Associate Director, External Alternative CMC Development (Formulations)

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.Description: The EACD group develops alternative CMC paradigms for more effective and efficient NCE and NCE-like Alternative Medicinal Therapeutic Product (ATMP) projects for development. The Associate Director, Formulations at EACD will be responsible for spearheading all activities related to the Drug Product Design and Development function at Boehringer Ingelheim (BI) in support of all CMC development activities. While the location for this position is flexible (remote/on-site at Ridgefield), the position will report into Director, EACD in Ridgefield, CT.The incumbent will oversee operations pertaining to drug product design and development at contract research/manufacturing organizations. This responsibility includes but is not limited to vendor oversight, project management, data review, and exceptions management. The incumbent is expected to support alternative BI CMC project strategies for Drug Product development accessed through external collaborations. The incumbent will be responsible for fiscal and technical delivery of his/her projects in conjunction with other members of the EACD Dept. The incumbent will represent all Drug Product Design and Development activities on project teams representing EACD. The incumbent will also help support the EACD network of competencies for design, development and supply of API, DP and any delivery systems required for the EACD programs, to help drive continuous improvement, and to sustain an innovative portfolio of technologies and processes that will advance CMC Development.Duties & Responsibilities: Manage all drug product 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 product 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 all drug product 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).

Possess demonstrated ability in CRO and CDMO management. 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.

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.

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.

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.

Consult 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.

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.

Requirements: REQUIRED: Master's Degree in chemistry, pharmaceutical science, or chemical engineering or equivalent with 10+ years OR a Ph.D. degree with 8+ years of industrial experience in the chemistry, pharmaceutical science or chemical engineering aspects of drug product development (i.e.: pre-formulation, formulation development, and manufacturing)

Demonstrated broad and in-depth understanding of and experience in drug product design and development, associated analysis techniques (LC, Dissolution, XRPD, DSDC/TGA, etc.), material properties characterization, robust process development and manufacturing, and cGMPs

Be able to implement Quality by Design (QbD) and apply risk-based principles to drug product development programs, including technical & quality risk assessments, Design of Experiments, and identification of critical quality attributes (CQAs), critical process parameters (CPPs), and manufacturing control strategies

Active in internal and external scientific communities

Experience managing and directing teams/vendors in all aspects of drug product design and development. 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 and senior level management (internally and externally)

Active in internal and external scientific communities

Demonstrated ability to review and approve GxP documentation and technical reports.

Working knowledge ICH quality guidance, EU, and FDA drug manufacturing regulations

Ability to work a flexible work schedule to accommodate program priorities and international activities as needed

Excellent written and oral communication and negotiating skills.

Ability to travel (<20%) for business (domestic and international).

DESIRED: Late Stage DP development/commercial manufacturing experience

Management of parenteral drug product development projects (oligonucleotide, RNA/DNA, or polypeptide) is a plus

Existing alliances with academia and relevant external scientific bodies/consortia

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.

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.Want to learn more? Visit boehringer-ingelheim.com and join us in our effort to make more health.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.PDN1#LI-SS1 PDN1#LI-SS1 Organization: US-BI Pharma/BI USATitle: Associate Director, External Alternative CMC Development (Formulations)Location: Americas-US-CT-RidgefieldRequisition ID: 2115194