Senior Scientist / Manager, Analytical Development

Role Summary

The Senior Scientist / Manager, Analytical Development will lead the creation of new analytical methods for biochemical characterization testing of cGMP and developmental products manufactured by Celldex, including advanced techniques such as mass spectrometry and chromatography. Responsible for overseeing equipment maintenance and troubleshooting, as well as laboratory activities to ensure effective, efficient, and compliant adherence to company policies and cGMP where applicable. Provides analytical support to Quality Control, including method development for QC, transfer of methods to QC, troubleshooting, and characterization of reagents and materials. Drafts technical reports for development, qualification and characterization analyses, and oversees timely assignment and completion of laboratory work.

Responsibilities

• Ensure timely communication of data/results from method development/qualification, associated technical reports, CAPA investigations, external CMOs, and R&D collaborations to management and relevant departments.
• Review laboratory assays and documentation for accuracy and timeliness.
• Independently identify and address actual or potential problems, propose solutions, and design experiments.
• Supervise laboratory investigations in a timely and compliant manner.
• Perform non-routine projects independently, compiling reports and data summaries.
• Maintain awareness of and implement improvements in laboratory accuracy and efficiency.
• Ensure analysts are trained on new analyses and equipment.
• Oversee and/or conduct independent laboratory experiments to support development and troubleshooting of QC assays.
• Document all experiments in Celldex laboratory notebooks and submit for review.
• Author/approve technical reports, qualification reports, and transfer study reports based on experiments.
• Oversee ordering/receiving of reagents, equipment, and labware; approve requisitions.
• Present data and progress at weekly AD team meetings.
• Lead onboarding of new equipment/software/technology in the AD/QC lab.
• Propose ideas to improve laboratory methods, procedures, and departmental responsibilities.

Qualifications

• BS/MS in a science-related discipline.
• 8+ years‚Äô experience in Analytical Development, preferably in a senior or leadership role in the Biotech/Pharma industry or equivalent combination of education and experience.
• Experience with analytical development of monoclonal antibodies or related biotherapeutic proteins.
• Hands-on experience with:
  • HPLC/UPLC - RP, SEC
  • LC/MS - intact mass, peptide mapping
  • Circular dichroism
  • Capillary electrophoresis - size, charge
• Creative problem-solving ability and capability to mentor junior team members.
• Strong interpersonal, self-management, written and oral communication skills.
• Ability to work effectively individually and in a team; strong problem-solving and organizational skills.
• Proficiency with standard software for data management and report generation; experience with automated/AI tools preferred but not required.

Skills

• Analytical method development and transfer
• Laboratory leadership and supervision
• Data analysis and technical reporting
• Experiment design and troubleshooting
• Quality systems and cGMP awareness

Education

• BS or MS in a science-related discipline

Additional Requirements

• None specified beyond qualifications