Method Development Scientist
Proclinical is currently recruiting for a Method Development Scientist with a pharmaceutical company located in Raleigh, NC.
- Responsible for designing and developing new serological binding assays (ELISA, Luminex) for support of vaccine candidate clinical trials.
- Has the ability to work as an independent investigator. Independently plans and executes laboratory research.
- Responsible for the successful qualification or validation of serological assays.
- Able to lead junior scientists in developmental, qualification and/or validation activities.
- Writes, assists, or supervises the writing of protocols and reports, SOPs, forms, and worksheets for new assays, converted assays, updates to existing assays, and transferred assays.
- Scientific responsibility to monitor assays after they are put into clinical testing. Assists in troubleshooting technical problems as needed.
- Work closely with the Clinical Operations, Clinical Sciences and Global functional teams to ensure the translation of the protocol and clinical development plans into executable operational processes.
- Lead internal or external training as required and support the medical monitor in responses to investigators and other site personnel regarding clinical and study conduct questions.
- Independently review study subject level data for presentation to the medical monitor for clinical decision making, throughout the study life cycle. Liaises closely with the clinical safety scientist to support ongoing aggregate safety data review during a given clinical study.
- May manage alone or in collaboration with clinical safety the operational functioning of data monitoring committees and/or clinical adjudication committees. Clinical Scientist may participate in and present at these meetings, as required.
- Participate in analyzing and interpreting data from clinical studies, and writing/editing or reviewing results in study reports, regulatory submissions, abstracts, posters, presentations, peer reviewed manuscripts, and other documents. As required, lead internal data review meetings to determine strategic interpretation.
- May become a member of the company publication group. Additionally, serve as a scientific reviewer for company publications and external research proposals in the area(s) of expertise.
- Participate in the Clinical Operations and Clinical Development teams. Provide support to the clinical development team (CDT) through meeting management support and communication.
- Act as the delegate or lead where required.
- Interact with internal auditing groups on a study level to ensure clinical development activities are conducted according to internal SOPs and work practices and in compliance with ICH-GCP.
Skills and Requirements:
- Bachelor's with at least 5 years' experience in assay development.
- Must have strong background in development of ELISA and/or Luminex assays for the detection and quantification of human antibodies.
- Excellent communication (interpersonal, verbal and written) skills, ability to communicate effectively at all levels.
- Ability to work with global teams
- Knowledge of Health/Safety and Environment good practice.
- Duty to comply with all applicable standards as required by the company
- Experience in GLP laboratory environment.
- Have an understanding, of all routine laboratory procedures.
- Ability to maintain clear and efficient documentation.
If you are having difficulty in applying or if you have any questions, please contact Jarred Fetterman at 215-531-5593.
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.