QC Test Method Engineer

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

• Extensive experience performing basic analytical assay techniques such as absorbance assays, chromatography, CE-SDS, ELISA/AlphaLISA, and western blot.
• Extensive experience developing/authoring protocols, methods, and SOPs and performing method qualification/validation activities.
• Strong written and verbal communication skills. (Native or near-native English speaker)
• Ability to work on multiple projects simultaneously, demonstrating organizational and problem-solving skills.
• Self-motivated, proactive and driven individual with an interest in experimental design and development.
• Strong GxP knowledge.
  
  

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

• Master’s degree in biological sciences or related field with 8 years or PhD with 5 years of progressive experience in the biotechnology or pharmaceutical industry.
  
  

Benefits

What We Offer:

• Competitive Compensation: Attractive salary and comprehensive benefits package for full-time and part-time employees, including health, dental, vision, and life insurance, a 401(k) plan with employer match, a generous paid time off policy, and additional perks. Compensation is commensurate with professional experience.
• Career Development: Opportunities for professional growth and advancement within a supportive and innovative environment.
• Work-Life Balance: Flexible work arrangements and a commitment to maintaining a healthy work-life balance.
  
  

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