CMC Technical Development Leader

Description

The Technical Development Leader (TDL) is responsible for driving the development of and implementing a scientifically sound technical strategy for biological new product development projects from late research through launch (stages R3- D4) as the leader of Technical Development Teams.

The Technical Development Team is a sub-team of the Core Project Team (CT) with delegated responsibilities in the areas of Analytical, Formulations, Process, Regulatory CMC, Packaging and Operations.

The Technical Development Leader must work globally and cross-functionally to manage the technical development portion of assigned projects to ensure the development of a robust technical documentation package and final product that can be registered with relevant health authorities and successfully industrialized.

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of 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

• Formulate a scientifically sound and business driven technical strategy, in line with overall project strategy, involving Research Leader (RL), Global Development Leader (GDL), departmental project leaders and functional experts (as appropriate).

• Lead multi-disciplinary global teams in line with Boehringer Ingelheim values and behaviors. Build strong team spirit and promote knowledge exchange within and between teams. Ensure smooth operation and cross-functional alignment.

• Implement and manage the technical development strategic plan for assigned projects (internal or external) following the Biological Development Guide, Technology Transfer Process and other required guidelines/procedures. Ensure all critical project milestones are met while maintaining a high level of quality.

• Proactive communication of overall project strategy, key issues/risk and any other critical topics in a timely manner to the Technical Development Team (TDT), appropriate management level (i.e. RL, GDL and line management) and relevant stakeholders.

• 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.

• Prepare and present information related to the technical development aspects, as requested, at internal governance meetings and external health authority meetings.

• Manage the relationship between R&D and Operations in order to ensure a smooth hand-over of assigned projects as they move from development to industrialization.

• The output of this role is governed by regulatory GXP requirements. Need to have alignment of activities with expectations of major regulatory health authorities such as FDA-CVM and EMA.

• This role also needs to ensure alignment with BI Quality standards (SOPs) and contemporary operating procedures of the Manufacturing group (Operations).

Requirements

• Ph.D. from an accredited institution in Science with five-plus (3+) years of biological drug product development experience.
• M.S. from an accredited institution in Science with eight-plus (5+) years of biological drug product development experience.
• B.S. from an accredited institution in Science with ten-plus (8+) years of biological drug product development experience.
• At least three (3) years of experience in biological drug development.
• Excellent knowledge of biological development, i.e. the position requires expertise in the development of biologicall drug products including a high-level understanding of the regulatory, quality and clinical requirements.
• It will require the ability to coordinate the efforts of diverse resources towards achieving a common deliverable.
• Understanding both the concepts and constraints of drug product development as well as the existing capabilities in manufacturing will be very useful in optimizing the technical development timeline.
• Ideally, involved in more than one drug product developments which resulted in successful products on the market and/or multiple patents filed.
• Position requires significant experience in biological drug product development. The following attributes will be critical for this position:
• Experience interacting with commercial manufacturing organizations.
• Good organizational skills and familiarity with developing drug product development timelines.
• Familiarity with EMA and FDA regulatory requirements for new drug product submissions, ideally animal health related experience.
• Leadership of global, multi-disciplinary teams involving the ability to lead without authority.
• Achievement focused with appropriate alignment for regulatory and quality requirements.
• Willingness to travel internationally.
• Ability to challenge teams and functional heads and able to recommend innovative alternatives.
• Capability to deal with a variety of challenging matters including set-backs and failures.

Desired Skills, Experience and Abilities

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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