Senior Scientist / Manager, Analytical Development

Role Summary

The Senior Scientist / Manager, Analytical Development will be responsible for leading the creation of new analytical methods for biochemical characterization testing of cGMP and developmental product 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 assure effective, efficient, and compliant adherence to all company policies, procedures and when appropriate, cGMP requirements. Also responsible for providing analytical support to Quality Control. This includes, but is not limited to, the following: development of new analytical methods for QC, overseeing transfer of new methods from AD and Research & Development to QC; troubleshooting problems with existing QC methods; characterization of new reference materials, controls, and critical reagents; biochemical characterization testing of cGMP and developmental product manufactured by Celldex Manufacturing Operations; performing screening characterization of early R&D clones to aid in clone selection, as well as drafting Technical Reports for all development, qualification and characterization analyses performed. Oversee the timely assignment and completion of work for the laboratory.

Responsibilities

• Ensure that the following are communicated to management and external departments, when necessary, in a timely, efficient manner (it should be noted that this list is not exhaustive):
• Data / results from method development / qualification including associated technical reports.
• Data / results from method development / qualification including associated technical reports.
• Data gathered in support of lab and / or CAPA investigations.
• Data / results for any testing performed for external CMOs in support of product characterization and / or comparability including associated technical reports.
• Data / results generated for research and development purposes or in support of or collaboration with other departments.
• Review laboratory assays and documentation for accuracy and appropriate timeliness.
• Independently identify and /or manage actual and potential problems as they arise and propose solutions, implement actions to be taken and / or experimental designs to be executed.
• Supervises laboratory investigations in a timely and compliant manner.
• Perform non-routine projects independently, compile accompanying reports and/or data summaries.
• Maintain current awareness of and recommend implementations for improvements in accuracy and efficiency of laboratory functions, procedures and systems.
• Ensure analysts are trained on and proficient in performing new analyses and operating new equipment.
• Oversee and/or conduct various independent laboratory experiments to satisfy the overall AD objectives of development and/or troubleshooting of assays for Quality Control.
• Document all laboratory experiments and tasks in a Celldex issued laboratory notebook in a timely fashion and submit for review.
• Author and/or approve technical reports, qualification reports and transfer study reports based on the results of laboratory experiments.
• Oversee the ordering and receipt of reagents, equipment and lab ware and approve requisitions.
• Present data and discuss progress on ongoing testing and method development at weekly AD team meetings.
• Lead onboarding of new equipment / software / technology brought into the AD / QC lab.
• Propose new ideas for improvement of laboratory methods, procedures and overall departmental responsibilities.

Qualifications

• BS/MS in a science related discipline.
• 8+ years‚Äô experience in Analytical Development preferably in a senior or leadership position in the Biotech/Pharma industry or equivalent combination of education and experience.
• Experience with analytical development of monoclonal antibodies or related biotherapeutic proteins.
• Previous hands on experience with the following analytical techniques:
  • HPLC/UPLC - RP, SEC
  • LC/MS - intact mass, peptide mapping
  • Circular dichroism
  • Capillary electrophoresis - size, charge
• The ability to think and solve problems creatively from a critical and analytical perspective and to teach and guide more junior members of the team.
• Strong interpersonal skills.
• Exceptional self-management skills.
• Excellent written and oral communication skills.
• The ability to work effectively and professionally in both individual and team situations.
• Strong problem solving and organizational skills and the ability to apply concepts.
• Use standard applications software (such as spreadsheets and word processing) for the maintenance of data and production of reports. Experience with advanced automated and AI tools to replace standard applications preferred, but not required

Skills

• Analytical method development
• Mass spectrometry and chromatography
• Laboratory leadership and project management
• Data analysis and technical reporting

Education

• BS/MS in a science related discipline