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Job Description
Primary Responsibilities:
Execution of AR&D’s externalization strategy and optimization of the operating model to deliver results aligned with enterprise goals
Partner with cross functional DCT’s and Bioprocess Research & Development External Capabilities to manage externalized projects
Lead analytical development for all API and drug product deliverables sited at selected external partners including analytical methodqualifications/transfers,technical oversight, and resolution of analytical issues
Lead analytical capability build at selected external partners by identifying focus areas that support our company's current and future pipeline and working closely with internal SMEs to upskill external partners
Partner with internal AR&D stakeholders to author technical protocols, reports, and review technical documents
Ensure high quality documentation from external partners consistent with a compliance mindset
Education Minimum Requirements:
A Ph.D
OR a Master’s degree with a minimum of 2 years of experience
OR a Bachelor’s degree with a minimum of 5 years of experience
Preferred Experience & Skills:
Outstanding communication, critical thinking, and leadership skills
Project management experience including resource management, budget forecasting, and riskassessment/mitigationplanning
Comfort with working in a fast-paced and dynamic environment
Strong knowledge of Biologics CMC landscape including knowledge of GMP, ICH and relevant HA guidelines
Extensive experience with a wide variety of analytical methods, including biochemical, biophysical characterization
Demonstrated track record of working across networks, both internally and externally, to deliver exceptional results aligned with program timelines
Travel (Domestic and/or International) up to 20% of time
Current Contingent Workers apply
*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.
Job Posting End Date:10/01/2024
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
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