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:
- Overall responsibility for the CMC development of NCEs and NCE-type New Modalities with external partners in collaboration with internal R&D Teams and in conjunction with “contracted” internal support coordinated to accelerate standard NCE paradigms, enable development of all NCE-type New Modalities (ATMP) as well as advancing projects requiring novel (new to BI) delivery technology
- Liaises with internal interfaces in relevant Discovery groups (e.g. Immuno-oncology, Med Chem Vienna) to facilitate new therapeutic entities into and through development and DEV organizations such as Regulatory and QRM to ensure that abbreviated activities and new approaches needed for development of ATMPs meet regulatory and compliance requirements. Sets objectives and directions for external CMC development, defines value propositions, and supervises performance and success measurement of the API and/or DP development approaches taken in collaboration with external partners.
- Ensures the integration of external CMC development with internal R&D project teams and relevant internal line functions and interface partners (e.g. DEV NCE Dept, Q&RM, HP Supply, etc.). Provides strategic methodological + scientific consultancy for internal and external collaboration partners.
- Ensures that the collaboration with external partners follow BI’s corporate policies/procedures and follows adequate GMP, EHS and other regulations as applicable.
- Plans and controls the annual departmental budget in accordance with the DEV NCE and the Global DEV budget goals
- Promotes Our Focus and lives up to and be a role model for AAI, QCI and Learning from Failures-Culture.
- Chemistry, Pharmaceutical Science or similar; at least Master degree from an accredited instution required, preferably PhD from an accredited institution
- Greater than fifteen (>15) years of work experience in CMC area, of which greater than ten (>10) years have been with a focus on either API synthesis or formulation, drug product, or combination product development.
- Experience as a VP, Director, Group Leader or similar for at least greater than ten (>10) years
- Renowned expert in the scientific community
- Profound experience in NCE CMC development, successful management of NCE projects for at least greater than fifteen (>15) years, strategic mind with creativity and flexibility, excellent communication competencies, mature & excellent leadership and team player skills.