Responsibilities: Prepare drug listings and lot distribution reports for biologics. Compile documentation and send certificate of pharmaceutical product requests to the FDA Manage notarizations and legalization/apostille of regulatory d...
: Bachelor's degree in engineering, LifeSciences, Quality Management, or related fields. 2-5 years of experience in quality...
Engineering or Sciences disciplines. 8+years of experience in process validation (IQ/OQ/PQ) within a regulated industry...
, Pharmaceutical Sciences) with 3+(BS) or 1+years (MS), biopharmaceutical industry experience preferred. Hands...
's degree in engineering, LifeSciences, or a related field. Proven experience in commissioning and qualification in the...
Responsibilities: Perform routine analytical testing to support quality control testing of pharmaceutical products. Some data interpretation required. Coordinate testing of samples and input data into computer applications. Should have ...
Responsibilities: Review computerized systems validation documents such as: Requirements Specification, Design Specification, CSV Risk Assessment, Test Plans, Test Summary Reports, Data Migration Plan, Pre/Post Executed Test Scripts, Trac...
Responsibilities: A minimum of eight (8) years of process/plant engineering experience in GMP MFG large molecule biologics facilities. Experience in green or brown field GMP MFG facility start-up including process systems, automation, ut...
Responsibilities: Perform in vitro primary cell culture using human PBMCs, Cyno PBMCs, and mouse splenocytes. Conduct serial dilutions of drug molecules and apply treatments using a multichannel pipette. Perform Live/Dead and antibody s...
required for his position. Degree in Mechanical, Industrial Engineering or Sciences disciplines. 8+years of experience in process...