Scientist II

VITAE ENIM VITAE SCIENTIFIC INC seeks a Scientist II in San Diego, CA.

Duties:

Develop and Validate Analytical method, perform testing of the drug products under highly regulated GMP environment.

The detailed duties are as follows:

• Develop and validate phase appropriate analytical methods for assay, impurity and forced degradation study of the drug substance and the drug product.

• Perform routine testing of raw materials, in-process and finished products and stability samples in support of GMP production.

• Method development and validation for Endotoxin, sterility, and other microbial test methods for the raw materials and final products.

• Validate/verify dissolution method along with profile comparison study as required.

• Perform microbiological tests such as TAMC, TYMC, absence of specified microorganisms, anti-microbial effectiveness testing, sterility, endotoxin, and product specific testing as required.

• Lead investigation and root cause analysis of internal deviations, non-conformance reports and OOS.

• Manage the CAPA process including the review and approval to open new CAPAs as well as approving CAPA plans, timelines, and verification of effectiveness plans to assure timely completion within the established goal, inclusive of Change Control establishment and maintenance.

• Participates in FDA, DEA, and Customer quality system audits.

• Calibrate and troubleshoot the lab equipment such as HPLC, GC-MS, IC, UV, FTIR, TOC, endotoxin, osmometer and particle tester analysis as required.

• Optimizes existing analytical methods to suit their intended purpose with guidance.

• Create or revise specification, SOP, analytical method validation protocol, method validation report, stability summary and report as needed.

• Keep up to date information and document revision for various agency guidelines and requirements such as FDA, USP, ICH, EP, ACS, and CFR.

• Perform environmental monitoring of classified room per ISO guidelines.

• Report testing progress and support to upper management.

• Prepare Audit compliance report and effective implementation of same.

• Support Quality leadership with internal, supplier, regulatory and client audits as the Aseptic Sterility Assurance subject matter expert.

• Develop stability study protocol, execute stability protocol, process data, prepare a summary report, and perform trend analysis.

• Perform cleaning validation and verification as required.

• Qualify non compendial reference standards.

• Perform peer review of data and reports generated by other analysts.

• Follow safety procedures to ensure safety in the lab and make improvements as per OSHA requirements.

• Review data from contract laboratories to ensure accuracy and regulatory compliance.

• Train new hire and other scientists.

Requirements:

• Minimum Master’s degree in Chemistry, Biochemistry, Biotechnology, or a related field.

• 24 months scientific experience in life science/chemistry.

• 12 months experience of handling of new drug substance and drug product that requires special handling and environment.

• Demonstrated knowledge of Analytical Method Validation/Qualification using highly sensitive equipment in GMP environment.

• Demonstrated knowledge of operation and troubleshoot HPLC, FTIR, GC-FID, Ion Chromatography, UV, Particle counter, Endotoxin on specific software.

• Demonstrated knowledge of handling of microbiological materials and testing of the drug products with sound knowledge of USP and FDA guidelines.

• Demonstrated knowledge of handling of highly sensitive air particle counter, and environmental monitoring.

• Demonstrated knowledge of specific skills such as quality events like deviation, CAPA, complaint, out of specification.

• Demonstrated knowledge of handling and documenting respond to the external audit such as FDA, NIH, State FDA, third party etc.

• Demonstrated knowledge of maintaining stability program such as documenting protocol/report and routine testing on time.

• Demonstrated knowledge of handling of controlled substance regulated by DEA.

 

Salary: $102,482 to $105,000/yr

Send CV to charlie@vevscientific.com