Manager/Senior Manager, Analytical Development and Quality Control
Job description
Pliant Therapeutics is a public, clinical 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 disease. The Company's focus is on mechanism-based intervention in the fibrotic process using small molecules.
The Company's lead product candidate, PLN-74809, is an oral, small molecule selective inhibitor of the αvβ1 and αvβ6 integrins that play a key role in multiple fibrotic pathways. PLN-74809 has received Orphan Drug Designation from the U.S. Food and Drug Administration in both idiopathic pulmonary fibrosis (IPF) and primary sclerosing cholangitis (PSC) and are currently in Phase 2a clinical trials for these indications. The company recently reported positive data from its Phase 2a trial in IPF and is currently ramping up activities in preparation for a late-stage clinical trial at worldwide sites.
Pliant has also developed PLN-1474, a small molecule, selective inhibitor of αvß1 for the treatment of nonalcoholic steatohepatitis, or NASH with liver fibrosis. Pliant is initiating 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.
The Company is seeking passionate, creative, and dedicated individuals to join our team and contribute to our mission.
Description
The Manager/Sr. 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 in laboratory and have significant hands-on experience on chromatographic method development.
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 the stability programs for all projects.
- Manage release and stability testing of drug products and drug substances at contract laboratories.
- 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.
- S. in Chemistry or relevant technical field, advanced degree preferred.
- A minimum of 5-7 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 $155,000 - $170,000. 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 https://pliantrx.com/ccpa-applicant-and-staff-privacy-notice/.
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