Associate Director/Director, Product Development

Website Aucta Pharmaceuticals

Aucta Pharmaceuticals, Inc. - CMOCRO

Aucta Pharmaceuticals, Inc. is a technology-based company focusing on the development and commercialization of Branded Specialty Products. Aucta is a pharmaceutical company creating better products of proven molecules using 505(b)(2) regulatory pathway. Through innovation, Aucta is creating new therapeutics, including new dosage forms, new dosing regimens and new indications.

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, overseeregistration 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 formany 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

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