Product Transfer Scientist

Posted 15 March 2023
Salary Competitive
LocationUnited States of America
Job type Full Time
Discipline Cell & Gene Therapy
Contact NameAmelia Brown

Job description

Mantell Associates is currently partnered with a leading developer and manufacturer of Bio-Layer Interferometry instrumentation and consumable products, they are on their search for a Product Transfer Scientist to assist in the transfer of newly developed assays from R&D to manufacturing and QC.

Product Transfer Scientists Responsibilities

  • Create formulation documentation, implement quality control procedures, validate reagent formulation including quality control and support of products post launch within the Manufacturing department.

  • Design, Execute, Optimize and Validate biochemical conjugation/assays and QC test methods.

  • Cross functional collaboration with teams to scale technology and troubleshooting for new and existing product.

  • Provide expertise in process engineering, design, and ongoing process improvements to improve process efficiency and robustness.

  • Apply knowledge of biochemistry to develop robust products with streamlined workflows.

  • Plan, design, execute, and report R&D experiments in collaboration with scientists, engineers, data analysts, and biostatisticians to enable bench-based workflow transition to production group.

  • Perform assay characterization to determine critical process parameters and tolerances of the system.

  • Support process development by participating in requirements gathering, process mapping, and risk assessment.

  • Support continuous process improvement activities through change control for implementation in Operations.

Product Transfer Scientists Physical Requirements:

  • To perform this job successfully, an individual must be able to perform each essential duty and responsibility satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Ability to lift, push, pull, carry, and/or move 20 lbs.

  • This role will require long periods of sitting and standing.

  • The employee will be required to use hands for computer work and pipetting.

  • Required biosafety training upon hiring.

  • Must pass a health screening

Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact me on amelia.brown@mantellassociates.com or +44 (0)20 3854 7700.