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.
The Analytical Scientist will provide analytical support for various pharmaceutical dosage forms (such as oral solids, suspension, topical, and ophthalmic). This position will also co-ordinate with other functional groups to achieve the company’s goals.
Duties & Responsibilities
Include but are not limited to:
· Perform scientific tasks and activities related to analytical development including support of formulation development, stability studies, method development, method validation, troubleshooting and method transfer.
· Ensure all analytical testing activities are in compliance with applicable compendia, cGMP, FDA, ICH, and DEA guidelines/regulations.
· Work closely and effectively with CROs and CMOs to manage outsourced analytical development work in a timely manner.
· Collaborate with cross-functional project teams to meet the product development milestones and regulatory filing timeline.
· Author or review CMC sections related to analytical methods and method validation, specifications, and stability in NDAs, ANDA and other regulatory submissions.
· Conduct investigations for out-of-specification (OOS) and out-of-trend (OOT) testing results according to relevant SOPs. Ensure data integrity and timely completion of investigation/CAPAs.
· Review analytical data for completeness and correctness.
· Author and review quality and lab operation SOPs.
· Other duties as assigned.
· Prefer BS/MS/PhD in Chemistry (or relevant discipline) with 1 to 3 years of relevant experience in ANDA/NDA pharmaceutical product development.