The opportunity
Teva’s Global Research & Development (R&D) organization is devoted to the development of new medicines, devices and combination products that provide meaningful therapeutic benefit to patients worldwide. Combining creativity, scientific rigor and our extensive knowledge on a broad range of technologies, our scientists, engineers, medical doctors and project leaders across the globe use their expertise to innovate novel biologics, biosimilars, small molecule specialty medicines, generics and over-the-counter therapies.
Located in West Chester, PA, Biologics CMC is a division of Teva Pharmaceuticals responsible for the development of biologics. The rapidly growing staff of Biologics CMC specializes in the development of innovative biologics, biosimilars, and extended half-life bio-betters. We currently are developing products in various stages of clinical development from IND through BLA filing. Drug Product Development (DPD) is a function within Biologics CMC dedicated to development of formulation, drug product manufacturing process, and process tech transfer to GMP manufacturing sites.
Associate Director is a key leadership role in DPD reporting into the head of the department and managing a team of scientists with project leadership responsibilities. The Associate Director is responsible for drug product development for Teva biologics products to ensure project deliverables are met.
This position is located out of West Chester, PA and the person hired for this role will be required to be onsite 5 days a week
How you’ll spend your day
Responsible for biologics drug product development including manufacturing process tech transfer to support PPQ and commercial manufacturing.
Represent DPD on matrix teams to progress the pipeline including interfacing with regulatory and nonclinical and clinical organization to develop appropriate regulatory submissions and respond to agency questions.
Collaborate with the Combination Products Group for the development of devices (i.e. PFS, NSD, AI) providing knowledge of the characteristics of the drug product and providing expertise to any collaborative study design for products delivered via devices.
Contribute to relevant Drug Product sections in regulatory submission and response to address regulatory questions.
Contribute to resource planning, objective setting and any other business-related processes as appropriate.
Provide leadership in cross department initiatives.
Manage scientists of various experiences. Including providing opportunities for development, as well as advising, coaching and mentoring.
Represent DPD as it relates to external technical collaborations
