Scientist - HPLC, GMP

Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission – to enable our customers to make the world healthier, safer, and cleaner.

Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to leverage the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.

As an Associate Research Scientist you will be responsible for the regulatory and scientific conduct of development, validation, stability projects, and/or other specialty technologies such as extractable/leachable studies.  

Summarized Purpose:
Responsible for the regulatory and scientific conduct of development, validation, stability projects, and/or other specialty technologies such as extractable/leachable studies. Performs troubleshooting on multiple analytical instrumentation (HPLC, GC, UPLC, ICP-MS, LC/MS, GC/MS etc.) and multiple detection techniques (UV, FL, CAD, ELSD, IC etc.), calculates and interprets data, and records data in adherence with PPD SOPs and any additional requirements specific to the lab and / or client. Routinely acts as the technical project leader for multiple projects, interacts with clients on a weekly basis (or as needed) to provide updates, reviews and evaluates data, writes reports and protocols.

Essential Functions:

• Independently performs analytical testing, method optimization/validation, and/or other specialty technologies studies OR method transfers for 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 executes experiments independently.
• Reviews and critiques study protocols, project status reports, final study reports and other project-related technical documents.
• Prepares and reviews study protocols, project status reports, final study reports and other project-related technical documents.
• Communicates data and technical issues to clients on a weekly basis (or as needed).
• Provides technical guidance and training to staff.
• Leads analytical (procedural and instrumental) troubleshooting sessions.
• Assists in preparation and implementation of SOPs and quality systems.
• 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:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years).

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:  

• Knowledge of general chemistry and separation science
• Experience with HPLC, Dissolution testing, Empower, GMP environment
• Ability to independently perform root cause analysis for method investigations
• Proficiency on technical operating systems
• Proven problem solving and troubleshooting abilities
• Proven ability in technical writing skills
• Time management and project management skills
• Good written and oral communication skills
• Ability to work in a collaborative work environment with a team
• Ability to train junior staff

Working 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.

As a condition of employment with Thermo-Fisher, in this role, you must have received your Covid-19 vaccine and you must disclose proof of your vaccination status upon employment. 
 

#LI-LM2

Salary : $40 - $0