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Scientist (Large Molecule) - Client Dedicated
2 months ago
We are seeking a highly skilled Scientist to join our Analytical Services team at the client site. As a Scientist, you will play a critical role in supporting the development of innovative drug delivery approaches and providing analytical support for the testing of various samples from GMP and non-GMP studies.
Key Responsibilities- Perform a variety of routine sample preparations and analysis procedures to quantitatively measure large molecule and biopharmaceutical compounds.
- Provide analytical support for the testing of samples from GMP and non-GMP studies for Toxicology assessment, discovery, process research and development.
- Set up analytical instrumentation for analysis using appropriate methods.
- Support the routine operation and occasional maintenance of analytical instrumentation, SOPs and regulatory procedures and guidelines.
- Communicate analytical results to the required team and group leaders in required documentation.
- Problem solving, either independently or with assistance, pertaining to extraction and/or instrumentation problems.
- Provide additional data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP).
- Perform self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers.
- Bachelor Degree in Chemistry, Organic Chemistry, Chemical Engineering, Pharmaceutical Science or similar.
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 2+ years) or equivalent combination of education, training, & experience.
- 1 plus years of experience with HPLC (SEC for antibodies) in a regulated GMP lab is required.
- Knowledge of general chemistry and separation science.
- Experience with HPLC and Empower software.
- Experience in Mass Spec (Glycan analysis of antibodies, Intact mass).
- Immunoassay/bio residual experience useful (quantitative ELISA, SPR,qPCR).
- Ability to support root cause analysis for method investigations.
- Proficiency on technical operating systems.
- Good written and oral communication skills.
- Experience in analytical problem solving and troubleshooting abilities would be advantageous.
- Time management and project management skills.
- Ability to work in a collaborative work environment with a team.
Integrity – Innovation – Intensity – Involvement
If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world's most urgent health needs, submit your application – we'd love to hear from you
