Director Analytical Development Biologics Jobs (NOW HIRING)

Are you ready to elevate chromatographic science to accelerate life-changing biologics for people with the greatest unmet need? 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. Could your next method power a pivotal study or unlock a critical root cause?

Accountabilities:

Chromatography Method Development:

• 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.

Instrumentation Ownership:

• 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.

Method Qualification, Transfer, and Troubleshooting:

• 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.

Analytical Testing and Investigations:

• Perform phase-appropriate testing to support release and stability, contribute to characterizations and investigations, and translate findings into clear, actionable recommendations.

Technology Innovation:

• Evaluate and implement new instruments, methods, and platforms to improve analytical capability and efficiency; introduce fit-for-purpose technologies that improve speed and insight.

Regulatory and Documentation Excellence:

• Author SOPs, study plans, protocols, development reports, and draft content that supports regulatory submissions, ensuring clarity, traceability, and compliance.

Cross-Functional Collaboration:

• 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.

Scientific Leadership:

• Stay current with evolving scientific principles and regulatory expectations; apply emerging knowledge to solve analytical problems and mentor standard methodologies within the team.

Essential Skills/Experience:

• 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 asneeded 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

Desirable Skills/Experience:

• Ph.D. with 1-3 years industry experience (particularly in CMC within pharmaceutical or biotech settings)
• Experience with LCMS-based protein characterization, including intact mass and peptide mapping using highresolution MS platforms (e.g., Orbitrap, QTOF).
• 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.

When we put unexpected teams in the same room, we spark ambitious 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 four 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 bold world!

Why AstraZeneca:

Join a science-led, mission-driven organization where advanced analytics and chromatography translate directly into patient impact. You will work at the intersection of cutting-edge platforms, rigorous quality standards, and real-world needs-combining the agility of a biotech with the reach of a global biopharma. We bring diverse experts together to tackle the hardest problems in biologics, equip teams with modern LC, LCMS and digital tools, and value kindness alongside ambition so ideas become medicines faster and smarter. Your craft will scale beyond the bench to help people with severe, underserved conditions live fuller lives.

If you are ready to shape high-performance LC methods that accelerate transformative biologics to patients, step forward and make your impact with us today.

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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.