Intern to Scientist

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.

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. The Analytical Scientist will perform complex analytical testing for various samples including but not limited to in-process, finished product, stability, raw material, and packaging material. This position is also responsible for participating in laboratory investigations in the Analytical Laboratory.

• Perform basic wet chemistry test for Raw materials and Packaging components in accordance with analytical method/specification, USP/NF, and manufacturers.
• Document into Analytical laboratory notebook and Analytical release report according to Good Documentation practices (GDP) guidelines. Strong knowledge of ICH and cGMP guidelines.
• Daily set-up and operation of instrumentation such as HPLC, GC, KF, FTIR, in accordance with written SOPs.
• Reviews generated data in a timely manner and elevated any Non-Conformance, Out of Specification, Lab event 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, 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.
• Ensure all analytical testing activities are following applicable compendia, cGMP, FDA, ICH, and DEA guidelines/regulations.
• Carry out routine tasks, routine housekeeping related to the laboratory, and maintenance of analytical equipment usage logbooks.
• Proposes changes for continuous improvement, either in safety, GMPs, or general Analytical Laboratory efficiency. Communicate with management concerning all Healthy and Safety issues.
• Other duties as assigned.

BS in Chemistry (or relevant discipline) freshly graduate or 1 year of relevant experience in ANDA/NDA pharmaceutical product testing and validation.

Working knowledge of analytical laboratory theory and techniques and familiarity with GMP procedures required for the laboratory work.

Familiar with operations of laboratory equipment, Balances, pH meter, Karl Fischer, FTIR, HPLC and potable instrument.

Capable of analysis and reasoning. Sense of ownership and pride in work. Critical, detailed and organized. Self‑motivated, collaborative and team player.

Strong attention to detail and ability to follow written procedures.