Scientist will oversee regulated bioanalytical PK, ADA, Biomarker assay development & execution in support of nonclinical safety & clinical studies.
27th July, 2020
Bioanalytical Scientist needed for perm/direct hire - San Diego
Position Description: Our client is seeking an innovative, highly motivated, experienced, resourceful, hands-on individual to join our expanding Preclinical team in the role of Senior Scientist, Bioanalytical. The Scientist will oversee regulated bioanalytical PK, ADA, and Biomarker assay development and execution in support of nonclinical safety and clinical studies. The successful candidate must have scientific knowledge and technical experience in developing, troubleshooting, transferring, optimizing, and validating PK, ADA, and Biomarker assays for biotherapeutics in biological matrices. Candidate must be able to design and oversee the execution of bioanalytical method development and validation studies using accepted industry methods with minimal guidance and supervision. The qualified candidate will be knowledgeable of current FDA and EMA GLP/GCP compliance as it relates to bioanalytical PK and ADA methods. The candidate is expected to manage outsourced bioanalytical projects and CROs to ensure high quality Bioanalytical data/reports are delivered in accordance with project timelines.
PhD in a relevant scientific discipline with at least 5+ years’ experience in bioanalytical assay development is a must.
Experience in the design, implementation, and management of PK ADA, and Biomarker assay development in accordance with current industry standards for drug candidates in support of clinical stage programs.
Experience in identifying and selecting high quality CROs for the conduct of clinical bioanalytical work.
Able to successfully transfer and oversee qualification and validation of bioanalytical methods at CROs and oversee the subsequent analysis of clinical samples.
Able to review and interpret bioanalytical data/reports in support of nonclinical safety studies and clinical trials.
Effectively communicate with other departments within the organization, senior management, development teams, and CROs.
Provide project summaries/reports in project team meetings.
Experience in preparation of BA sections for regulatory (IND or foreign equivalent) filings is a plus.
Excellent written and verbal communication skills, and ability to write technical reports.
Excellent organizational skills, attention to detail and the ability to work independently and within a multi-disciplinary environment as well as with external vendors.
Ability to prioritize and work in a fast-paced and diverse environment is required.
Strong sense of urgency, initiative, ethics, integrity, and innovation is required