Senior Manager, Analytical Development/Quality Control
The Senior Manager, Analytical Development/Quality Control will join the analytical team within Chemistry, Manufacturing, and Controls (CMC) and report to the Associate Director of Analytical Development. This role will work closely with the entire CMC team to execute both early- and late-stage development activities in support of both preclinical and Phase I/II/III clinical activities. Candidates for this position will be required to work independently and have hands-on experience with method development and with managing outsourced analytical and quality control activities at contract manufacturing organizations (CMOs), contract testing labs (CTLs) and contract research organizations (CROs).
- Manage outsourced GLP/GMP studies; interact with CMOs/CTLs/CROs as well as internal teams to ensure timely delivery of analytical data and quality control results.
- Summarize experimental findings, review, and interpret development and stability study results, and assemble analytical data packages to support regulatory submissions.
- Maintain real-time trending of analytical data. Identify trends and any atypical results. Proactively communicate and collaborate with external testing laboratories to investigate out of specification (OOS) results, out of trend (OOT) results and other atypical results. Summarize analytical data for various review activities.
- Leads analytical related investigations.
- Manages method validation/method transfer activities and sample release and stability testing in support of all ongoing development activities.
- Review and approve analytical data, technical protocols/reports, specifications, and analytical methods.
- Develops chromatographic methods and biologics methods (e.g., ELISA, cell-based assays) for APIs and pharmaceutical products.
- Plan and coordinate various studies, including stability evaluation of development compounds and formulations. Provide formulation development support.
- Monitors, organizes, and prioritizes resources to increase efficiency on a regular basis.
- Identifies, implements, and supports efficient approaches in using and improving the systems within CMC.
- BS/BA degree in chemistry or related discipline, advanced degree preferred
- A minimum of 5 years relevant industry experience in the biotech/pharmaceutical industry in an analytical method or quality control role.
- Have extensive knowledge and hands-on experience with analytical instruments including LC, LC-MS, GC, and Dissolution
- Experience with method and specification development for small molecule drug substances
- Experience with method and specification development for solid oral dosage forms and parenteral products
- Familiarity with biologic assays such as ELISA and cell-based methods is a plus
- Ability to operate in alignment with Pliant’s values
- Comprehensive working knowledge of GLPs and GMPs as they relate to drug development and analytical testing
- Solid understanding and knowledge of US and international regulatory requirements related to analytical and quality control testing
- Self-motivation and with high attention to details, ability to analyze, summarize and present data and significant conclusions to key stakeholders and decision makers
- Strong knowledge in phase-appropriate approach for drug development
- Excellent written and verbal communication skills and organizational skills as well as ability to prioritize and manage multiple tasks under tight timelines
- Ability to engage collaboratively with CMC functions, with other functions within Pliant, and with external testing laboratories