Scientist, Clinical Immunology Assay Development
Proclinical is currently recruiting for a Scientist of Clinical Immunology Assay Development with a biotechnology company located in Gaithersburg, MD. Successful candidate must have a focus on assay development and validation for viral cell-based assays such as microneutralization assays in GCLP environment.
- Serve as a key person on the scientific team in Clinical Immunology for Influenza, Coronavirus, RSV and any new emerging vaccine programs for assay development and validation.
- Help conduct technical development and qualification/validation of various immunological assays including cell-based viral neutralization assays, HAI, RSV ELISAs or other relevant assays (including experience of mammalian cell culture) required to support various stages of vaccine development, optimization of processes and evaluation of new technologies to improve sample throughout.
- Assay Development (including experimental design and troubleshooting), optimization and validation of immunological assays in support of various stages of vaccine development.
- Provide scientific and managerial capabilities to the assigned project.
- Design, implement, help to execute and oversee study objectives within the assigned project with minimal supervision and lead a team of RAs and provide training as needed.
- Author and review documentation associated with project/objectives including technical reports, operating and work instructions, SOPs, project specific protocols and reports. Possible contributions to scientific publications and presentations (as needed).
- Help to prepare clinical and regulatory agency documents as needed and to participate in the review process of these documents. Provide selected sections for FDA regulatory BLA filing and answering questions.
- Ensure clinical testing performed in their area(s) is compliant with Regulatory, QA and GCLP internal requirements and quality system.
- Investigate and ensure timely closure of Quality events, deviations and maintain CAPA plans.
- Work with automated systems (such as Robotic liquid handling), system integration and software programming.
- Oversight of critical reagent/ equipment qualification/ validation relevant to assay/projects.
- Cost-effective management of assay material and reagent inventories.
- Plan and work independently with minimal supervision under the direction of a Principal Scientist.
- Collaboration with colleagues from Discovery/Preclinical, quality systems (CQA), Clinical Operations Biostatistics, IS/IT and Regulatory Affairs.
Skills and Requirements:
- Scientist I, PhD with 0-2 years relevant post-doctoral experience or MSc with 6 years + of directly relevant or BS with 8 + years in Biology, Immunology, Microbiology, Molecular biology or related field in GCLP Clinical Immunology Lab or other related areas in Biotech or Pharma Industry setting.
- Extensive Experience in Cell based functional viral assays and mammalian cell culture required.
- Must have experience in development, qualification and validation of relevant virological/immunological assays in GCLP environment.
- Experience with management and development of direct reports.
- Understanding of GCLP requirements and other FDA regulatory requirements associated with clinical testing.
- Team player who is well organized with excellent interpersonal and oral/written communication skills and be able to perform multitasking as needed.
- Ability to work effectively with cross-functional groups.
- Ability to work independently on projects with minimal supervision and lead a team of RAs.
- Good Computer skills and experience with relevant software such as Softmax, Excel, PowerPoint, ability to analyze data using statistical tools (e.g. JMP, Prism).
If you are having difficulty in applying or if you have any questions, please contact Max Robinson at (+1) 929-388-1651 or email@example.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.