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: