Job Description

Description:

Description\\:

Technical and (virtual) managerial leadership in the EACD Department. In support of the global PM portfolio, EACD develops new CMC paradigms for more effective and efficient NCE development and for advancement of NCE-like Alternative Medicinal Therapeutic Product(ATMP)projects. He/she develops non-traditional BI CMC project strategies for API and DP development accessed through external collaborations supplemented by academic resources and some internal BI capabilities when required. The Director EACD is responsible for fiscal and technical delivery of his/her projects in conjunction with other members of the EADC Dept. He/she represents all CMC activities on project teams where they are the EACD Team Member. External investments will be made globally to build cost effective relationships with technically and regulatory competent partners. He/she advances comprehensive EACD strategies for alternative development incorporating and influences effort and expertise from a complex matrix of external suppliers and internal partners. He/she builds the EACD network of competencies for design, development and supply of API, DP and any delivery systems required for the EACD programs, to drive continuous improvement, and to sustain an innovative portfolio of technologies and processes that will advance new CMC Development processes. Develops effective partnership and strong internal relationships based on trust, technical competence and effective planning, resource management and communication.

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\\:

Provides departmental leadership and manages all API and drug product deliverables for global project teams assigned to EACD.

Implements innovation strategies that enhance scientific and business value of the Dept and extend its scope of influence within BI

Develops appropriate external capabilities (using partners accessed from academic, CRO, CMO, drug delivery and consultant constituencies) that allow virtual provision of drug substance, drug product, drug delivery technology, etc for NCEs and NCE-like projects.

Participates in interdisciplinary and/or international Boehringer Ingelheim projects

Ensures compliance with all required training, safety, regulatory, HR, laboratory notebook, intellectual property, GMP\xe2\x80\x99s and GLP\xe2\x80\x99s (where applicable), and corporate ethics and policies

Ensures high visibility and influence of the department with outside organizations including academic institutions, regulatory agencies and industrial/academic associations

Develop budgetary requirements for projects, technology developments; manage and adjust activities to operate within budgetary goals

Consult with global external thought leaders from acaemia, industry and technology innovators regarding strategic drug discovery and development issues. Establish robust interfaces with such resources and with key internal partners (Quality, Legal, HPS) and scientific liaisons from Research and Development. Present and defend strategic positions within BI to bring continuous improvement to our CMC capabilities, scientific acumen and awareness of leading-edge approaches for next generation development.

Collaborate effectively with the external global scientific community and supplier organizations. Introduce new practices and technologies into BI and lead project/technology transfer to late Development, Operations. Provision of DS/DP supplies and appropriate GxP documentation, supplementary scientific information, for NCEs and ATMPs projects assigned to EACD.

Understand current national and international regulations and legal requirements as well as BI policies and procedures as relevant to areas of expertise. Apply knowledge to ensure safe and compliant practices, manage risk and maximize project probability of success; May represent functional area, business unit, or company to shape and influence regulations, guidelines, policies and procedures within BI or in the external environment. Contribute to positive EACD/Development and BI images and reputations with respect to ethical standards, quality and technical excellence.

Requirements\\:

Ph.D. Degree from an accredited institution or equivalent with ten-plus (10+) years of industrial or academic experience, including managing research groups of greater than ten (>10) individuals

Proven ability to manage, lead, and motivate others, with greater than six (>6) years\xe2\x80\x99 experience leading projects, employees, leaders, and business functions

Ability to creatively and independently propose, articulate, evaluate and drive innovative strategies that bring value through improving efficiency and effectiveness in API(NCEs and ATMPs)and DP development (such as process understanding)

Demonstrates broad and in-depth understanding of\\: drug substance, drug product, delivery systems and analytical sciences in internal and external scientific communities

Proven track record of applying scientific principles in development of robust, efficient syntheses formulations and manufacturing processes, analytical methods, and technologies/concepts that expand capabilities beyond the current state.

Demonstrated ability to collaborate with, negotiate and influence business partners in Global Development and other business functions (Operations, DRA, BIRI, etc)

Demonstrated ability to lead and participate in interdisciplinary and/or international teams

Effective communication, coaching, and negotiating skills

Existing alliances with academia and relevant external scientific bodies

Demonstrated ability to prepare/manage GxP documentation, technical reports, publications and oral presentations both to scientists (internally and externally) and senior level management

Ability to manage all aspects of group operations and critical components of departmental operations

Understanding of, and compliance with, all applicable regulations and relevant BI business procedures

Demonstrated ability to innovate and to manage change. Evidence of advancing new career opportunities and preferably demonstrated interest/knowledge in alternative NCE CMC paradigms and all CMC aspects/drug delivery interests for ATMP entities.

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\xe2\x80\x99s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; 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.

Boehringer Ingelheim