Our well established pharmaceutical client, is looking a seasoned analytical professional, with small molecule experience, who will be responsible for supporting the daily operations of the lab and will help with developing strategies to ensure effective achievement of objectives.
Our client is working on some exciting new projects with new technology, if you are looking to join a highly technical environment where there is always room to grow, this role might be the one for you!
Responsibilites :
- Ensure testing is completed on or before assigned due date
- Communicate material issues or testing delays to the appropriate internal customer(s) (i.e. Manager)
- Critically review raw data, chromatography, data sheets / LIMS, and protocols / reports for accuracy and completeness
- Provides technical support for the evaluation of development, release, and stability data
- Review method validation protocols and reports
- Review analytical procedures
- Review and approve all necessary documentations for IND / ANDA / NDA submissions
- Prepare and / or review responses to FDA deficiency letters
- Demonstrates ability to lead a team of analysts and several projects independently while having a positive impact on personnel and colleagues
- Participates in the selection, development / training and evaluation of direct reports by providing ongoing guidance and support, and write performance reviews and / or evaluations
Qualifications :
- BS Degree in Chemistry or related field - Required
- Minimum of 5 years of pharmaceutical product analysis experience in a cGMP-regulated lab environment
- Experience with writing and editing technical documentation is a must
- Experience writing FDA communications is preferred
- Experience working in the pharmaceutical industry and / or analytical laboratory is a must
- Knowledge of GMP, Industry Guidelines (ICH / FDA) and A / NDA submissions is a must
- Understanding of USP / NF, USP / PF and other compendia documents is a must
- Demonstrated ability to perform method development and validation in accordance with ICH regulations independently
- Good knowledge of Dissolution, Assay, Degradant / Impurities, Residual Solvents and other analytical testing
- Good knowledge of UV / Vis, HPLC, GC and other analytical equipment
Supervisor/ Senior Level Analytical Openings
Our well established pharmaceutical client, is looking a seasoned analytical professional, with small molecule experience, who will be responsible for supporting the daily operations of the lab and will help with developing strategies to ensure effective achievement of objectives. Experience working...
Supervisor/ Senior Level Analytical Openings
Our well established pharmaceutical client, is looking a seasoned analytical professional, with small molecule experience, who will be responsible for supporting the daily operations of the lab and will help with developing strategies to ensure effective achievement of objectives. Experience working...
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