Sr. Scientist 8/24/2016
Lab Support, A Division Of On Assignment
San Diego, CA
JOB DESCRIPTIONAPPLY Our client, a leading pharmaceutical firm, is seeking a Sr. Scientist to join their rapidly expanding team.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
This position is responsible for performing all assigned and routine document related tasks in accordance with SOPs and relevant regulatory requirements to include Good Laboratory Practice (GLP) and Good Manufacturing Practices (GMP).
Responsible for setting up a new Pharmaceutical Quality/CMC testing laboratory to be run following GMP guidelines
Drive the effort to identify, purchase, install and qualify all necessary lab equipment under GMP
Write Bioanalytical Procedures and SOPs
Responsible for ensuring that GLP/GMP guidelines for development and validation of assays and sample analysis are meticulously followed.
Assist Principal Investigator in developing and validating cell-based analytical assays to meet final requirements of QAU review and release.
Review of validation and analytical data. Write and review final validation reports and QC raw data that go to the reports.
Schedule analysts, supervise QC preparation, reagent tracking, and order necessary reagents.
Keep accurate inventory of supplies for laboratory operations, including cell lines banking.
Responsible for accurate record keeping with regards to sponsor s samples, data and reports.
Responsible for general lab safety with regard to employees and clients.
Contribute technical and scientific expertise to developing and validating new assays.
Interact with Principal Investigator on all new and on-going projects; supervise the development and validation activities in the laboratory.
PhD in Science or Engineering preferred but not required
It is absolutely essential for the candidate to have gained extensive experience in performing GMP equipment/software qualification in order to be considered for this role
Minimum 3-5 years industry work experience, including at least 2 years of GMP experience
Expertise in Molecular Biology/Biochemistry methods with at least some cell-based assays experience (analytical characterization, qPCR, DNA/mRNA analysis, FACS, cell line engineering, cell-based bioassays, etc.)
Excellent technical writing skills, including SOP writing