Sr Scientist- Bioanalysis - Thermo Fisher Scientific

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

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 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 demonstrate 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.

Our client's Bioanalysis and Immunogenicity team within the DMPK department is searching for a (Sr) Scientist to join a team developing and running custom ligand-binding assays for research and development purposes. Assay applications will include pharmacokinetic (PK), immunogenicity (ADA) and biomarker (BM) assays in a non-regulated setting as well as oversight of transfer to and execution of assays at regulated labs for studies. This role will be 100% onsite in Cambridge, MA.

Key Responsibilities Include:

• Scientific responsibility for PK and immunogenicity bioanalysis in non-regulated settings
• Design, develop and validate PK, BM and/or ADA assays
• PK, BM and immunogenicity analysis to support in vivo studies
• Transfer assays and monitor bioanalytical studies internally to other global R&D sites or externally to CRO partners
• Report and discuss bioanalytical and biomarker results with integrative knowledge of how the data contributes to the drug development process
• Manage bioanalytical sample inventory, laboratory chemicals, supplies, and ancillary equipment
• Assist purchase order generations

Education & Experience:

• PhD in a life sciences field that includes immunoassay development (e.g. biochemistry, immunology, biology, etc.); or MSc, with 2-4years or BS with 4-6 years of relevant experience.
• Strong background in immunoassay development using technologies such as ELISA, MSD, Gyros, SIMOA, etc.
• Strong knowledge of immunogenicity and principles of bioanalysis: familiarity with current bioanalytical and immunogenicity regulatory guidance (FDA/EMA/ICH) is a plus
• Experience in a regulated bioanalytical laboratory (GLP/GCP/GCLP) is a plus.
• Experience with method development and bioanalytical assays is required.

Additional Key Skills:

• Softmax Pro and/or Watson Lims
• Experience with MSD, Gyros or Quanterix would be a plus!
• Excellent time management, organization skills and communication (verbal, written, interpersonal, listening) skills.
• Ability to work independently with minimal direction.
• Ability to adapt to constantly evolving priorities and multi-task to meet timelines in a fast-paced environment.
• Ability and willingness to work in a laboratory
• Excellent English skills (oral and written)
• Knowledge of MS Office (Word and Excel)

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.

Our 4i Values:

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.

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.