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.
****Job Type: Intern to Full-time****
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.
Duties & Responsibilities
Include but are not limited to:
- 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.
Required Education/Experience
- 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.
