(Archived) Principal/ CMC Technical Development Leader

Description

The Pharmaceutical Development US team in North Brunswick NJ has a long track record of developing successful Animal Health pharmaceutical products including Frontline® Plus, NexGard®, NexGard® Combo and NexGard® Plus. We are actively working on developing the next generation of products and looking for experienced pharmaceutical scientist with passion for project management to lead our Pharmaceutical Technical development team (Chemistry Manufacturing & Control (CMC) Technical Development Team).

People and culture are the drivers of success, and this engine is fueled by the intention to build enriching careers on the way as we deliver novel drugs to help protect and treat disease in pets, horses and livestock.

We prevent disease. We champion innovation. We cherish the deep connection that people and animals share.

Description:
The Principal/CMC Technical Development Leader (TDL) is the project leader responsible for fast and efficient technical Development projects resulting in the creation of a robust product and complete CMC technical package to ensure successful global regulatory approvals by relevant health authorities and scale-up and industrialization of the finished product.

The Principal TDL or TDL must work globally and cross-functionally to drive the development of new product development projects from development to launch as the leader of Technical Development Teams.

We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

Duties & Responsibilities

• The Principal/CMC TDL must work globally and cross-functionally to drive the development of new product development projects from development to launch as the leader of Technical Development Teams.
• Drive the identification of strategic risks related to the technical development plan, regularly conduct risk assessments, and ensures development of mitigation strategies and contingency options.
• The position requires mobilizing personnel, interfacing and acting as a bridge between product development and commercial manufacturing, while ensuring the transferring of technically complex data in a manner that is understood and accepted by the receiving manufacturing site to ensure development of robust pharmaceutical product.
• Prepare and present information related to the technical development aspects, at internal governance meetings and external health authority meetings

Requirements

• Position requires significant experience in Animal or Human Health product development.
• Technical understanding of process development and good technical problem-solving skills.
• Understanding of relevant health regulatory agency requirements for new drug product submissions, ideally animal health related experience.

CMC Technical Development Leader:

• M.S. in Science with 5+ years or B.S. in Science with 7+ years of Animal or Human Health product development experience.
• At least 5 years experience in pharmaceutical drug development
• The position requires expertise in the development of finished products including a high-level understanding of the regulatory, quality and clinical requirements.
• Involvement in more than one product developments which resulted in successful products on the market and/or multiple patents filed.
• Exceptional organization skills assuring timely delivery of results supporting multiple projects in parallel.
• Functional representative in multi-disciplinary project teams, ideally a track record of leadership of such project teams demonstrating the ability to lead without authority.

Principal CMC Technical Development Leader:

• Ph.D. in Science with 12+ years or M.S. in Science with 15+ years or B.S. in Science with 18+ years of Animal or Human Health product development experience.
• Position requires major experience in Animal or Human Health product development.
• Proven track record of interacting efficently with commercial manufacturing organizations.
• Excellent organizational skills and familiarity with developing drug product development timelines.
• Deep understanding of relevant health regulatory agency requirements for new drug product submissions, ideally animal health related experience.
• Leadership of global, multi-disciplinary teams involving the ability to lead without authority.

Eligibility Requirements:

• Must be legally authorized to work in the United States without restriction.
• Must be willing to take a drug test and post-offer physical (if required).
• Must be 18 years of age or older.

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