The posting
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Laboratory Setting
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 clients to make the world healthier, safer, and cleaner.
Within our Analytical Services team, we have a functional service provider solution, which is an outstanding partnership that allows our customers to use 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:
This role will be supporting the development of innovative drug delivery approaches, and feedback/observations from the analytical work will be sought to guide future work. A person with an innate scientific curiosity and keen observation skills will have the opportunity to impact the future medicine development.
Essential Functions:
- Performs a variety of complex sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds in a variety of formulations and /or biological matrices for stability and analytical testing.
- Sets up and maintains analytical instrumentation.
- Trains on routine operation, maintenance and theory of analytical instrumentation, SOPs and regulatory procedures and guidelines.
- Ensures QA findings are addressed appropriately.
- Problem solving, either independently or with assistance pertaining to extraction and/or instrumentation problems.
- Communicates project status to project leader.
- Performs work assignments accurately, and in a timely and safe manner.
- 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 5+ years) or equivalent combination of education, training, & experience.
OR
- Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 3+ years).
Knowledge, Skills and Abilities:
- 3 plus years of experience with HPLC, KF, Dissolution, in a regulated GMP lab is required.
- Experience with Empower software.
- Experience in inhalation testing is desirable.
- Experience in oligonucleotide analysis desirable.
- Knowledge of general chemistry and separation science.
- Ability to independently perform root cause analysis for GMP method investigations.
- Ability to review GMP experimental work, ensuring data accuracy, completeness, scientific validity and full compliance with GMP standards.
- 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.
Why Join Us:
We hire the best, develop ourselves and each other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore you will benefit from an award-winning learning and development programme, ensuring you reach your potential.
What we offer:
As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD® clinical research services truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. 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.
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!
