Thermo Fisher Scientific - Collegeville, PA
posted 4 days ago
About the position
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future. 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.
Responsibilities
- Performs a variety of routine to 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.
- Problem solves with assistance pertaining to extraction and/or instrumentation problems.
- Trains on routine operation, maintenance and theory of analytical instrumentation, SOPs and regulatory procedures and guidelines.
- Manages QC/QA responsibilities without supervisor or QA input.
- 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.
Requirements
- 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 to 2-4+ years).
- Master's degree with 1+ years of relevant experience.
- HPLC experience is REQUIRED.
- Dissolution, Karl Fisher, method validation, stability and small molecule experience is preferred.
Nice-to-haves
- 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 Microsoft Excel and Word to perform tasks.
- Ability to independently optimize analytical methods.
- Good written and oral communication skills.
- Time management and project management skills.
- Problem solving and troubleshooting abilities.
- Ability to work in a collaborative work environment with a team.
Benefits
- Competitive remuneration.
- Annual incentive plan bonus.
- Healthcare.
- Range of employee benefits.
- Outstanding career and development prospects.
- Exciting company culture that stands for integrity, intensity, involvement, and innovation.
