Associate Director, Late Stage Formulation Sciences - BPD

Gaithersburg, Maryland

Posted in Pharmaceuticals
about 1 month ago

This job has expired.

Job Description

Leadership position for late-stage formulation development of biologics responsible for project decisions and deliverables, scientific and organizational objectives, and people development of direct reports. Lead development of intended commercial Drug Products to advance late-stage portfolio. Lead Drug Product design approaches and strategy, with a focus on patient-centric/end-user Drug Product design. Review marketing applications and support regulatory responses to approval. Interface with stakeholders to ensure seamless end-to-end product development. Drive scientific initiatives and innovation through personal leadership. Design and implement scientific and business strategies integrated across biopharmaceutical development.

Position Requirements:

In-depth knowledge of formulation and biopharmaceutical development of biologics, protein biochemistry and degradation mechanisms, biopharmaceutical manufacturing processes, and/or combination drug products is required. Hands-on development experience related to design of commercial Drug Product configurations, primary packaging systems, patient/end-user advocacy, in-use environments and hospital pharmacies, human factors studies, and CMC regulatory marketing applications is critical. Knowledge with PK/PD, dose setting, microbial control for sterile products, and/or commercialization of antibody-drug conjugates and/or novel biologic modalities are a definite plus.

Education Requirements:

B.S. in chemistry, biochemistry, pharmaceutical sciences, engineering, applied sciences, or related field with 15+ years of experience, M.S. with 12+ years, or Ph.D. with 7+ years.

Skills and Abilities:

Demonstrates strong scientific knowledge and thinking to navigate projects and the business forward. Effectively and efficiently explains and presents complex scientific concepts to diverse audiences. Develops creative solutions to complex problems, but likewise proficient at anticipating and heading off potential issues. Displays ability to resolve conflicts through effective interpersonal communications and cross-functional collaborations, effectively managing multiple stakeholders. Has vision and values imbedded in collaboration and inclusion. Establishes significant value and sphere of influence on internal and external-facing teams. Influences long-term organizational goals and direction. Demonstrates ability to lead teams effectively and create development opportunities for scientists. Excels at making good decisions and priority setting, while managing complex projects on tight timelines with high degree of self-motivation and drive for results.

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