FSP-Associate Research Scientist-Characterization

As an Associate Research Scientist, you will perform complex laboratory analysis of pharmaceutical products and proficiently use analytical instrumentation, calculate and analyze data and record data in adherence with PPD SOP's and the industry. You will routinely act as the project leader on multiple projects, interact with clients, review and evaluate data, write reports and protocols. You will be responsible for the scientific conduct of the project and communication of regulatory issues with senior level team members.

What You'll Do

• 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 Manufacturing Practices (GMP) 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.

Education and Experience Requirements

ARS: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 6+ years') OR Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 4+ years') OR PhD and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 2+ years').

Knowledge, Skills, Abilities

• 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
• Ability to train junior staff

Work Environment

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary and/or standing for typical working hours.
• Able to lift and move objects up to 25 pounds.
• Able to work in non-traditional work environments.
• Able to use and learn standard office equipment and technology with proficiency.
• May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.