Scientist II, LC Development, Biologics Analytical Development

Alexion•New Haven, CT

5d•Hybrid

About The Position

In this role, you will develop and optimize robust LC methods that define product quality for complex therapeutic proteins, enabling confident decisions from early development through commercialization. You will join a high-energy analytical development team that partners closely with Research & Development, Manufacturing, Quality Assurance and Quality Control. Your methods will drive release and stability strategies, resolve investigations, and strengthen regulatory submissions—turning scientific rigor into meaningful progress for patients.

Requirements

M.S. degree in Chemistry, Biochemistry, or a related biological science with 3+ years of relevant industry experience (or B.S. degree with 5+ years of experience)
Hands-on experience with (U)HPLC and practical knowledge of method development and optimization for protein therapeutics
Ability to take initiative in problem solving and apply an independent, scientific approach to method development and troubleshooting.
Ability to contribute technical content to regulatory submissions related to analytical sections.
Hands-on experience with LC systems from multiple vendors (e.g., Waters, Thermo Fisher), with strong proficiency in chromatography data systems (CDS) such as Empower and Chromeleon.
Experience developing and optimizing chromatographic methods for protein heterogeneity, aggregation, and degradation pathways.
Ability to organize and complete work independently with minimal direction.
Travel may be required on an as‑needed basis to support training and troubleshooting.
Ability to work in a laboratory environment, including performing tasks with or without accommodation such as lifting/carrying materials, working with biological and hazardous materials, gowning/degowning PPE, and maintaining accurate laboratory documentation.
Compliance with cGXPs and maintenance of clear, accurate, and complete laboratory records with strong attention to detail

Nice To Haves

Ph.D. with 1-3 years industry experience (particularly in CMC within pharmaceutical or biotech settings)
Experience with LC‑MS–based protein characterization, including intact mass and peptide mapping using high‑resolution MS platforms (e.g., Orbitrap, Q‑TOF).
Experience independently generating procedures, protocols, and reports related to analytical test methods.
Strong working knowledge of current regulatory guidelines (e.g., ICH Q2 and Q14) and cGMP requirements
Strong analytical thinking skills, including problem solving and data interpretation.
High emotional intelligence with clear, professional communication skills
Ability to recognize aberrant test or sample conditions and propose scientifically sound corrective actions.

Responsibilities

Build, optimize, and phase-appropriately qualify custom (U)HPLC methods (SEC, RP, ion exchange, HIC) to monitor critical quality attributes for therapeutic proteins with a focus on fitness for purpose and lifecycle readiness.
Independently operate, maintain, and troubleshoot UPLC/HPLC systems and detectors (UV, FL, ELSD, CD) to increase reliability, throughput, and data integrity in a cGMP setting.
Plan and implement method qualification, validation, and transfer to internal and external laboratories; diagnose and resolve performance issues to ensure successful adoption and sustainable performance.
Perform phase-appropriate testing to support release and stability, contribute to characterizations and investigations, and translate findings into clear, actionable recommendations.
Evaluate and implement new instruments, methods, and platforms to improve analytical capability and efficiency; introduce fit-for-purpose technologies that improve speed and insight.
Author SOPs, study plans, protocols, development reports, and draft content that supports regulatory submissions, ensuring clarity, traceability, and compliance.
Partner with R&D, Manufacturing, QA and QC to align analytical deliverables with program needs, enable process understanding, and support decision-making across development stages.
Stay current with evolving scientific principles and regulatory expectations; apply emerging knowledge to solve analytical problems and mentor standard methodologies within the team.