Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
Job Description
Join Us as an Associate Research Scientist – Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
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.
A day in the life:
Independently performs analytical testing, method optimization/validation, and/or other specialist 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 completes 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 mentorship and training to staff.
Leads analytical (procedural and instrumental) troubleshooting sessions.
Assists in preparation and implementation of SOPs and quality systems.
Reviews, interprets, and analyses data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP). 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
Degree or equivalent in Chemistry or Biochemistry
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.
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
Knowledge, Skills, Abilities
* Knowledge of general chemistry, biochemistry techniques (SDS-PAGE, Western Blot, total protein by BCA or micro BCA assay, ELISA)
* Proven experience of method development of identity and purity assays
* Ideally experience in leading CMC studies for biopharmaceutical products including method validation
* Proficiency on technical operating systems (including Image Lab software)
* Proven problem solving and troubleshooting abilities
* Ability to independently perform root cause analysis for method investigations
* 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
Work Environment
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:
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.
Apply today
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.
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