Teva Sr Scientist Humoral Immunogenicity 

United States, Pennsylvania, East Bradford Township 

402008065

In this role you will lead a team of 3 analysts tasked with the design, development, troubleshooting, and execution of the assays to support immunogenicity evaluation in pre-clinical and clinical studies. You will also serve as a representative and subject matter expert on project teams for Teva Biologics programs liaising with internal and external groups on project status. As a member of the Specialty Bioanalytics department, you will also be responsible for writing study plans, study reports, BLA/IND submission documents, and SOPs.

Key Responsibilities:

• Directly manages a team of 3 analysts and cultivates that team within a matrixed environment
• Design and develop novel ligand binding assays for evaluation of anti-drug antibodies and incorporate improvements into existing processes
• Provide clear and concise written and oral presentations to internal and external stakeholders, including reports supporting regulatory submissions
• Rises to the challenges of a dynamic development landscape through exemplary leadership and application of strategic versatility
• Minimum expectations of 4 days on site (West Chester, PA)

Required Qualifications:
• BS + 7 years’ experience designing, developing, and validating bioanalytical assays.OR
• MS + 5 years’ experience designing, developing, and validating bioanalytical assays.
OR
• PhD + 3 years’ experience designing, developing, and validating bioanalytical assays.
• Degree work focused in Immunology, Biology, Biochemistry, or related discipline
• Extensive experience (3-10 years) designing, developing, and validating bioanalytical assays (such as anti-drug antibody, neutralizing antibody, and/or PK assays) in pharma, biotech, or CRO
• Previous experience working in a regulated environment (GLP and/or GCLP), including SOP and report writing, deviations and laboratory investigations, and participating in audits
• Experience with SpectraMax plate readers and MesoScale Discovery instruments
• Routine experience with LIMS (e.g. Watson) and ELN (e.g. NuGenesis) are essential for this position
• Track record of excellent written and verbal communications and interpersonal skills
• Able to work collaboratively in a multi-cultural, fast-paced, matrixed environment with ability to handle multiple tasks, set priorities, and meet study timelines

Preferred Experiences:
• Previous successful experience with managing direct reports is highly desired

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