This position is responsible for the review and approval of all analytical data to support drug substance and drug product manufacturing, testing, stability and release.
- Able to troubleshoot, zero in and identify areas of opportunity for improvement of analytical methods.
- Ensure that analyses of experimental and stability samples are coordinated and conducted strictly in accordance with cGMPs, company's SOPs, methods and protocols.
- Ensure that all laboratory documentation is completed to the highest quality standards and that any formal investigations e.g. Out of -Specification (00S), Changes or Deviations in Data, are conducted promptly and thoroughly.
- Develop, author, implement and revise all company QC SOPs.
- Convey results of analytical studies and participate in project discussions within development teams.
- Keep up to date with technical advances in analytical and pharmaceutical sciences.
- Stay abreast of current trends in regulatory requirements in the field of CMC, QA, and QC.
- Responsible for preparation and/or review of the analytical chemistry portion of the CMC section of a drug product submission.
- Knowledge of Pre-formulation studies in order to provide data on APIs that will lead to development of suitable pharmaceutical products.
- Review analytical methods, validation protocols, reports, and method transfer protocols.
- Review and approve stability protocols for drug substance and drug product.
- Review and approve stability tables for drug substance and drug product.
- Review release and stability specifications for drug substance and drug product. Propose and revise specifications as necessary.
- Review and approve all analytical data to support drug substance and drug product manufacturing, testing, stability and release.
- Minimum B.S. in a science related to Pharmaceutical Analysis
- Minimum of 5 years, preferably 8-12 years of pharmaceutical analytical development experience in the pharmaceutical industry
- Good understanding of analytical method validation requirements of pharmaceutical industry for developmental compounds as well as commercial products.
- Good understanding of the chemistry of pharmaceutical APIs and of analytical techniques for their characterization
- An understanding of microbiological testing requirements for drug substance and drug product.
- Candidates must have a good theoretical knowledge and practical experience of chromatographic sciences and spectroscopic technologies e.g. UV, IR, MS, NMR, XRPD
- Analytical data review skills across multiple software platforms
- Capable of managing multiple projects
- Conduct analytical section audits as part of overall CMO/CRO audit
- Candidate should be able to trend data, perform statistical analysis, etc.
- Very positive interests in keeping up to date with new technologies and developments in analytical sciences
- Good understanding of cGMP, ICH, FDA, and EU requirements
- Comfortable working in a "virtual" environment