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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 chemical engineering from an accredited institution or equivalent with 12+ years of experience OR;
  • Ph.D. degree with 10+ years of industrial experience in analytical development, QC and/or pharmaceutical analysis.

Requirements for Both Levels:

  • Experience managing projects with external CROs and CDMOs/CMOs, building partner relationships with CDMOs/CMOs and external vendors
  • Experience managing and directing teams/vendors in process research/development, drug substance synthesis, and crystallization
  • Experience working effectively in cross-functional teams comprised of internal and/or external contacts
  • Experience authoring publications and delivering oral presentations to both to scientists (internally and externally) and senior level management
  • Proven ability to indirectly/directly manage, lead, and motivate others
  • Demonstrated broad and in-depth understanding of and experience in: organic chemistry and associated analysis techniques (NMR, GC, LC, XRPD, etc.), drug substance route scouting, process research, process development and manufacturing, solid state/crystallization, and cGMPs
  • Active in internal and external scientific communities
  • Demonstrated ability to review and approve GxP documentation and technical reports.
  • Working knowledge of ICH quality guidance, EU and FDA drug manufacturing regulations as related to drug substance
  • Excellent written and oral communication and negotiating skills
  • Ability to work a flexible work schedule to accommodate program priorities and international activities as needed
  • Ability to travel (domestic and international) for business reasons (up to 20%)
  • Onsite/Flex*: This position is site based with flexibility for remote working. Working onsite a minimum of 2-3 days per week is required. Remote working norms will be clarified during the interview process.
  • Position will be filled commensurate upon experience

Desired Experience, Skills, and Abilities:

  • Both early and late-stage analytical development and QC experience would be desirable
  • Hands-on experience managing oligonucleotide projects is a plus
  • Existing alliances with academia and relevant external scientific bodies / consortia

Compensation Data

This position, Associate Director, External Alternative CMC Development (EACD) , offers a base salary typically between $140,000.00 and $222,000.00 USD.  The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please click here.

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