Job Description

Work Schedule

Environmental Conditions

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. At PPD, part of Thermo Fisher Scientific, we hire the best, develop ourselves and each other, and recognize the power of being one team. It's not just talk; our award-winning training programs speak for themselves.

Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to demonstrate 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.

Summarized Purpose: 
Performs laboratory analysis of pharmaceutical drug product formulations and drug delivery devices in development using low field “benchtop” NMR instrumentation and another analytical techniques to characterize drug product suspension physicochemical properties including particle size, particle settling behavior, particle-excipient interactions, wettability, surface area and porosity, and other solid-liquid interfacial phenomena. Works with team to design and execute experiments and sample analysis. Proficiently uses analytical instrumentation, calculates and analyzes data, and records data in adherence with SOP's and the industry. Balances delivery on multiple projects, interacts with clients, reviews and evaluates data, writes reports and protocols.

Essential Functions:  

Independently performs assigned analytical testing of pharmaceutical samples and drug product delivery devices.

Understands and conforms to methods and protocols applicable to assigned tasks.

Familiarity with or ability to learn new analytical techniques to flexibly meet the analytical needs of the department—this may include conducting suspension resuspendability experiments, support for accelerated stability studies, and exploring orthogonal techniques complementary to LF-NMR.

Communicates data and technical issues to the client and responds to client needs and questions.

Coordinates laboratory activities with other team members and assists in troubleshooting instruments and analytical problems.

Assists with quality systems and new equipment.

Reviews, interprets, and analyzes data for technical, quality and compliance to protocols, methods, SOPs, and client criteria. Performs self and peer review of the data for accuracy and compliance with reporting requirements.

Education and Experience:  

• At minimum, a bachelor’s in chemistry, chemical engineering, material science, or other related discipline or equivalent with 6+ prior experience in materials properties characterization, specifically rheology. or MS and 4-6 years of experience in the above specified areas.
• A PhD with min of 2+ years of experience in the above related areas
  

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:   

• Prefer familiarity with NMR spectroscopy, including sample preparation, basic data acquisition, and rudimentary operating principles especially in applications of materials science and physical properties.
• Some experience working in a GMP/GLP environment is preferred, but not required
• Ability to understand and follow laboratory requirements, PPD & client SOPs, ICH guidelines, USP requirements and FDA guidance as appropriate
• Ability to utilize Microsoft Excel and Word to perform tasks
• Proven problem solving and troubleshooting abilities
• Effective oral and written communication skills
• Demonstrated ability in technical writing skills
• Time management and customer management skills
• Ability to work in a collaborative work environment with a team

Working Environment:

PPD, part of Thermo Fisher Scientific values the health and well-being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• 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
  

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

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