Job Abstract

Work Schedule

Environmental Conditions

Job Description

In labs and health care facilities worldwide - HERE WE ARE

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 employees to gain direct experience working onsite at a client pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits with us.

Location/Division Specific Information:

This role is an Assoc Research Scientist position, fully onsite at our client's GMP lab location in Summit, NJ. This is a Monday-Friday, 1st shift position.

Responsible for the regulatory and scientific conduct of development, validation, stability projects, 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 and provides updates, reviews and evaluates data, writes reports and protocols.

• 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 implements experiments independently.

• 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

• AND 6+ years of previous experience that provides the knowledge, skills, and abilities to perform the job

• 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 of general chemistry and separation science

• Ability to independently perform root cause analysis for method investigations

• Proficiency on technical operating systems

• Proven problem solving and troubleshooting abilities

• Consistent record 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 others

Thermo Fisher Scientific values the health and wellbeing 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 while prioritizing and handling multiple projects or activities.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.