(Archived) AD Drug Substance Analytic - External Alternative CMC Development

Description

The EACD department develops new CMC paradigms for more effective and efficient NCE development and for advancement of NCE-like Alternative Medicinal Therapeutic Product (ATMP) projects. The Associate Director, Analytical/QC will be responsible for leading activities related to Analytical Development/Quality Control of NCE projects within the EACD and is expected to support non-traditional EACD strategies for NCE CMC development accessed through external collaborations supplemented by academic resources and internal Boehringer capabilities as required.

The incumbent will represent Analytical Development/QC functions on the EACD project teams, and will be responsible for fiscal and technical delivery of his/her projects in conjunction with other members of the EACD Dept. The incumbent will oversee operations pertaining to analytical development/quality control at contract testing laboratories for drug substance. This responsibility includes but is not limited to contracting, vendor oversight, project management, documentation and data review, and exceptions management.

The incumbent will also help support the EACD network of competencies for design, development and supply of drug substance 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.

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, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

Duties and Responsibilities

• Review and approve supplier qualification for analytical 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 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/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 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 Quality assurance agreement (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.

Duties and Responsibilities (Continued)

• Ensure compliance with all required training, safety, regulatory, HR, intellectual property, GMP’s and GLP’s (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 BI products. Represent QC in cross-functional teams within internal and external interface/s.
• Author regulatory filing documents (IND, CTA, IMPD, and NDA/ MAA). Assist in control strategy preparation
• Prepare clear technical reports, publications, and oral presentations. Independently communicate results in the form of reports and or presentations.
• 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.
• Understand current regional and global regulations and legal requirements as well as BI 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 BI images and reputation with respect to ethical standards, quality, and technical excellence.
• Demonstrates fiscal responsibility with respect to cost of experiments, technology, external collaborations, and travel.
• Analyze company internal processes in order to accelerate CMC development activities and negotiate lean development approaches with internal stakeholders while guaranteeing drug substance quality and compliance.
  

Requirements

• Master's Degree in pharmaceutical science, analytical chemistry or equivalent with 10+ years OR a Ph.D. degree with 8+ years of pharmaceutical industrial experience in NCE analytical development functions.
• Demonstrates broad and in-depth understanding of and experience in analytical sciences, CMC development, cGMP, laboratory management, good documentation practice, and internal and external scientific communities
• Experience in building relationships and working with CDMOs/CMOs and external vendors. Proven ability to indirectly or directly manage, lead, and motivate others.
• Experience in managing and directing teams/vendors in Quality control. Experience with managing projects and working with cross-functional teams comprised of internal and/or external contacts
• Demonstrated ability to prepare/manage GxP documentation, technical reports, publications, and oral presentations both to scientists (internally and externally) and senior level management
• Working knowledge ICH quality guidance, EU, and FDA drug manufacturing regulations. Excellent written and oral communication skills. Ability to work a flexible work schedule to accommodate program priorities and international activities as needed
• Late-stage NCE drug substance analytical development/transfer experience
• Effective communication and negotiating skills
• Be able to travel (domestic and international) for business reasons up to 10%.
• 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.
  

Desired Experience, Skills, and Abilities:

• Recent hands-on experience in methods development, validation, and transfer
• Management of external CROs and CDMOs/CMOs is a plus
• Existing alliances with academia and relevant external scientific bodies are helpful
  

Compensation Data

This position offers a base salary typically between $135,000.00 and $232,000.00 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