Akebia Therapeutics is seeking a highly motivated individual to join its Technical Services team as an Associate Director, Formulation Development. The successful candidate will report to the Senior Director, Technical Services and be an integral part of the development and manufacturing team. The position will focus drug product manufacture, including development, validation, and data review.
- Develop stable and bioavailable formulations for clinical and commercial use.
- Generate data for project progression and regulatory filings, conduct optimization and process scale up studies.
- Perform basic statistical analysis of experimental data.
- Hands on oversite of the manufacturing process at the Akebia CMOs with a focus on process improvements and resolution of critical manufacturing issues.
- Provide technical support for drug product development and tech transfer, and process validation activities.
- Interact within cross functional project teams including drug substance, Quality assurance, and CMC teams.
- Provides any necessary support to site manager as required.
- PhD. with 10+ years of experience in pharmaceutical sciences, material science, or related discipline.
- MS with 12+ years of experience in pharmaceutical sciences, material science or related discipline.
- Must be willing to travel to DP manufacturing site for on-site support.
- Experience with formulation development, GMP drug product manufacturing, validation, release testing, and characterization.
- Direct experience working with CMOs.
- Experience working with small molecule new chemical entities (NCEs).
- Experience with a range of dosage forms.
- Must be well-organized and self-motivated, and possess an independent work style.
- Excellent interpersonal skills with the ability to interact professionally and effectively with peers, management, and contract organizations.