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Associate Scientist

Newark Metro Area, NJ

Posted: 11/12/2018 Job Type: Scientific Job Number: JN -112018-23026
Analytical Development is a science-driven organization dedicated to building in-depth and comprehensive knowledge of our products and their processes through well-designed analytical studies. We work in all phases of pharmaceutical development to oversee the analytical processes for drug substance and drug product development both internally and with external contract service providers. Our goal is to enable the establishment of specifications and robust analytical procedures that allow control of our drug substance and drug product processes to provide safe, efficacious and high quality products to the patients we serve.

The Associate Scientist will develop, validate, and implement analytical methods to assess physical and chemical properties of pharmaceutical materials. This work is conducted in a highly-collaborative, multi-disciplinary team charged with the overall research & development of our active ingredients, formulated products, and the associated manufacturing processes. The Associate Scientist plays an important but supporting role throughout the development of new drug candidates from discovery to commercialization, contributing to the advancement of new therapeutics.

Responsibilities for an Associate Scientist include, but are not limited to, the following:

Contributes to the development of priority drug candidates through the development, validation, and
implementation of analytical methods involving modern analytical instrumentation including HPLC/UPLC, GC, dissolution, FT-IR, Karl Fischer titrations, etc.

Transfers validated methods to customer labs, partner-owned quality control (QC) labs.
Performs testing for development and clinical materials and stability samples in accordance with established methods, specifications and protocols under supervision.
Knows the fundamentals of analytical methodology and can troubleshoot instrumentation and method performance issues of routine complexity.
Documents / reviews laboratory work using laboratory notebooks / worksheets that is detailed, timely and in compliance with GLP / GMP requirements.
Contributes data to the preparation of high-quality technical reports as source documents for regulatory submissions.
Reviews data for compliance and adherence to specifications and acceptance criteria.
Communicates results according to project timelines and works with collaborators to understand project needs and contribute to overall analytical control strategy. Draws basic conclusions from data and results.

Complies with Environmental Health and Safety Requirements
Other duties as assigned by supervisor.

Skills Required:
Familiar with HPLC, dissolution, FT-IR, UV/VIS spectrophotometry, titrations, etc.
Experience in laboratory investigation and documentation of Out-of-Specification results.
Experience in the development and performance of analytical tests for a variety of drug substances and products (including solid oral dosage forms and injectables) is a plus.

Expectations of an Associate Scientist Include:
Strong verbal and written communication skills, and interpersonal skills as a team player.
Willing to work in an environment where individual initiative, accountability to the team, and professional integrity are required. This position will have direct impact on department sub-team or project team performance.
Familiar with cGMP/GLP guidelines, ICH, FDA, and EMA guidelines.
Familiar with USP and other compendia.
Recognizes analytical test problems, can investigate problems and take appropriate steps to resolve and communicate issues. Recognizes technological limitations and addresses them usually under guidance of lab manager/direct supervisor.
Exhibits sound scientific judgment based on reasonable assumptions and available information.
Demonstrated ability to conduct and document analytical laboratory experiments under minimal

- BS/MS Chemistry (or relevant discipline). Ph.Ds will not be considered for this role Minimum 3 years cGMP / GLP pharmaceutical laboratory experience.
- Hands-on experience with separations techniques (HPLC, UPLC, GC, etc.)
- Completed BS and 4-6 years; MS minimum of 3 years in Chemistry (or relevant discipline) with pharmaceutical experience.
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