QC Test Method Engineer

Job Description

Job Description

ELIQUENT Life Sciences is the leading global consulting firm providing solutions to life science companies researching, developing, and manufacturing innovative products to serve patients and respond to public health challenges around the world. ELIQUENT is committed to serving clients’ needs with extensive expertise, unwavering integrity, and strategic insight in a manner that supports availability of safe, effective, and high-quality drugs, biologics, and medical devices. For more information, please visit our website at eliquent.com

We are seeking a Scientist to contribute to our growing Analytical Development team. The Scientist will be responsible for all aspects of method development, qualification, and execution. This position requires hands-on laboratory experience working with analytical techniques for testing of drug substance and drug product to provide phase appropriate analytical development in support of clinical programs to commercial registration and post approval improvements.

This is an on-site, technical laboratory-based position that involves development, validation, and execution of analytical methods for testing. The ideal candidate will be expected to work collaboratively and cross-functionally with Process Development, R&D, Formulation Development, QC, and other technical groups by providing analytical testing support.

ESSENTIAL DUTIES and RESPONSIBILITIES :

• Execute technical analytical methodologies to support development and validation of test methods.
• Author and review analytical methods, protocols, reports, and other technical documents, including instrument qualification and change control.
• Operate and maintain (as well as overseeing the installation of) sophisticated analytical instrumentation and associated computer control systems.
• Be part of a team that establishes, maintains, and improves technical operations and project outcomes in the Analytical Development area.
• Provide support for laboratory operations – inventory tracking, reagent preparation, sample management, and documentation review.
• Execute analytical and biological methods ensuring compliance with applicable ICH guidelines and global regulations.
• Ensure adherence to GMPs, GLPs, GCPs and GDPs where required.

QUALIFICATION REQUIREMENTS :

STRONG PREFERENCE WILL BE GIVEN TO :

Expert level understanding in drafting protocols, methods, and / or procedures.

Expert level understanding in method qualification and validation.

Experience or working knowledge in neurotoxin as therapeutics.

Experience in performing change control, deviation, laboratory investigation, and / or other quality records.

Education :

Benefits : What We Offer :

Eliquent Life Sciences is proud to be an Equal Opportunity Employer, committed to employee diversity.