Senior Scientist - Client-dedicated (FSP)

Thermofisher Scientific; Ware; On-site; GBP 42,000 - 64,000; Full time

Job summary

Thermo Fisher Scientific is recruiting for a Senior Scientist to support development of drug delivery analyses. You will perform complex sample preparation and quantitative analyses, maintain instrumentation, and train others in GMP/GLP procedures onsite at a pharmaceutical/biopharmaceutical partner, with full-time benefits.

The role requires 3+ years with a Master’s or 5+ years with a Bachelor’s, strong data interpretation, and solid technical writing.

Qualifications

• Bachelor's degree or equivalent in a scientific discipline; relevant vocational qualifications.
• 5+ years of relevant experience or 3+ years with a Master's degree.
• 5+ years of experience with HPLC, KF and Dissolution in a GMP laboratory.
• Experience with Empower software.
• Inhalation testing experience is desirable.
• Oligonucleotide analysis experience is desirable.
• Knowledge of general chemistry and separation science.
• Ability to perform root cause analysis for GMP investigations.
• Ability to review GMP experimental work for data accuracy and compliance.
• Strong technical writing skills.
• Time management and project management skills.
• Good written and oral communication skills.
• Ability to train junior staff.

Responsibilities

• Perform complex sample prep and analysis to quantify pharmaceutical and biopharmaceutical compounds.
• Set up and maintain analytical instrumentation.
• Train on routine operation and regulatory procedures.
• Ensure QA findings are addressed appropriately.
• Troubleshoot instrument or extraction issues.
• Communicate project status to the project leader.
• Adhere to GMP/GLP protocols and reporting requirements.
• Review data for accuracy and compliance before submission.

Skills

Analytical thinking

Scientific writing

Root cause analysis

Problem solving

Communication skills

Team collaboration

Time management

Training junior staff

Education

Bachelor's degree or equivalent

Master's degree with relevant experience

Tools

HPLC

KF

Dissolution

Empower software

Job description

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.

• 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.
  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).
• 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.
  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., 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, 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.