Associate Research Scientist

Description

• Independently performs method validations, method transfers and analytical testing of pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or delivery systems. Understands and conforms to methods and protocols applicable to assigned tasks. Designs and drives experiments with minimal supervision.
• Prepares study protocols, project status reports, final study reports and other project-related technical documents.
• Communicates data and technical issues to the client and responds to client needs and questions.
• Mentors, trains and coordinates laboratory activities of other team members and assists in troubleshooting instrument and analytical problems.
• Assists with quality systems and new equipment.
• Assists in designing method validation or method transfer protocols and establish project timelines.
• Reviews, interprets, and analyzes data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Clinical Practices (GCP) or Good Laboratory Practices (GLP). Performs self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers.

Qualifications

• Bachelor degree required. Relevant formal academic / vocational qualification. Technical positions may require a certificate.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (4-5 years of experience).
• Solid understanding and knowledge of general chemistry and separation science
• Full understanding of laboratory requirements, PPD & client SOPs, ICH guidelines, USP requirements and FDA guidance
• Ability to apply Microsoft Excel and Word to perform tasks
• Proficiency on technical operating systems
• Proven problem solving and troubleshooting abilities
• Effective oral and written communication skills
• Proven ability in technical writing skills
• Time management and project management skills
• Ability to work in a collaborative work environment with a team
• Proven problem solving and troubleshooting abilities