Description

We are seeking a highly skilled and experienced Director to join our External Alternative CMC Development (EACD) team. The ideal candidate will have expertise in drug product formulation and process development, with a strong background in New Chemical Entities (NCEs) and other modalities. This role involves leading all aspects of drug product development, primarily through external collaborations with Contract Development and Manufacturing Organizations (CDMOs). The Director will support all drug product-related CMC activities within EACD, pioneering new CMC paradigms to enhance NCE development and advance similar projects (oligonucleotides, RNA, DNA, peptides). This position requires onsite presence at Ridgefield, CT, and reports to the Vice President, EACD.

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 Drug Product Development: Oversee the formulation and process development of drug products, ensuring successful transition from early-stage development to late-stage and commercial manufacturing.Technical Expertise: Utilize extensive knowledge of NCEs and oligonucleotides to craft innovative drug product formulations and processes.Project Management: Handle multiple projects concurrently, coordinating efforts with cross-functional teams and external CDMOs to adhere to project timelines and deliverables.Vendor Management: Partner with CDMOs to guarantee high-quality and timely delivery of drug products, encompassing vendor selection, qualification, oversight, and project management.Regulatory Compliance: Ensure all drug product development activities are aligned with pertinent regulatory guidelines and standards.Innovation and Improvement: Advocate and implement cutting-edge techniques and concepts to refine drug product development processes and outcomes.Team Leadership: Provide leadership and mentorship to a team of scientists and engineers, fostering a collaborative and high-performance work environment.Stakeholder Engagement: Engage with internal and external stakeholders to advance drug product development initiatives.Requirements Ph.D. Degree from an accredited institution in Pharmaceutical Sciences, Chemistry and / or Chemical Engineering or equivalent with ten-plus (10+) years of industrial or academic experience in drug product formulation and process development, with a focus on NCEs and oligonucleotides.CDMO Collaboration: Proven experience working with CDMOs, managing external collaborations, and ensuring successful project outcomes.Technical Skills: Extensive knowledge of drug product formulation, process development, and associated analytical techniques.Regulatory Knowledge: Working knowledge of ICH quality guidance, EU, and FDA drug manufacturing regulations.Project Management: Demonstrated ability to manage complex projects with external CDMOs, building strong partner relationships.Late-Stage Development: Experience in late-stage drug product development and/or commercial manufacturing.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.Compensation Data

This position offers a base salary typically between $200,000.00 and $316,000.00 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.

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.
 Desired Skills, Experience and Abilities CMC Development: Exposure to and understanding of the Pharmaceutical CMC Development process.Experience in both early and late-stage drug product development and/or commercial manufacturing.Project Management: Experience managing projects with external CROs and CDMOs/CMOs, building partner relationships, and directing teams/vendors.Leadership: Proven ability to manage, lead, and motivate teams both directly and indirectly.Communication: Excellent written and oral communication skills, with experience authoring publications and delivering presentations to both scientific and senior management audiences.Documentation: Ability to review and approve GxP documentation and technical reports.Community Engagement: Active in internal and external scientific communities.Innovation: Ability to propose, articulate, evaluate, and drive innovative strategies for drug product development.Existing Alliances: Existing alliances with academia and relevant external scientific bodies/consortia, with experience in contracts, IP, and legal matters.Team Participation: Demonstrated ability to lead and participate in interdisciplinary and international teams.Flexibility: Ability to work a flexible schedule and travel (domestic and international) for business reasons (5-20%).Knowledge: Knowledge of oligonucleotide, RNA/DNA, or polypeptide projects.