Job Description

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 Scientist, you will use state-of-the-art technologies to perform traditional and innovative analytical techniques and Quality-by-Design principles to develop and validate the analytical tools used to ensure the safety, efficacy, and quality of the customer pharmaceutical products. As a member of the Analytical Development team, you will provide project support to the drug development programs at the customer site through laboratory techniques commonly used in the analysis of pharmaceuticals such as HPLC,UPLC and Dissolution

Additional key responsibilities for the role on site at a major pharmaceutical company:

• Develops, troubleshoots and conducts dissolution experiments in support of drug product process development
• Performs dissolution stability testing on drug products
• Maintains accurate records of experiments and results in an electronic laboratory notebook and authors reports as assigned in compliance with applicable SOPs and guidelines
• Designs, executes, and interprets experiments with a high degree of reliability and independence
• Performs basic statistical analysis of experimental data, where appropriate
• Maintains general lab equipment, including HPLCs and dissolution systems.
• Demonstrates knowledge of scientific principles and basic understanding of applicable drug development regulations
• Performs other duties as assigned

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.

Join PPD, part of Thermo Fisher Scientific in our relentless pursuit of excellence - apply now!

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Education and Experience:

• A Bachelor's degree degree in Chemistry, Biochemistry, Chemical Engineering or Pharmaceutical Chemistry and 0-2 years relevant analytical experience
• Knowledge of HPLC and dissolution testing is required
• Excellent experimental documentation is required

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.

Preferred Qualifications:

• A basic knowledge of cGMPs (desired but not required)
• Dissolution experience across multiple systems (manual, semi-automated and automated dissolution systems)
• Experience with biorelevant dissolution testing
• The ability to work successfully in both a team/matrix environment as well as independently
• The ability to work in a fast pace environment, manage priorities, and maintain timelines for multiple projects
• Self-motivated, organized and detail oriented

Knowledge, Skills and Abilities:

• Knowledge of applicable regulatory authority, compendia and ICH guidelines
• Ability to understand and independently apply GMPs and /or GLPs to everyday work with regard to documentation and instrument use
• Ability to utilize ELN, Empower is a plus, and Microsoft Excel and Word to perform tasks
• Ability to independently optimize/analyze analytical methods
• Good written and oral communication skills
• Time management and project management skills in a fast paced environment
• Problem solving and troubleshooting abilities
• 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.
• As a condition of employment with PPD, in this role, you must have received your Covid-19 vaccine and you must disclose proof of your vaccination status upon employment.

Our 4i Values:

Integrity - Innovation - Intensity - Involvement

If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, submit your application - we’d love to hear from you!