflows, and other biophysical techniques.

You will oversee hands‑on execution, provide scientific leadership, and collaborate with cross‑functional teams to ensure