Senior Scientist, Product Transfer Specialist

1 week 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.

  • Certified Nursing Assistant

    3 weeks ago

    San Diego, California, United States Senior Living Recruiting Specialist Full time

    Join Our Team as a Certified Nursing Assistant!We are seeking compassionate and dedicated Certified Nursing Assistants (CNAs) to join our team at Senior Living Recruiting Specialist. As a CNA, you will play a vital role in providing high-quality care to our residents, ensuring their physical, emotional, and social needs are met.Responsibilities:Provide...

  • Transfer Specialist

    1 month ago

    San Diego, California, United States Service Corporation International Full time

    Job Title: Transfer SpecialistAt Service Corporation International, we celebrate lives and honor our associates. We're seeking a skilled Transfer Specialist to join our team.Job Summary:The Transfer Specialist is responsible for the safe and respectful transportation of deceased individuals. This role requires collaboration with other team members to ensure...

  • Senior Environmental Scientist

    2 months ago

    San Diego, California, United States Department of Parks & Recreation Full time

    Job SummaryThe Department of Parks & Recreation is seeking a highly skilled Senior Environmental Scientist - Specialist to join our team. As a key member of our Resources Program, you will work under the general direction of the Senior Environmental Scientist (Supervisory) to coordinate legislatively mandated resource management plans and compliance.Key...

  • Senior Scientist, Drug Product Analytics

    4 weeks ago

    San Carlos, California, United States BioSpace, Inc. Full time

    Job SummaryVaxcyte is seeking a highly skilled and experienced Senior Scientist to join our Drug Product Analytics team. As a key member of our team, you will be responsible for leading analytical method development and execution for Drug Product characterization, as well as managing a team of scientists to support process development activities, formulation...

  • Senior Data Scientist Product

    2 weeks ago

    San Diego, California, United States Google Full time

    About the RoleWe're seeking a highly skilled Data Scientist to join our team at Google. As a Data Scientist, you will play a critical role in helping us understand our users and develop data-driven solutions to drive business growth.As a member of our team, you will work closely with cross-functional partners to design and implement data-driven solutions...

  • Product Review Specialist

    4 days ago

    San Diego, California, United States Product Review Jobs Full time

    Product Review Specialist OpportunityAt Product Review Jobs, we are seeking a Product Review Specialist to participate in market research opportunities with independent brands. As a Product Review Specialist, you will be responsible for completing online or phone studies to provide valuable feedback on various products.Key Responsibilities:Complete online or...

  • Certified Nursing Assistant

    1 week ago

    San Diego, California, United States Senior Living Recruiting Specialist Full time

    As a Certified Nursing Assistant with Senior Living Recruiting Specialist, you will play a vital role in providing compassionate care to our residents. Our senior living community relies on dedicated professionals like you to ensure the well-being of our residents.We offer a stable and long-term career with opportunities for growth and development. Our CNA's...

  • Senior Bioprocess Scientist

    4 weeks ago

    San Diego, California, United States Simply Biotech Full time

    Senior Bioprocess Scientist Job DescriptionSimply Biotech is seeking a highly skilled Senior Bioprocess Scientist to join our team in San Diego, CA. As a key member of our Bioprocess Development team, you will be responsible for developing and optimizing media and processes to support seafood cell culture.Key Responsibilities:Develop strategic approaches to...

  • Senior Scientist, Drug Product Process Science Specialist

    1 week ago

    South San Francisco, California, United States Allogene Therapeutics Full time

    Allogene Therapeutics is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR TTM) products for cancer and autoimmune disease.The company is seeking a highly motivated individual for the role of Senior Scientist, Drug Product Process Science to join the Process and Product Development...

  • Transfer Specialist

    3 weeks ago

    San Diego, California, United States SCI Shared Resources, LLC Full time

    Job Title: Transfer SpecialistAt SCI Shared Resources, LLC, we celebrate lives and our associates. We're seeking a skilled Transfer Specialist to join our team.Job SummaryThe Transfer Specialist is responsible for the safe and respectful transfer of deceased individuals. This role requires collaboration with other team members to ensure compliance with local...

  • Senior Environmental Scientist Specialist

    1 month ago

    San Bernardino, California, United States Department of Fish and Wildlife Full time

    Job Title: Senior Environmental Scientist SpecialistThe Department of Fish and Wildlife is seeking a highly motivated and experienced Senior Environmental Scientist Specialist to join our team. As a key member of our Habitat Conservation Cannabis Unit, you will play a critical role in implementing the Lake and Streambed Alteration program (LSA) and reviewing...

  • Senior Data Scientist, Minerva

    5 days ago

    San Diego, California, United States Amazon Full time

    About the RoleAs a Senior Data Scientist at Amazon, you will be part of the Minerva team, a cross-functional science, analytics, and ML org of highly experienced scientists, BI/data engineers, and software engineers. We build science-based systems for marketing and content-discovery for indie authors, fraud/abuse, and content risk for our publishing...

  • Senior AI Data Scientist

    4 days ago

    San Diego, California, United States Faro Health Inc. Full time

    About the RoleFaro Health Inc. is seeking a highly skilled Senior AI Data Scientist to join our team. As a key member of our data science team, you will be responsible for developing and implementing AI-powered solutions to improve clinical trial design and outcomes.As a Senior AI Data Scientist, you will work closely with our CTO to shape the AI strategy...

  • Senior Environmental Scientist

    3 weeks ago

    San Diego, California, United States Department of Parks & Recreation Full time

    Job Title: Senior Environmental ScientistJoin the Department of Parks & Recreation as a Senior Environmental Scientist and play a key role in protecting and preserving California's natural resources.Job Summary:The Senior Environmental Scientist will work under the general direction of the Senior Environmental Scientist (Supervisory) and will be responsible...

  • Senior Environmental Scientist Specialist

    2 weeks ago

    San Luis Obispo, California, United States Department of Transportation Full time

    Job Title: Senior Environmental Scientist SpecialistJob Summary:The Department of Transportation is seeking a highly skilled Senior Environmental Scientist Specialist to join our team. As a key member of our environmental team, you will be responsible for leading advanced mitigation projects within Caltrans' HQ's Advanced Mitigation Program. You will work...

  • Senior Principal Scientist

    4 days ago

    San Diego, California, United States Pfizer Full time

    Pfizer's Oncology Research Unit (ORU) in La Jolla, California, is seeking a Senior Principal Scientist (PhD) to join the Tumor Immunity team focused on delivering breakthroughs that change patients' lives by redirecting the immune system against cancer.The Senior Principal Scientist will be responsible for driving scientific strategies and their...

  • Senior Environmental Scientist

    1 week ago

    San Diego, California, United States Department of Parks & Recreation Full time

    Job Description and DutiesThe Department of Parks & Recreation is seeking a highly skilled Senior Environmental Scientist to join our team. As a key member of our Resources Program, you will work under the general direction of the Senior Environmental Scientist (Supervisory) to coordinate legislatively mandated resource management plans and...

  • Senior Scientist, Assay Development Specialist

    2 weeks ago

    San Bernardino, California, United States Allen Spolden Full time

    Job Title: Principal Scientist, Assay DevelopmentA highly skilled and experienced Principal Scientist is sought to join our team at Allen Spolden, where you will play a key role in developing innovative NGS-based assays from concept to commercialization. As a senior member of our team, you will be responsible for directing, mentoring, and contributing to...

  • Transfer Specialist

    1 month ago

    San Jose, California, United States Service Corporation International Full time

    Job Title: Transfer SpecialistAt Service Corporation International, we celebrate lives and honor our associates. We're seeking a skilled Transfer Specialist to join our team.Job Summary:The Transfer Specialist is responsible for the safe and respectful transportation of deceased individuals. This role requires collaboration with other team members to ensure...

  • Senior Bioanalytical Scientist

    2 weeks ago

    San Diego, California, United States Tr1X Full time

    Job OpportunityTr1X, a biotechnology company, is seeking a highly skilled Senior Scientist to join its Bioanalytical Sciences team. The successful candidate will be responsible for developing and optimizing analytical methods, including assays and characterization methods, to support the company's cell therapy portfolio.The ideal candidate will have a strong...