Description

The Associate Director, Formulation Development will conduct/lead pre-formulation, formulation development, tech transfer, scale-up, and manufacturing activities at Pliant and it's CMO partners. This role provides scientific expertise in solid oral dosage formulation development, late-stage process development, oversight of GMP drug product manufacturing at contract development sites, authoring global regulatory filings (INDs, IMPDs, etc.) and technical oversight of preclinical formulation development. Reporting to Senior Director, Formulation Development, this position will collaborate with cross functional departments and other CMC functions in a fast-paced high growth environment team to ensure progression of Pliant small molecules from discovery through development/commercialization.

Responsibilities

• Design and execute development and characterization studies to evaluate formulations, primary container closure systems, and drug product manufacturing unit operations.
• Work closely with the Pliant team to develop and evaluate formulation and process development related activities at both in-house Pliant labs and at CMOs.
• Develop strategies and execute plans for drug product development from first time in human formulations through development of NDA ready formulations in accordance with timelines and requirements of overall development programs.
• Screen and help identify drug product manufacturing CMOs for Pliant programs.
• Lead formulation and process development, technology transfer, scale-up, and clinical manufacturing activities at CMO sites.
• Review and approve manufacturing documents, protocols, and reports.
• Support manufacturing and quality in problem solving production issues and deviation investigations.
• Design and execute statistical design of experiments (DoE) studies to evaluate formulations and process prior to transfer and during scaled production at CMOs.
• Design, develop and execute late-stage process development and optimization activities to identity CPPs, CQAs etc. leading into commercial process validation.
• Write technical reports and author CMC sections of regulatory submissions related to drug product from IND through NDA stage of development.
• Be self-motivated and organized and familiar with the relevant literature.

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.

• Ph.D. / M.S in Pharmaceutical Science or related field.
• 8 years’ experience in pre-formulation and formulation development for small molecules, preferably solid dosage forms, 5 years in managing outsourced development activities.
• Experience in formulation and process development for late phase development; preferably with direct experience with late-stage oral solid dose manufacturing process.
• Good working knowledge of GMP requirements for drug product development and manufacturing.
• Good understanding of ICH, FDA, EMA guidance’s in CMC and Quality areas.
• Effective written and oral communication and interpersonal skills.
• Experience in leading formulation projects in pre-formulation, formulation development, and process selection and scale up, and oversight of GMP manufacturing of drug products.
• Excel in team settings with ability to think critically and work independently.
• This position may require up to 10 - 25% travel time (highly variable).

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 $200,000 - $210,000. 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.