Manager/Senior Manager, Drug Substance Manufacturing

Manager/Senior Manager, Drug Substance Manufacturing

 

Pliant Therapeutics is a 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 for progress to meet unmet medical needs for patients and physicians. 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 designed to be a selective inhibitor of 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), has completed Phase 1b testing. Pliant’s second product candidate, PLN-1474, is designed to be an oral, small molecule selective inhibitor of αvβ1, targeting late-stage liver fibrosis and is partnered with Novartis. The Company is seeking passionate, creative, and dedicated individuals to join our team and contribute to our mission.

Description

We are currently seeking an exceptional synthetic organic chemist to join our process chemistry team within Chemistry, Manufacturing, and Controls (CMC) and take a key role in route scouting, process optimization, impurity synthesis, analytical marker synthesis, and development of robust and efficient drug substance manufacturing processes. The ideal candidate possesses a strong understanding of modern organic chemistry and a broad synthetic organic background with the ability to apply this knowledge in a practical setting. A strong track record of peer-reviewed publications and research presentations is a plus. He/she will be responsible for executing in-house process chemistry efforts at Pliant Therapeutics as well as providing oversight and technical support for process development and GMP manufacturing efforts of drug substances at contract development and manufacturing organizations (CDMOs). He/she will also work closely with R&D Chemistry and Analytical Development to design and develop more efficient synthetic routes to help API manufacturing for all programs at Pliant Therapeutics. The ideal candidate is highly creative, energetic, team focused and thrives in an intellectually rewarding collaborative and science driven environment.

Essential Functions

  • Evaluate technical capabilities of CDMOs for the manufacture of starting materials, intermediates, and/or drug substances, negotiate contracts, and outline project timelines.
  • Oversee process chemistry development and manufacturing activities at Pliant CDMOs to ensure timely delivery of a quality product.  Follow up on project related actions between the CDMOs and Pliant. Review, track, and archive technical documents from CDMOs.
  • Review or prepare process chemistry technical reports.
  • Review master batch records and executed batch records for accuracy and for compliance with technical and regulatory requirements
  • Prepare drug substance modules of global regulatory submissions.  Review related modules from other functional groups.
  • Provide subject matter expertise to Quality Assurance led cGMP audits and investigations.  Track and review relevant documentation to support and ensure implementation of corrective actions.
  • Provide synthetic routes for contract facilities.
  • Perform laboratory work as needed to support on-going process development.
  • Provide additional technical support to CDMOs for key decision-making processes.
  • Represent drug substance on project teams to ensure timely communication of any issues potentially impacting timelines, budgets, or development plans.
  • Provide phase-appropriate drug substance for development activities.
  • Decipher complex manufacturing process challenges and provide technical assistance to CDMOs.
  • Contribute to achieving yearly company objectives.
  • Provide appropriate updates to senior management.
  • Flexibility to support multiple development groups within Pliant beyond manufacturing.

 

Requirements

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, and/or abilities required.

Education/Experience and Qualifications:

  • BS, MS, or PhD degree in Chemistry with a concentration in organic chemistry
  • A minimum of 10 years (BS), 7 years (MS), or 3 years (PhD) experience in a chemistry role including several years in process chemistry
  • Comprehensive working knowledge of CMC regulatory guidelines and cGMP requirements as they relate to drug substance manufacturing
  • Previous experience with CDMO management and vendor oversight is required

Knowledge, Skills and Abilities:

  • Strong analytical thinking and problem-solving skills with a focus on results
  • Ability to work collaboratively in a matrix structure while ensuring that timelines and deliverables are met
  • Excellent verbal, written, and interpersonal communication skills with the ability to influence individuals and teams across the organization to a desired outcome in the absence of a formal reporting relationship
  • Ability to work independently with minimal guidance
  • Ability to build and manage relationships with external business partners
  • Accuracy and attention to detail
  • Ability to grasp new technologies and to apply existing technologies to new problems
  • Ability to work under tight deadlines and to effectively prioritize and manage multiple projects (multi-task) with rapidly shifting priorities in a very fast-paced environment