Associate Director, Drug Product Development

Who we are

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

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

Your experience and qualifications

 

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 communica