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 and clinical 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
Quality-oriented - Prior 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 supervision.
Ability to adapt to rapidly changing priorities and multi-task to meet timelines in a fast-paced environment.
Ability and willingness to work in a laboratory
Team player
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.
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