Development Scientist II, Analytical Development and Clinical QC

Are you ready to turn advanced LC/MS data into decisions that move life-changing biologics to patients faster?

In this role, you will be a core contributor to the protein characterization strategy that informs molecule design, process development, comparability, and clinical readiness. Your work will help translate complex mass spectrometry results into clear guidance for teams across discovery, development, and manufacturing.

You will join a collaborative group that values scientific rigor, speed, and clarity! Expect to work hands-on with HPLC/UPLC ESI ToF, Orbitrap, and MALDI ToF platforms, while partnering closely with R&D, Analytical Sciences, Process Development, Manufacturing, QA/QC, and CROs. Can you see yourself guiding decisions with intact mass profiles, peptide maps, and PTM insights that reduce risk and accelerate regulatory submissions?

Accountabilities:

LC/MS Protein Characterization:

• Implement intact mass, subunit, peptide mapping, glycan, PTM, disulfide bond, and sequence variant analyses for biotherapeutics to define product quality attributes and comparability.

Method Development and Qualification Support:

• Contribute to development, optimization, and qualification of LC/MS methods under mentorship from senior scientists to improve robustness and cycle time.

Scientific Problem Solving:

• Troubleshoot straightforward to moderately challenging analytical issues, drive root-cause analyses, and propose pragmatic solutions that keep studies on track.

Cross-Functional Impact:

• Represent Protein Characterization as a technical contributor in development team meetings; translate data into options and risks that inform process and clinical strategies.

Documentation and Regulatory Contribution:

• Draft and review SOPs, study protocols, and technical reports; contribute to CMC documentation by ensuring clear narratives, data integrity, and right-first-time execution.

Technology and Workflow Improvement:

• Evaluate and implement new instruments, methods, and analytical strategies that enhance sensitivity, throughput, and data quality across protein characterization workflows.

External Collaboration and Study Coordination:

• Coordinate activities with external research or testing laboratories, including sample shipments, method transfer support, and timeline tracking to meet program landmarks.

Operational Excellence and Safety:

• Plan and prioritize work across parallel studies, service instruments and replenish consumables, and uphold a safe, compliant, and efficient lab environment.

Knowledge Sharing and Mentorship:

• Share standard methodologies, train junior colleagues on established LC/MS methods, and develop consistent analytical standards across the team.

Essential Skills/Experience:

• BS 7-10 years Industry experience

Solid LC/MS proficiency:

• Proven, hands on experience in protein characterization using multiple mass spectrometry platforms and workflows, with the ability to work independently on routine to moderately complex studies.

Method development and troubleshooting:

• Capability to develop, optimize, and qualify methods; proactively identify issues and lead day to day independent problem solving.

Quality and regulatory understanding:

• Working knowledge of relevant quality systems and regulatory expectations for biotherapeutic characterization, with strong data integrity and documentation practices.

Operational ownership:

• Plan and implement experimental work, manage priorities across parallel tasks, maintain instruments and consumables, and ensure delivery against team commitments.

Mentorship and collaboration:

• Provide guidance to junior colleagues, share standards, and communicate results clearly to cross functional partners through concise reports and presentations.

The duties of this role are generally conducted in a lab environment. As is typical of a lab-based role, employees must be able, with or without an accommodation to: lift/carry 15/30 pounds unassisted/assisted; 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.

Desirable Skills/Experience:

• PhD in Biochemistry, Chemistry or related field and a minimum of 2-5 years related experience.
• Knowledge of charge and size variant analysis.
• Knowledge of additional non-MS methods and instrumentation for testing biotherapeutics.
• Experience with development, optimization, qualification, and validation biotherapeutic assays.
• Experience working with CRO’s for developing assays and testing samples.

When we put unexpected teams in the same room, we ignite 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 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 ambitious world.

Why AstraZeneca:

• Here, science leads and collaboration amplify impact. You will work with inquisitive colleagues who combine innovative analytics with emerging digital and data capabilities to tackle complex disease biology. We bring together industry, biotech, and academic partners to spark ideas that move quickly from question to experiment to decision, always with the patient in mind. We value kindness alongside ambition, encourage bold thinking backed by data, and give you the tools, trust, and support to turn rigorous protein characterization into faster, better medicines for people around the world.

Call to Action:

If you are ready to see your LC/MS expertise shape pivotal program decisions and accelerate medicines that matter, step into this role and help us deliver the next wave of breakthroughs!

Date Posted

Closing Date

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.