MedImmune, LLC is recruiting for an Associate Director in the Analytical Biotechnology Development department. The successful candidate will lead a team of scientists focused on automation, bioprocess monitoring, and lifecycle management of analytical methods. The team leader will be expected to work closely with customer groups to implement the analytical-method strategy and automated assays to meet the capacity needs necessary to support Quality by Design (QbD) studies.
The candidate will be the global leader for automation of process-monitoring assays within the Biopharmaceutical Development organization and across the enterprise. He or she will guide the development and optimization of fit-for-purpose automated process-monitoring assays utilizing state-of-the-art methods and technology, including assays to monitor drug-product activity and structure (e.g. binding assays, aggregation, etc.), as well as process residuals (e.g. host cell proteins, residual DNA, protein A, etc.). The candidate will be expected to evaluate and implement novel technology and software to enable delivery of rapid results for key decisions during bioprocess development. In addition, the group will develop automated methods to support assay-lifecycle management utilizing Design of Experiments (DoE).
The candidate will be representing the automated process monitoring group on leadership teams and will work closely with senior leaders within the Biopharmaceutical Development organization to set strategic direction, manage budgets, and develop goals. He or she will also represent the department and company at internal and external events and conferences.
This position will require the ability to create strong customer relationships and work in a complex environment. The candidate is expected to identify and lead process improvement and change efforts to optimize the operations and efficiency of the group. He or she will be responsible for the supervision and development of the group staff.
Advanced pharmaceutical-industry experience in assay development and lab automation. Knowledge and practical application of analytical GMP regulations is a must.
BS in Biochemistry, Biology, or related field with at least 10 years' experience, MS with at least 5, or PhD with at least 2 in a related position.
MedImmune, LLC. is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, or any other characteristic protected by federal, state or local law.
MedImmune does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on MedImmune's approved agency list. Unsolicited resumes or candidate information submitted to MedImmune by search/recruiting agencies not already on MedImmune's approved agency list shall become the property of MedImmune and if the candidate is subsequently hired by MedImmune, MedImmune shall not owe any fee to the submitting agency.
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