Analytical Method Validation Chemist

VTI Life Sciences (VTI) is seeking forward-thinking and ambitious engineers looking to accelerate their career in the pharmaceutical, biotechnology and medical device industries. We offer an opportunity to help support our teams of industry subject matter experts and thought leaders while consulting with some of the biggest companies in the Life Sciences industries.

We are looking for Three (3) Chemists for analytical test method transfer/validation to develop protocols and final reports for a variety of analytical test methods at our client's pharmaceutical facility in the Greater Los Angeles area. 

Duties and Responsibilities:

• Generate, review and execute phrase appropriate Method Validation/verification/transfer protocols
• Translate technical information and requirements into experimental design
• Prepare documentation in support of the sampling, analysis, and reporting of Method Validation results
• Perform troubleshooting during Method Validation and transfer
• Perform data analysis, interpretation and review using statistical methods
• Prepare summaries and reports
• Author, compile and track deviations or issues encountered during Analytical Method Validations or transfers
• Write, review and assist in the evaluation of the effectiveness of SOPs and identify necessary changes following validation activities. Ensure that SOPs are current
• Assist in the maintenance of validation/verification/transfer documents
• Assist to write risk analysis (or statistical analysis) as part of validation activities;
• Monitoring and tracking of validation/verification/transfer activities
• Investigate deviations in validation protocols, identify the root cause of the deviation, issue corrective and preventive actions, and carry out follow-up once the actions are implemented to ensure their effectiveness;
• Work closely with QC to ensure accurate scheduling of instrumentation and validation activities
• Work closely with QA to ensure documents are reviewed and approved in a timely manner
• Work closely with Project Management and the Account Manager to ensure that customer expectations with respect to Method Validation and transfers are met
• Perform other duties as assigned

Qualifications:

• BS or MS in Analytical Chemistry or equivalent
• 3+ years experience in a cGMP pharmaceutical/biotechnology laboratory
• Strong technical knowledge KF titrators, HPLC, and protein analysis (Coomassie Stain, Western Blots), etc.
• Strong working knowledge of analytical instruments/software and analytical validation and method transfer principles
• Proficient use of Microsoft Office suite of applications (Outlook, Excel, Word, PowerPoint, Teams, etc.)
• Ability to work as part of a team and also independently with minimal to no supervision
• Ability to rapidly change focus during times of shifting or changing priorities
• Impeccable technical writing skills with extreme attention to detail
• Excellent organizational, multitasking, and communication skills

SALARY RANGE FOR THIS ROLE IS $80,000 - $115,000 ANNUALLY FOR A W2 EMPLOYEE
VTI Life Sciences strives to maintain and inspire professional excellence by providing Commissioning, Qualification, Quality Engineering, Automation and Validation Services to the Pharmaceutical, Biotechnology, Biologics and Medical Device industries. VTI offers professional development, training, competitive compensation, excellent benefits, 401K plus a stimulating and collaborative work environment. We are committed to providing exciting career opportunities in a work environment that values trust, respect, openness, teamwork, creative talent, enthusiasm and diligence.

As one of the leading global Commissioning, Qualification and Validation Services organizations, VTI is always looking for innovative, talented and experienced validation professionals for our multinational and global offices. We offer some of the best salary and benefit packages in the industry for our full-time/permanent employees. www.validation.org

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