Analytical 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 Products, 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.

Position Summary

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.

Required Education/Experience

• Prefer BS/MS/PhD in Chemistry (or relevant discipline) with 1 to 3 years of relevant experience in ANDA/NDA pharmaceutical product development.

Please apply using the below function and send your CV/Resume directly. Please mention that you saw this JD on the SAPA website.

Upload your CV/resume or any other relevant file. Max. file size: 128 MB.