Assoc. Dir., External Alternative CMC Dev (Analytical/QC)

Job Description:

Assoc. Dir., External Alternative CMC Dev (Analytical/QC) at Boehringer Ingelheim Pharmaceuticals, Inc. in Ridgefield, CT (Telecommuting permitted: work may be performed in any location in the U.S.)

Job Duties: Review and approve supplier qualification for analytical chemistry testing laboratories and assure that only qualified contract laboratories are used to support the projects. Participate in vendor and internal audits as needed.  Provide role dependent leadership and direction to development project teams to ensure product quality guidelines are consistently met. Provide guidance and expertise to advance specific projects or evaluate and propose new technologies and concepts. Drive and manage method development, validation, and transfer activities at vendors for New Chemical Entity (NCE) projects. Proactively identify and troubleshoot issues to prevent missed timelines and identify opportunities for improvement to ensure successful on-time delivery of analytical development/Quality Control (QC) related work packages. Review and sign respective specifications, protocols and test procedures as needed for external partners. Perform technical review of 3rd party related analytical documents according to Quality assurance agreement (QAA). Confirm suitability of validation of analytical methods that are used for release testing of materials that are intended to be used in clinical trials. Provide both technical and operational Analytical expertise in developing and implementing appropriate cGxP compliant procedures, OOX investigations, deviations, CAPA, change control, drafting specification justification, and operational improvements, etc. to ensure continued compliance with regulations. Ensure that the required testing of drug substance, packaging materials, excipients, IMP intermediates and IMPs have been carried out according to cGMP as required and are in compliance with master documents as well as QAA. Oversee and manage the external stability program(s) and ensure on-time test, data review, and real-time monitoring of stability data. Help prepare/approve stability protocols and interim stability reports. Assign appropriate shelf life/retest period.Ensure reliable storage of retain samples and sample shipment to vendors. Ensure compliance with all required training, safety, regulatory, HR, intellectual property, GMPs and GLPs (where applicable), and corporate ethics and policies. Manage and support the investigation of quality events in the context of release and stability testing in collaboration with internal and external quality systems. Monitor contract laboratory activities to ensure compliance and timeliness of certificates of approval and reports. Assemble data packages in support of specification and method changes associated with company products. Represent QC in cross-functional teams within internal and external interface(s). 

Description (cont'd)

Job Duties (cont'd): Prepare clear technical reports, publications, and oral presentations. Independently communicate results in the form of reports and/or presentations. Author regulatory filing documents (IND, CTA, IMPD, and NDA/MAA). Collaborate effectively with the external global scientific community and supplier organizations. Introduce new practices and technologies into the company and lead project/technology transfer to late Development, Operations. Understand current regional and global regulations and legal requirements as well as company policies and procedures as relevant to areas of expertise. Apply knowledge to ensure safe and compliant practices, manage risk and maximize project probability of success. Contribute to positive EACD/Development and company images and reputation with respect to ethical standards, quality, and technical excellence. Demonstrate fiscal responsibility with respect to cost of experiments, technology, external collaborations, and travel.  Assist in control strategy preparation. *Telecommuting permitted: work may be performed in any location in the U.S.

Work Schedule: 40 hours per week (8:00am to 5:00pm)

Job Requirements: Bachelor's degree (U.S. or foreign equivalent) in Pharmaceutical Science, Chemistry, Analytical Chemistry, or a related field and twelve (12) years of progressive, post-bachelor's experience in the job offered or in a related role OR Master's degree (U.S. or foreign equivalent) in Pharmaceutical Science, Chemistry, Analytical Chemistry, or a related field and ten (10) years of experience in the job offered or in a related role. Must have ten (10) years of experience with: analytical sciences, Chemistry Manufacturing and Controls (CMC) during development, current Good Manufacturing Practices (cGMPs), laboratory management, good documentation practice, and internal and external scientific communities; preparing and managing Good Manufacturing Practices (GMPs) documentation, technical reports, and oral presentations both to scientists (internally and externally) and senior level management; adhering to International Council for Harmonization (ICH) quality guidance as well as European Union (EU) and Food and Drug Administration (FDA) drug manufacturing regulations; and drug product analytical development, validation, and transfer. Must have five (5) years of experience with: building relationships and working with Contract Development and Manufacturing Organizations (CDMOs),  Contract Manufacturing Organizations (CMOs), and external vendors; managing indirectly or directly, leading, and motivating others; managing and directing teams and vendors in Quality Control; managing projects and working with cross-functional teams comprised of internal and external contacts; communicating and negotiating with internal and external project team members on drug product analytical topics, including scheduling, investigations plan, and alternative concepts; authoring and reviewing documents for regulatory application submissions; and providing analytical or testing support for various formulation types, including tablets, Capsules, Oral solutions powder, and Injectable powder. Up to 20% domestic and international travel required.