
Ridgefield, CT Director Of Solid State Science & API Engineering (SSAE), Material Analytical Science Unit
Boehringer Ingelheim
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Job description
Description The Director of SSAE, Material and Analytical Sciences (MAS) provides strategic, scientific and managerial leadership of the SSAE Group within the MAS Department. Material and Analytical Sciences screens, develops, and applies innovative, state-of-the art scientific methods and tools, in-silico and digital solutions, that facilitate development of drug substance, drug product and overall process understanding and robustness, thereby enabling successful development of a highly diverse and complex first-in class portfolio of NCE (New Chemical Entity) and NTM (New Therapeutical Modality) pipeline assets in Candidate Selection (CS) relevant characterization and early to late CMC development stages. A focus is on the development and application of modelling & simulation tools to accelerate and streamline development of DS and DP (predict first - confirm later). MAS works with the global Development functions (DEV NCE and DEV Biologicals), as well as Operations and Animal Health where applicable. The Director of SSAE ensures that the group meets the qualitative and quantitative goals and standards as defined by the international and local Development CMC requirements. This role develops talent through effective and agile mentorship and assignments, and continuously develops the group, including hiring of skills and competencies needed to successfully drive Boehringer’s global development portfolio. 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 Company’s success. 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, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim´s high regard for our employees. Duties & Responsibilities • Provides leadership and technical guidance in ensuring drug substance and drug product deliverables, and provision of expert consultation across global business units, in particular global Development CMC and Operations, , etc. • Builds networks and actively manages key interfaces, stakeholders and customers across the development functions and beyond. • Collaborates effectively with global SMEs & leaders across disciplines and sites. • Develops and implements innovation strategies that enhance scientific and business value of MAS and extend its scope of influence within BI. • Develops talent by mentoring to grow capabilities and responsibilities. • Recruits, retains and develops high-quality staff. • Participates in interdisciplinary and/or international Boehringer Ingelheim projects as requested by BIPI and international senior management. • Initiating, executing, and driving initiatives for the Department or wider organization as applicable. • Ensures compliance with all required training, safety, regulatory, HR, laboratory notebook, intellectual property, GMP´s and GLP´s (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. • Develops budgetary requirements for projects and laboratory operations, manages and adjusts activities to operate within budgetary goals. Requirements • Ph.D. degree or equivalent with focus on pharmaceutical relevant science (esp. in Chemistry, Chemical Engineering) with ten plus (10+) years of industrial or academic experience, including managing groups of more than ten (10) individuals. • Proven ability to manage, lead, and motivate others. • Ability to propose creatively and independently, articulate, evaluate and drive innovations that bring value through improving efficiency and effectiveness in DS and DP development (such as process understanding). • Demonstrated broad and in-depth understanding of pharmaceutical and/or analytical sciences in internal and external scientific communities. • Extended technical experiences with API crystallization, API/ intermediate isolation, and process development, plus amorphous formulation development. • Extensive knowledge on NCE/ NTM DS and DP development in various stages from pre-candidate selection till launch. • Proven track record of driving innovations and applying cutting-edge scientific principles in development of robust, efficient processes and formulations, analytical methods, in silico and digital tools and technologies/concepts that expand capabilities beyond the current state. • Demonstrated ability to collaborate with, negotiate and influence business partners in CMC Development and other business functions (Operations, etc.). • Demonstrated ability to lead/ drive 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 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 BI business procedures. Eligibility Requirements
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