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 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.