Analytical Scientist /Chemist
Company: Aucta Pharmaceuticals, Inc.
Posted on: November 25, 2022
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
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
*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
* 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
* Perform scientific tasks and activities related to analytical
development including support of formulation development, stability
studies, method development, method validation, troubleshooting and
* 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
* Author and review quality and lab operation SOPs. Write technical
reports to document analytical methods and maintain laboratory
* 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 of analytical method development, method transfer,
verification and validation to support formulation development and
* Ability to handle multiple challenges to achieve project
timelines and company's goals is required.
* Demonstrates technical expertise in instrumental laboratory
* Prior experience in a pharmaceutical (cGMP) laboratory testing is
* 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
* 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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