Senior Manager, Analytical Development and Quality Control
3 weeks ago
Pliant Therapeutics is a late-stage biopharmaceutical company focused on the discovery and development of novel therapies for fibrotic diseases. Founded by Third Rock Ventures with world-renowned academic thought leaders, Pliant is raising the bar to meet the unmet medical needs of physicians, patients and families impacted by fibrotic diseases. As the leader in the discovery and development of novel therapeutics for the treatment of fibrotic diseases, Pliant is developing small molecule drug candidates specifically designed to impact the fibrotic process.
The Company's lead product candidate, bexotegrast (PLN-74809), is an oral small molecule, selective inhibitor of the αvβ1 and αvβ6 integrins that play a key role in multiple fibrotic pathways. Bexotegrast has received Fast Track Designation and Orphan Drug Designation from the U.S. Food and Drug Administration for both idiopathic pulmonary fibrosis (IPF) and primary sclerosing cholangitis (PSC) and Orphan Drug Designation from the European Medicines Agency in IPF and PSC. Pliant is currently conducting BEACON-IPF, a Phase 2b/3 trial of bexotegrast for the treatment of IPF.
Pliant is conducting a Phase 1 study for its third clinical program, PLN-101095, a small molecule, dual-selective inhibitor of αvß8 and αvß1 integrins, that is being developed for the treatment of solid tumors. The Company also has discovery and development programs in oncology and muscular dystrophies.
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.
To understand how Pliant complies with and manages your personal information with respect to the California Consumer Privacy Act, please visit
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