Teva Associate Director Drug Product Development 

United States, Pennsylvania, East Bradford Township 

754527250

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

• 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

Minimum Qualifications

• Bachelor’s in chemistry, biology, pharmaceutical sciences, biochemistry, chemical engineering or other related discipline with 15 years of experience in biologics development, or Master’s in a related discipline with 10 years’ experience, or Ph.D. in a similar discipline with 7 years of experience.
• Understanding with hands on experience of biological drug product development, including formulation and manufacturing process development.
• Experience in leading manufacturing process tech transfer is required.
• At least 3 years of people management experience.
• Minimum 3 years of experience working in a matrix team to progress biologic products.
• Experience authoring and reviewing regulatory submissions related to CMC activities.
• Current knowledge of regulatory guidelines related to biologic pharmaceutical development, characterization, and comparability including ICH guidance and cGMP.
• Experience working in a matrix team to progress biologic products.

Preferred Qualifications

• Ability to develop plans and deliver results in a dynamic changing environment.
• Highly motivated individual, with ability to work in a team environment and build productive relationships within and across departments.
• Excellent project management, verbal/written communication, and interpersonal skills.

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