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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
The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.
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