Associate Director/Director, Product Development
Aucta Pharmaceuticals is a new drug product development company. Aucta adopts a branded/generic hybrid model, generating both near term product revenue and mid/long term investment return, it aims to become a significant specialty pharma player in the U.S. and China marketplace integrating R&D, manufacture, and commercialization. We focus on improved dosage form for patients with a therapeutic focus in CNS, Ophthalmic and Inhalation areas.
Essential Duties and Responsibilities
· The individual will be a member of the Product Development team and will report to the VP, R&D.
· He or She will be responsible for the close and effective coordination and tracking of formulation and process development activities under tight program timelines with cross-functional accountability and interdependence.
· Work effectively in a team environment with the internal team including Analytical, Regulatory, Clinical and Quality Assurance etc. in a fast-paced collaborative environment.
· Work independently on formulation and process development and optimization, oversee registration batch manufacturing and validation activities at external contract research and manufacturing organizations (CROs and CMOs).
· The ideal candidate will leverage existing experience to manage formulation activities for many active projects in drug product at all stage of product development, NDAs and ANDAs.
· Develop and scale up formulations and manufacturing processes for solid, topical as well as ophthalmic and/or inhalation formulation with minimal guidance, including pre-formulation, formulation and process development
· Mentor and train junior scientists and lead development projects
· Write up and review protocol, batch records and product development report with high quality
· Be able to show flexibility and ability to work on ad-hoc assignment
Education, Skills, and/or Experience
· Ph.D. in pharmaceutics or other directly related science discipline, Preferably be trained and have 8+ years’ experience in formulation/dose development & process development.
· Familiar with the requirements of the FDA cGMP/GLP regulations, ICH guidelines as well as drug development process.
· Strong communication skills, both written and verbal, and outstanding interpersonal skills are essential job requirements.
· Be able to work in a team-oriented manner in order to accomplish performance objectives.
· Be accountable and demonstrate good working ethics, integrity, ownership and leadership.
· Ability to travel up to 25% of the time