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Analytical Scientist /Chemist

Company: Aucta Pharmaceuticals, Inc.
Location: Piscataway
Posted on: November 25, 2022

Job Description:

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, 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.

*Duties & Responsibilities*

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 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.
* Author and review quality and lab operation SOPs. Write technical reports to document analytical methods and maintain laboratory notebooks.
* Other duties as assigned.

*Required Education/Experience*

* 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 of analytical method development, method transfer, verification and validation to support formulation development and regulatory filings.
* Ability to handle multiple challenges to achieve project timelines and company's goals is required.
* Demonstrates technical expertise in instrumental laboratory analysis.
* Prior experience in a 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's.

Job Type: Full-time

* 401(k)
* Dental insurance
* Health insurance
* Life insurance
* Paid time off
* Retirement plan
* Vision insurance
* 8 hour shift
Supplemental pay types:
* Bonus pay

Ability to commute/relocate:
* Piscataway, NJ 08854: Reliably commute or planning to relocate before starting work (Required)

* CGMP: 1 year (Required)

Work Location: One location%58047475%

Keywords: Aucta Pharmaceuticals, Inc., Trenton , Analytical Scientist /Chemist, Other , Piscataway, New Jersey

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