Associate Director, Analytical Development and Clinical QC

AstraZeneca; New Haven (CT); On-site; USD 180,000 - 230,000; Full time

Job summary

Alexion, now part of AstraZeneca, seeks a senior analytical leader to drive late-stage strategy across CMC programs including method transfer/validation and regulatory submissions. You will lead cross-functional teams, oversee QC testing, and author CTD modules and responses to health authorities.

The role emphasizes strong technical expertise in chromatography, bioassays, and compendia compliance (USP/EP/JP) and requires proven experience managing development projects through the biologics

Qualifications

• Advanced degree with 8–12+ years in biologics analytical development across clinical and commercial stages.
• Experts in monoclonal antibodies, bispecifics, fusion proteins, with strong chromatography and bioassay skills.
• Experience with USP/EP/JP compendia and ICH Q2-compliant method development.

Responsibilities

• Lead analytical method validation, transfers, and compendia verifications across stages.
• Serve as analytical lead for CMC programs with cross-functional collaboration.
• Own end-to-end strategy for late-stage biologics, including control strategy and QC testing supervision.
• Oversee analytical QC testing, data analysis, and risk identification in the CMC program.
• Lead regulatory authoring for CTD modules and respond to health authority queries.

Skills

Analytical leadership

Regulatory writing

CMC strategy

Method transfer/validation

GxP documentation

ALCOA+ data integrity

ICH Q2 knowledge

Chromatography

QA/CMO collaboration

Team mentorship

Education

PhD in Biochemistry or related field

Tools

LIMS

ELN

Chromatography Data Systems

JMP (stats software)

Job description

This position will play a key leadership role in Alexion’s Late Stage Analytical team, which requires analytical expertise and proven success in management of development projects through the CMC lifecycle. This position will lead multiple projects in parallel and working closely with other PDCS teams, Regulatory, QA and external QC laboratories as a lead to designing the strategy of late-stage analytical activities including method transfer/validation, compendia method verification, and overall testing strategy throughout all phases of the product lifecycle. Moreover, this position will lead to authoring regulatory filing in relevant analytical sections with a focused understanding of country‑specific requirements!

Responsibilities

• Leading all aspects of analytical method validation, transfers, and compendia method verifications across all stages of clinical development and method life‑cycle stages
• Analytical lead for CMC programs, emphasizing late‑stage programs, which may be internal or external with cross functional collaboration.
• Analytical end‑to‑end strategy for key late‑stage biologics programs including analytical control strategy, method lifecycle and QC testing supervision, problem resolution and inquiries, and key BLA/commercial analytical
• Supervision of analytical QC testing, problem‑solving, and data analysis are conducted for the CMC program. This provides oversight of the analytical program's health. It also helps identify potential analytical and program risks early.
• Leading independently regulatory authoring for both medical and market‑facing submissions for all markets including responses to health authority queries and requests for information

Qualifications

• Advanced degree (PhD or MSc) in Biochemistry, Analytical Chemistry, Molecular Biology, Pharmaceutical Sciences, or related field with 8–12+ years of progressive experience in biologics analytical development across clinical and commercial stages
• Validated first‑hand expert knowledge and technical proficiency with monoclonal antibodies, bispecifics, fusion proteins.
• Technical expertise in chromatography (e.g., SEC, RP, IEX), capillary electrophoresis (CE‑SDS, cIEF), spectroscopy (UV/Vis, fluorescence, CD), bioassays (binding, potency), and residuals/impurities testing (HCP, DNA, residual ProteinA)
• Compendia method experience emphasizing USP, EP and JP compliance
• Strong written and verbal skills for clear reports, regulatory submissions, and presentations to technical and non‑technical collaborators
• Demonstrated success in method development, qualification/validation (per ICH Q2), transfer to QC/CMOs, and continued verification for commercial control strategies.
• Strong command of ICH (Q5E, Q6B, Q8–Q12), USP/EP, FDA/EMA expectations for biologics, GMP/GLP compliance, and authoring/reviewing CTD Module3, IND/IMPD, BLA/MAA analytical sections and responses to agency queries.
• Proficiency with GxP compliant documentation, ALCOA+ data integrity principles, OOS/OOT handling, deviation/CAPA management, and audit readiness
• Ability to define critical quality attributes (CQAs), build specifications, and implement control approaches aligned with Quality by Build (QbB)

Preferred Qualifications

• Experience in microbiology assays (e.g., required day of harvest, bioburden, endotoxin, sterility, and CCIT)
• Background in analytical method development and sound scientific understanding of Critical Quality Attributes/QbD/DOE principles as well as statistical data analysis and relevant tools
• Experience leading all aspects of CDMO/CRO analytical activities including routine testing oversight, troubleshooting and investigations and method qualification, validation, and transfer.
• Experience in country specific compendia requirements and knowledge of CHP
• Experience leading ICH stability programs (Q1), shelf‑life modeling, and projections and related statistical approaches.
• Experience in extended characterization and comparability including forced degradation studies for process comparability.
• Familiarity with LIMS, ELN, Chromatography Data Systems, data visualization, and automation/robotics in analytical workflows
• Expertise with AI tools and statistical software, for example JMP
• Track record of building, mentoring, and developing high‑performing teams; resource planning, and performance management

The duties of this role are generally conducted in a lab environment. As is typical of a lab‑based role, employees will work comfortably in a controlled environment with and around biological, infectious, and hazardous materials; gown/degown PPE; use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non‑linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

Our mission is 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.