Senior Scientist, Product Transfer Specialist

4 weeks ago

San Diego, California, United States Ortho Clinical Diagnostics Full time
The Opportunity

At Ortho Clinical Diagnostics, we are seeking a highly skilled Senior Scientist to join our team as a Product Transfer and Validation Specialist. This role will be responsible for supporting the transfer and validation of molecular diagnostic assays, assay formulations, QC methods, and testing processes into manufacturing.

The Role

This position will be onsite full-time at our facility, where you will work closely with our Research & Development team to address scientific problems and solutions, with Manufacturing to set up and optimize prototype production, with QC staff to optimize downstream testing, and with clinical/regulatory as appropriate.

The Responsibilities

As a Product Transfer and Validation Specialist, you will be responsible for:
  • Supporting the transfer and validation of molecular diagnostic assays, assay formulations, QC methods, and testing processes into manufacturing.
  • Drafting finalized transfer documents containing key manufacturing and QC processes for successful transfer of Molecular Diagnostic Assays to Operations Manufacturing and Operations QC.
  • Developing QC test methods and Gold Stocks for final release of raw materials, sub-assemblies, and final molecular diagnostic products.
  • Participating as an integral member of the scientific staff in formulating research strategy and methodology.
  • Providing recommendations and observations to scientific staff and management on results of projects/tasks.
  • Maintaining records of laboratory activities and notebooks in a professional, accurate manner.
  • Operating complex laboratory equipment, routine maintenance, and coordinating calibration and repairs.
  • Interfacing with contracted repair technicians as required.
  • Understanding theoretical basis for analytical instrumentation.
  • Planning, coordinating, training, and directing the tasks of junior staff assigned to their development projects.
  • Supporting stability studies and quality testing plan for raw materials and/or formulations required for newly developed products, ensuring robust performance.
  • Supporting investigations and studies of current molecular diagnostic products for continuous improvement initiative.
  • Possessing strong technical writing skills to generate verbal and written reports as necessary and to summarize laboratory activities and projects.
  • Contributes scientific leadership and innovation increasingly independent of external direction.
  • Assists in the professional and scientific development of junior staff members.
  • May represent department and/or company to outside organizations and companies, in conjunction with management.
  • Carries out duties in compliance with established business policies.
  • Perform other work-related duties as assigned.
The Individual

We are looking for a highly skilled and experienced Senior Scientist with a strong background in molecular biology, biochemistry, or a related field. The ideal candidate will have a Master's or Ph.D. degree in a relevant field and at least 8 years of related experience. The candidate should have a strong understanding of molecular biology techniques, especially qPCR, and experience with evaluating and transferring injection molded components and other plastics/consumables into a manufacturing environment. The candidate should also have strong quality-orientation, attention to detail, and a desire to deliver service excellence. Additionally, the candidate should have strong influencing and interpersonal skills and the ability to work well with others in a proactive, positive, and constructive manner. The candidate should also have the ability to work cross-functionally on multiple projects, in a fast-paced environment to meet aggressive timelines, with ability to adapt as project roles and timelines require. The candidate should have demonstrated skills in carrying out innovative research with minimal guidance in an accurate, effective manner. The candidate should also have proven ability to functionally direct junior research staff. The candidate should have proven experience generating research hypotheses, analyzing complex problems and data sets. The candidate should also have in-depth knowledge of scientific principals and concepts. The candidate should have strong analytical and problem-solving skills. The candidate should also have excellent organizational skills and ability to manage multiple tasks/projects simultaneously. The candidate should have the ability to plan and execute experiments to prove feasibility, develop new processes and set specifications, characterize materials and set specifications, and troubleshoot problems. The candidate should also have strong technical communication skills, written and verbal. The candidate should have knowledge of relevant analytical tools (Design of Experiments, Statistical Process Control, Problem Solving, etc.). The candidate should also have knowledge of quality system regulations and processes. The candidate should have appropriate computer skills (e-mail, word processing, graphing software, MS Suite). The candidate should understand theoretical basis for analytical instrumentation. The candidate should be knowledgeable of federal and other regulations, e.g. QSR's, ISO, ISO 13485, CMDR. The candidate should demonstrate commitment to the development, implementation and effectiveness of Quidel Quality Management System per ISO, FDA, and other regulatory agencies.

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