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