Senior Manager, Analytical Development and Quality Control

Description

The Senior Manager, Analytical Development and Quality Control will join the analytical team within Chemistry, Manufacturing, and Controls (CMC). 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 clinical phase I/II/III activities. Candidates for this position will be required to work independently and have significant hands-on experience on chromatographic method development.

This is a hybrid position, requiring 3 days/week at Pliant (South San Francisco).

Responsibilities

• Manage the development, qualification/validation, and transfer of analytical methods at contract laboratories. Review analytical data from contract partners, provide feedback and facilitate resolution of technical or quality issues.
• Manage CMOs/CROs testing labs for all analytical development and quality control activities
• Assist in selection and management of contract laboratories.
• Collaborate with other members of CMC team to ensure timely release of clinical products and resolution of product investigations.
• Author and review technical reports, deviations, and change control documents.
• Summarize experimental findings, review, and interpret development and stability study results, and assemble analytical data packages to support regulatory submissions.
• Manage sample inventory and support miscellaneous activities, such as shipping etc.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, abilities, and prior experience required.

• B.S. in Chemistry or relevant technical field, advanced degree preferred.
• A minimum of 8 years’ experience in analytical development of new chemical entities in the pharmaceutical industry including managing methods development, validation, and testing at contract testing laboratories.
• Must have hands-on experience with analytical development techniques used in pharmaceutical industry including LC, LC-MS, GC, and Dissolution.
• Comprehensive working knowledge of GLPs and GMPs as they relate to drug development and analytical testing.
• 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.

Pliant requires all new hires to be fully vaccinated prior to the first date of employment (subject to any legally required exemptions).

The annual base salary for this role is $160K – $170K. Individual pay may vary based on additional factors, including, and without limitation job-related skills, experience, work location and relevant education or training. Pliant’s compensation package also includes benefits, equity, and annual target bonus for fulltime positions.