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Scientist in Morrisville, NC at Acro Service Corporation

Date Posted: 1/11/2019

Job Snapshot

Job Description

 

Scientist, Morrisville, NC

The Senior Scientist reports to a Manager in the Manufacturing Quality Control group.

This role will lead a team that supports method and product improvements, post approval commitments, and investigations (customer complaints).

The candidate must have the ability to provide direct oversight to a team of 4 - 6 development scientists and lead investigations.

A background in combination products is preferred.

Ability to effectively communicate technical progress to senior internal and external stakeholders both through written and oral communications.

Establish and maintain effective and functional team.

Should possess knowledge of one or number of areas such as analytical methods, formulation, container-closure systems, device design, and manufacturing processes.

Working knowledge of applicable global regulatory requirements desired

Knowledge of FDA requirements (essential), understanding of other regulators (MHRA, EMEA, desirable).

Doctoral degree, master’s degree, or bachelor’s degree in chemistry or closely related physical science from a four-year college/university

PhD and >5 years related experience

MS and >10 years related experience

BS and > 10 years related experience

Years related experience, or equivalent education, experience and training

Experience and prior use of risk analysis tools and their application.

Experience and prior use of statistical analysis tools

Prior experience with regulatory submissions (NDA, ANDA) a plus

Experience with CFR 820 combination products, inhalation products are a plus, but not required.

The Company is an Equal Opportunity Employer (EOE) and offers any job opportunity to any qualified candidate without regard to age, race, gender, national origin, physical appearance, sexual orientation, etc.