Website Aucta Pharmaceuticals, Inc.
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.
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. The Analytical Scientist will perform complex analytical testing for various samples including but not limited to in-process, the finished product, stability, raw material, cleaning verification/validation, and development and validation samples. This position is also responsible for participating in laboratory investigations and training other co-workers in the Analytical Lab.
Include but are not limited to:
- Daily set-up, operation, troubleshooting, and maintenance of instrumentation such as HPLC, UV, GC, KF, TOC FTIR, in accordance with written SOPs.
- Provides technical project leadership, participating in protocol development and execution for test method development, validation/verification, and related activities.
- Reviews generated data in a timely manner and elevates any Non-Conformance, Out of Specification, or other Deviation to Laboratory Management in a timely fashion for further investigation.
- Works independently and performs investigative testing or other functions to assist with laboratory investigations.
- Interacts regularly with other departments including R&D, QAS, RA, QA, and Validation to ensure priorities are aligned and projects are on track.
- Performs laboratory testing of Raw materials, In-process, Finished product, and Stability samples for potency and physical characteristics in accordance with company SOP’s as well as cGMP’s.
- 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 following 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 the cross-functional projects, 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.
- Author and review quality and lab operation SOPs. Write technical reports to document analytical methods and maintain laboratory notebooks.
- Other duties as assigned.
- BS/MS/PhD in Chemistry (or relevant discipline) with at least 1 to 3 years of relevant experience in ANDA/NDA pharmaceutical product testing and validation.
- Experience in various analytical techniques and instrumentations (HPLC, UPLC, HPLC-MS, GC, GC-MS, NMR, UV, different types of dissolution units, DSC, etc.) for analytical development.
- Experience in analytical method development, method transfer, verification, and validation to support formulation development and regulatory filings.
- The ability to handle multiple challenges to achieve project timelines and the company’s goals is required.
- Demonstrates technical expertise in instrumental laboratory analysis.
- Prior experience in pharmaceutical (cGMP) laboratory testing is required
- Knowledge of cGMP, USP/NF, EP, current Code of Federal Regulations (21 CFR parts 11, 210, 211, 820) and other FDA regulations and guidance.
If you are interested in this position, please email cover letter and resume to