Process Engineer/Senior Process Engineer, CMC Antibody Production
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 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.
We are currently seeking an experienced antibody production engineer to join our Chemistry, Manufacturing, and Controls (CMC) team at Pliant to play a key role in externalized cell-line development, scale-up, and both non-clinical and clinical manufacture of Pliant’s monoclonal antibody drug candidates. The individual selected for this role will have a high-impact opportunity to establish this new modality into the CMC organization at Pliant. The ideal candidate possesses a strong understanding of cell-line development (CLD), mammalian cell protein expression and protein purification, and formulation with the ability to apply this knowledge in oversight of CLD and antibody production at one or more contract manufacturing and development organizations. The successful candidate will report directly to the Vice President, CMC and will work closely with Pliant’s Biology, Analytical Development, and Drug Product groups to address manufacturability, formulation, and stability issues and optimize the manufacturing process for producing antibodies for both non-clinical and clinical studies and commercialization. The ideal candidate is highly creative, energetic, team focused and thrives in an intellectually rewarding collaborative and science driven environment.
- Identify CDMOs and evaluate their technical capabilities for development and optimization of monoclonal cell lines/mammalian cell protein expression processes and production of antibody drug substance/drug product.
- Provide oversight to CLD, process optimization, antibody production, and drug product formulation activities at CDMOs
- Review master batch records and executed batch records for accuracy and for compliance with technical and regulatory requirements
- Prepare drug substance and drug product development and manufacturing modules for 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.
- Organize and maintain CMC technical information related to antibody manufacturing process development and manufacture
- Provide additional technical support to CDMOs for key decision-making processes.
- Represent the CMC group on antibody project teams to ensure timely communication of any issues potentially impacting timelines, budgets, or development plans.
- Provide phase-appropriate drug product for development activities.
- Contribute to achieving yearly company objectives.
- Provide appropriate updates to senior management.
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.
- BS, MS, or PhD degree in Chemical Engineering, Biochemical Engineering, Molecular Biology, or Biochemistry
- A minimum of 6 years (BS), 4 years (MS), or 2 years (PhD) experience in a process engineering role in support of cell-line development, process optimization, and GMP antibody production with preference to experience with multiple successful IND-enabling activities and supported filings
- Technical expertise in both upstream (CLD and protein expression) and downstream (purification and isolation) operations for antibody development
- Experience with cell culture single-use bioprocessing technologies is essential
- Experience with development and aseptic fill finish of both solution and lyophilized antibody formulations is highly desirable
- Comprehensive working knowledge of CMC regulatory guidelines and cGMP requirements as they relate to manufacture of antibody drug substance and drug product
- Previous experience with CDMO management and vendor oversight is required
- Strong analytical thinking, organizational, and problem-solving skills with a focus on decision-making and results
- Ability to work collaboratively with internal partners in a matrix structure to ensure 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