Formulation Scientist

Website Aucta Pharmaceuticals

Aucta Pharmaceuticals, Inc. - CMOCRO

Aucta Pharmaceuticals, Inc. is a technology-based company focusing on the development and commercialization of Branded Specialty Product, 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 support the development and testing of drug products under the guidance of senior staff. He or She will be responsible for the close and effective coordination and tracking of formulation activities under tight program timelines with cross-functional accountability and interdependence. The ideal candidate will leverage existing experience to manage formulation activities for many active projects from early to late stage of drug product development.

  • Develop and scale up formulations and manufacturing processes for complex dosage forms with minimal guidance, including pre-formulation, formulation, and process development
  • Familiar or capable of independent operation of commonly used equipment in formulation development lab
  • To 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

Experience and Skills Desired

  • MS with 1 years of experience or PhD with 0-1 years of experience in pharmaceutical industry or other directly related science discipline, preferably be trained in formulation/dose development & process development of pharmaceutical drug products
  • Strong scientific background and working knowledge of conducting pharmaceutical pre- formulation, formulation, and process development studies of various complex dosage forms
  • Experience in ophthalmic drug product development preferred
  • Experience in manufacturing process unit operations, scale-up, technology transfer, and in-

    process control testing.

  • Familiar with the requirements of the FDA cGMP/GLP regulations, ICH guidelines and

    experience in FDA ANDA regulatory submission.

  • Strong communication skills, both written and verbal, and outstanding interpersonal skills are

    essential job requirements.

  • Be able to work in a team-oriented manner to accomplish performance objectives.
  • Be accountable and demonstrate good working ethics, integrity, ownership, and leadership.

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