CMC Technical Development Leader, Biologics

Company: Boehringer Ingelheim
Location: Athens
Posted on: September 12, 2021

Job Description:

Description:

Description\:

The CMC Technical Development Leader (TDL) is the project leader responsible for fast and efficient development of robust new biological products. The leader ensures complete CMC technical packages, successful global regulatory approvals by relevant health’s authorities, and scale-up and industrialization of the finished product.  

The 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.

The Technical Development Team (TDT) 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.

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, Global Project Leader (GPL),  functional experts and managers.
• 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 respective 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 (GPL 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 Development and Operations in order to ensure a smooth hand-over of assigned projects as they move from development to industrialization.
• Ensure alignment with Pharmaceutical or Biological Development Heads as well as Analytical Development and Formulation Development Heads and facilitates best practices and alignments across the Development organization.
• Develop strategic technical development plans that simultaneously meet the needs of a global regulatory landscape while operating within the constraints of the animal health Development and manufacturing infrastructure
• Need to have alignment of activities with expectations of major regulatory health authorities such as FDA-CVM, EMA, USDA, EPA.
• 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

Requirements\:

• Ph.D. from an accredited institution in Science with seven-plus (7+) years of Animal or Human Health product development experience; Or
• M.S. from an accredited institution in Science with ten-plus (10+) years of Animal or Human Health product development experience; Or
• B.S.  from an accredited institution in Science with twelve-plus (12+) years of Animal or Human Health product development experience.
• At least seven (7) years of experience in pharmaceutical drug development or biological development.
• Position requires significant experience in Animal or Human Health product development. 
• Experience interacting with commercial manufacturing organizations. 
• Familiarity with relevant health regulatory agency requirements for new drug product submissions, ideally animal health related experience.
• Excellent knowledge of development, i.e. the position requires expertise in the development of finished products including a high-level understanding of the regulatory, quality and clinical requirements. 
• Ability to coordinate the efforts of diverse resources towards achieving a common deliverable. 
• Understanding both the concepts and constraints of finished 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 product developments which resulted in successful products on the market and/or multiple patents filed.
• Technical understanding of process development and good technical problem solving skills.
• Good organizational skills and familiarity with developing drug product development timelines. 
• Leadership of global, multi-disciplinary teams involving the ability to lead without authority.
• Strong interpersonal skills and communication skills.
• Operational and strategic thinking.
• Skilled in conflict resolution and negotiation.
• Achievement focused with appropriate alignment for regulatory and quality requirements.
• Strong decision making skills with the ability to solve problems.
• Transparent in communication of failures.
• Positive attitude and willingness to take risks.
• 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.
• Willingness to travel internationally.
• Fluency in English is mandatory and ability to communicate in another language such as German or French or willingness to learn the language is beneficial.

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.

Who We Are\:

At Boehringer Ingelheim we create value through innovation with one clear goal\: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company we focus on long term performance. We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture. Learning and development for all employees is key because your growth is our growth.

Want to learn more?  Visit boehringer-ingelheim.com and join us in our effort to make more health.

Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities. All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.

Keywords: Boehringer Ingelheim, Athens , CMC Technical Development Leader, Biologics, Other , Athens, Georgia