EACD develops new CMC paradigms for more effective and efficient NCE development. The primary focus is expedient advancement of primarily small molecule therapeutics as well as potentially including mid-sized molecules (e.g. oligonucleotides, polypeptides),. The Associate Director, Chemistry will be responsible for leading activities related to drug substance development within EACD, with a focus on late-stage clinical development CMC activities.
The location for this position is flexible (can be primarily remote), and will report into Director, EACD in Ridgefield, CT.
The incumbent will oversee operations pertaining to drug substance at Contract Development and Manufacturing Organizations (CDMOs). This responsibility includes, but is not limited to, vendor oversight, project management, data review, and exceptions management (quality). The incumbent is expected to support CMC project strategies for drug substance and CMC development accessed through external collaborations and supplemented by academic resources and internal BI capabilities as required. The incumbent will represent all Drug Substance activities on project teams where they are the EACD Team Member and be responsible for fiscal and technical delivery of his/her projects in conjunction with other members of the EACD Dept. The incumbent will also help support the EACD network of competencies for design, development, and supply of drug substance, drug product, and delivery systems required for EACD programs, to drive continuous improvement and sustain an innovative portfolio of technologies and processes that will advance CMC Development at BI.
Duties & Responsibilities\:
- Manage all drug substance deliverables for programs assigned to EACD. The individual will interact with internal as well as external multidisciplinary teams to ensure successful on-time delivery of drug substance and related work packages.
- This position also includes responsibilities assisting with authoring and ensuring consistency of regulatory filings (INDs, CTAs, IMPDs, and NDAs/BLA/MAA).
- Champion and implement innovative techniques/ideas/concepts to progress BI R&D projects for both NCEs and NCE-like entities primarily using external capabilities with some application of internal knowledge and techniques/expertise to facilitate partnerships as appropriate.
- Manage drug substance activities at external CDMOs. Coordinate meetings, review technical data, and provide scientific input to help partners and drive projects. Review documents (Batch records, specifications) for accuracy and approve GMP activities as required. Proactively identify and troubleshoot issues to ensure project timelines are met. Monitor CDMO for compliance to cGMP practices and compliance with Contractual Agreements (MSA, SOW) and the Quality Assurance Agreement (QAA).
- Maintain and expand the EACD network of CDMO partners. Participate in external meetings to identify new opportunities for EACD in terms of resources, technology, etc. Identify areas for improvement in all areas of CDMO partner work and communication. Maintain transparent and respectful communication and work together as a "partner" with external CDMOs.
- Collaborate effectively with the BI and external global scientific communities, including CDMOs. Maintain current awareness of external supplier vendor capabilities, scientific literature, leading academic and technology innovators for key areas, etc. Introduce new practices and technologies into BI and lead project/technology transfer to late Development/Operations.
- Participate in vendor and internal audits as needed. Contribute to BI's quality systems and culture.
- Ensure compliance with all required training, safety, regulatory, HR, intellectual property, cGMP's (where applicable), and corporate ethics and policies. Review and approve supplier qualifications and ensure third parties comply with relevant BI and regulatory processes and procedures.
- Understand, appreciate and have working knowledge of current national and international regulations and legal requirements relevant to area/s of expertise; Apply knowledge to ensure safe and compliant practices, manage risk, and maximize opportunities for projects to succeed.
- Contribute to departmental administration; Demonstrate fiscal responsibility with respect to cost of experiments, technology, external collaborations, and travel. Investments must be phase-appropriate and deliver in conjunction with other associated/dependent activities being advanced by other members of EACD. Liaises with partner lines to ensure appropriate contracts, SoW, and payment schedules are utilized in making EACD investments.
- Prepares clear technical reports, publications, and oral presentations. Independently communicate results in the form of reports and or presentations; Deliver updates to senior level management in context of overall project goals.
- 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.
- Ph.D. Degree in chemistry or chemical engineering with 8+ years of industrial experience in chemical process development and/or manufacturing support. A Master's Degree or equivalent with 10+ years of experience would be acceptable.
- Late stage and/or commercial DS development and manufacturing experience, including FMEA analyses, quality risk assessments, process performance qualification, and manufacturing technology transfers.
- Demonstrated broad and in-depth understanding of and experience in\: organic chemistry and associated analysis techniques (NMR, GC, LC, XRPD, etc.), drug substance process research, process development and manufacturing, solid state/crystallization.
- Experience managing projects with/at external CROs and CDMOs/CMOs desired, building partner relationships with CDMOs/CMOs and external vendors. Proven ability to indirectly/directly manage, lead, and to motivate others.
- 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.
- Demonstrated ability to review and approve GxP documentation and technical reports.
- Experience authoring publications and delivering oral presentations to both to scientists (internally and externally) and senior level management.
- Working knowledge and phase-appropriate application of ICH quality guidances, EMA and FDA manufacturing regulations as related to drug substance.
- Excellent written and oral communication and negotiating skills.
- Active in internal and external scientific/industry communities.
- 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 (5-20%).
- 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.
- This position will require individuals to be fully vaccinated against COVID-19 or have an approved medical or religious accommodation. Click here for more information on the vaccine mandate and COVID-19.
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.
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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's 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.