Scientist I, Analytical Development and Clinical QC

Alexion; New Haven (CT); On-site; USD 120,000 - 190,000; Full time

Job summary

AstraZeneca plc is seeking an experienced Biologics Analytical Scientist to advance late-stage biologics from Phase 3 through commercialization. You will lead analytical method validation, transfer, and lifecycle activities, working with cross-functional teams to ensure robust, compliant methods across clinical and commercial programs.

The role requires deep technical expertise in analytical technologies, regulatory alignment, and a collaborative approach to solving complex challenges in a

Qualifications

• PhD or MSc in Biochemistry, Analytical Chemistry, Molecular Biology, Pharmaceutical Sciences, or related field.
• 1+ years of progressive experience in biologics analytical development.
• Experience with biologic modalities such as mAbs, bispecifics, fusion proteins.

Responsibilities

• Lead analytical method validation, transfer, and compendial verification across clinical and late-stage programs.
• Develop strategies for validation, verification, transfer, and lifecycle management.
• Lead cross-functional teams in troubleshooting and OOS/OOT investigations during validation/transfer.
• Design investigation plans and execute experiments to identify root causes and solutions.
• Review analytical test procedures, method performance, and testing results for global networks.
• Provide input on gap assessments and remediation strategies post-validation/transfer.
• Author/review validation and transfer protocols and reports for late-stage programs.
• Provide SME support for regulatory submissions, agency interactions, and inspections.
• Serve as analytical lead or team member for CMC programs, especially late-stage.
• Collaborate with internal teams and external labs to ensure robust, compliant methods.

Skills

Biologics analytics

Method validation/transfer

OOS/OOT investigations

GxP/regulatory knowledge

Data analysis software

Project leadership

Education

PhD in Biochemistry/Analytical Chemistry/related

MSc in Biochemistry/Analytical Chemistry/related

Tools

JMP

Empower

SoftMax

LIMS

ELN

Job description

Join our Late Stage Analytical team and play a key role in advancing biologics through late-stage clinical development and commercialization. In this role, you will bring deep analytical expertise and help shape analytical strategies across the CMC lifecycle, with a particular focus on method validation, verification, transfer, and lifecycle management.

You will lead strategies for the validation, verification, and transfer of analytical and compendial methods supporting clinical and commercial biologics. You will also help define the overall analytical testing strategy throughout the product lifecycle, applying your technical expertise to solve complex analytical challenges and ensure robust, phase-appropriate methods.

As a subject matter expert, you will provide hands‑on support for assay troubleshooting and OOS/OOT investigations, including developing investigation plans, executing laboratory experiments, interpreting data, and supporting associated GMP documentation.

Working cross‑functionally, you will collaborate closely with PDCS teams, Regulatory, Quality Assurance, and external QC laboratories. You will provide analytical expertise for regulatory submissions and interactions related to method validation, verification, and transfer activities.

You may also serve as an analytical functional lead or supporting team member for CMC programs, with a particular focus on Phase 3 through commercialization and the associated end‑to‑end analytical activities.

You will be responsible for:

• 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.

You will need to have:

• 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, such as SEC, RP, and IEX.
  • Capillary electrophoresis, including CE‑SDS and cIEF.
  • Spectroscopy, such as UV/Vis, fluorescence, and CD.
  • Bioassays, including binding and potency assays.
  • Residual and impurity testing, including HCP, DNA, and residual Protein A.
• Experience with analytical method qualification and/or validation. Experience performing these activities in accordance with ICH Q2(R2) is a plus.
• Experience with compendial methods, particularly USP and EP requirements. Knowledge of JP requirements is preferred.
• 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 with JMP, Empower, and SoftMax is preferred.
• 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.

We would prefer for you to have:

• 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.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life‑changing medicines. In‑person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Why AstraZeneca:

Here, courage, curiosity, and collaboration fuel a relentless focus on transforming cancer outcomes, powered by a pipeline that fuses cutting‑edge science with advanced technology. You will work in an environment where unexpected teams come together to spark bold ideas, backed by meaningful investment and a clear path from discovery to impact. We value kindness alongside ambition, and we empower leaders at every level to ask sharp questions, take smart risks, and turn data into decisions that help patients sooner.

Date Posted

09-Nov-2026

Closing Date

17-Jan-2027

Our mission to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.