Associate Director / Sr. Associate Director, Analytical External Alternative CMC Development (EACD)

Description

This is a multi-level posting. Candidates will be hired in at the level based on education, experience and business need.

Boehringer Ingelheim is seeking an experienced Associate Director or Senior Associate Director, Analytical to join the External Alternative CMC Development (EACD) team at our Ridgefield, CT facility.

EACD is dedicated to pioneering new CMC paradigms that enable more efficient and effective development of new chemical entities (NCEs) and NCE-like molecules, including oligonucleotides. In this role, you will lead all external analytical development and quality control (QC) activities for assigned projects, supporting the broader CMC development strategy within EACD.

As the analytical subject matter expert (SME), you will collaborate with internal and external stakeholders to develop and execute CMC strategies. You will be responsible for the technical and fiscal delivery of your projects and represent analytical/QC functions in EACD project teams and higher-level governance forums. You will help shape and advance comprehensive EACD strategies by integrating capabilities from a global network of external suppliers and internal partners. This includes building competencies for design, development, GMP-compliant clinical supplies, and delivery systems tailored to EACD programs. Your leadership will drive continuous improvement and sustain an innovative portfolio of technologies and processes that support next-generation CMC development.

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, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

Duties & Responsibilities

• Lead and manage all drug substance (DS) and drug product (DP) analytical and quality control (QC) deliverables for global project teams assigned to the External Alternative CMC Development (EACD) department.
• Drive and implement innovation strategies that enhance the scientific and business impact of the department, expanding its influence across Boehringer Ingelheim.
• Develops and maintains 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.
• 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 and promotes high visibility and influence of the department with outside organizations including academic institutions, regulatory agencies and industrial/academic associations.
• Define and manage budgetary requirements for projects, technology developments; manage and adjust activities to operate within budgetary goals.
• Collaborate with global external thought leaders from academia, 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.

Requirements

Requirements for Associate Director

• Master's Degree (e.g. MBA, MSc) or equivalent in chemistry, chemical engineering, or pharmaceutical sciences from an accredited institution, with ten-plus (10+) years of experience; OR
• Ph.D. degree from an accredited institution with eight-plus (8+) years of industrial experience in analytical development, QC and/or pharmaceutical analysis. 

Requirements for Senior Associate Director

• Master's Degree in chemistry, pharmaceutical science, or c