Scientist I, Analytical Development and Clinical QC

Responsibilities

• Leading all aspects of analytical method validation, transfer, and compendial method verification across clinical development and method lifecycle stages.
• Developing and implementing strategies for analytical method validation, verification, transfer, and ongoing lifecycle management.
• Leading cross-functional teams in assay troubleshooting and OOS/OOT investigations during method validation and transfer activities.
• Designing investigation plans and supporting the execution of laboratory experiments to identify root causes and develop scientifically sound solutions.
• Reviewing analytical test procedures, method performance metrics, and testing results across the global testing network.
• Providing technical input into gap assessments and recommending remediation strategies, including post-validation or post-transfer method optimization when required.
• Authoring and reviewing analytical method transfer and validation protocols and reports for late-stage clinical and commercial programs.
• Providing subject matter expertise for regulatory submissions, agency interactions, and inspections.
• Serving as an analytical lead or supporting team member for CMC programs, particularly late-stage programs requiring rigorous cross-functional collaboration.
• Partnering with internal teams and external laboratories to ensure analytical methods are suitable, robust, compliant, and ready to support clinical and commercial manufacturing.

Requirements

• An advanced degree, PhD or MSc, in Biochemistry, Analytical Chemistry, Molecular Biology, Pharmaceutical Sciences, or a related scientific discipline.
• 1+ years of progressive experience in biologics analytical development across clinical and/or commercial stages.
• Demonstrated hands-on technical and strategic experience supporting biologic modalities such as monoclonal antibodies, bispecifics, and fusion proteins.
• Technical expertise across relevant analytical technologies, including chromatography (SEC, RP, IEX), capillary electrophoresis (CE-SDS, cIEF), spectroscopy (UV/Vis, fluorescence, CD), bioassays (binding and potency), and residual and impurity testing (HCP, DNA, residual Protein A).
• Experience with analytical method qualification and/or validation.
• Experience with compendial methods, particularly USP and EP requirements.
• Strong written and verbal communication skills, with the ability to develop clear technical reports, regulatory submission content, and presentations for both technical and non-technical stakeholders.
• High proficiency with Microsoft Office applications.
• Experience working within quality systems and an understanding of GxP-compliant documentation, ALCOA+ data integrity principles, OOS/OOT investigations, deviations, CAPA management, and audit readiness.
• Ability to work effectively in a highly collaborative, cross-functional environment and communicate complex analytical information clearly.

Preferred Qualifications

• Experience performing these activities in accordance with ICH Q2(R2).
• Knowledge of JP requirements.
• Experience with JMP, Empower, and SoftMax.
• A strong background in analytical method development, with scientific understanding of Critical Quality Attributes (CQAs), Quality by Design (QbD), Design of Experiments (DOE), statistical data analysis, and relevant analytical tools.
• Demonstrated experience with analytical method lifecycle ownership, including method development, qualification and validation in accordance with ICH Q2, transfer to QC laboratories and/or CMOs, and continued method verification supporting commercial control strategies.
• Experience overseeing analytical activities performed by CDMOs and CROs, including routine testing oversight, troubleshooting, investigations, and method qualification, validation, and transfer.
• Strong cGMP experience and knowledge of regulations and expectations related to analytical testing, validation, method transfer, and analytical laboratory operations.
• Strong knowledge of relevant regulatory guidance and expectations, including ICH Q5E, Q6B, and Q8-Q12; USP and EP requirements; FDA and EMA expectations for biologics; and GMP/GLP principles.
• Experience authoring or reviewing analytical content for CTD Module 3, IND/IMPD, and BLA/MAA submissions, including responses to regulatory agency questions.
• Experience developing CMC and analytical control strategies, including defining CQAs, establishing specifications, and implementing commercial control strategies aligned with QbD principles.
• Familiarity with digital laboratory systems and automation, including LIMS, ELN, Chromatography Data Systems, data visualization tools, and automation or robotics within analytical workflows.
• Experience applying AI-enabled tools and statistical software, such as JMP, to analytical development, data interpretation, or laboratory workflows.