Labs FSP Senior Scientist: Bioassay & ELISA

at  Thermo Fisher Scientific

JOB DESCRIPTION

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 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 customers to leverage 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.

QUALIFICATIONS:

• PhD (+1 years’ experience in Biopharmaceutical Industry preferred)
• Master’s degree with 2+ years’ or Bachelor’s degree with 4+ years’ experience in Biopharmaceutical industry
• Fields of Discipline: preferably in Cell Biology, Biochemistry and Molecular Biology or similar field of study
• Experience with bioanalytical equipment and software
• Experience in experimental design, method development/troubleshooting
  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, SKILLS, AND ABILITIES:

• Hands-on Experience in plate-based methods. Proficiency in using multi-channel pipettes
• Hands-on experience in mammalian cell culture/aseptic technique, and cell biology techniques
• Hands-on experience in cell-based bioassays
• Ability to work in Biosafety Level 2 environment and follow lab safety procedures
• Highly organized with a keen attention to details
• Ability to work independently, as well as collaboratively
• Excellent communication skills, written and verbal; avility to effectively communicate with supervisor and team members
• Experience with statistical tools and data analysis

KEY RESPONSIBILITIES:

• Execute bioassays (non-cell based and cell-based), immunoassays, and binding assays. Participate in assay development as needed
• Author protocols, technical memos and reports, data analysis summaries, process investigations and procedures
• Daily equipment preparation and calibration
• Support laboratory operation and maintenance (e.g., instrument maintenance, routine lab safety inspection)
• Assist with testing schedule maintenance and coordination

ESSENTIAL FUNCTIONS:

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.