Description:
Transfer of analytical methods (Brand) from R&D to Operations - between BI sites and/or to external CMOs - including supporting analytical development, method validation, and lifecycle support. Troubleshoot and resolve obstacles during method development, transfer, validation and commercialization as well as provide additional technical support as needed. Serve as Team Member Quality for one or more Brand Products. 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. This role is based on-site at our Columbus, Ohio location with hybrid flexibility of a minimum of 2 days per week on-site.
Duties & Responsibilities:
Collaborate with and influence development partners/customers (e.g. BI sites, External CMOs) during the development and registration of new product NDAs ensuring that all project timelines are met. In collaboration with DRA, ensures accuracy and appropriateness of analytical specifications and validation packages (includes excipients, APIs, packaging components, drug products and stability).Provides technical guidance and expertise to assess the viability of new analytical techniques and methods for use in the BI network and with CMO's. Leverages expertise to drive new methodologies to impact globally. Collaborates with and influences management and or team members of development partner groups to ensure alignment between development and operational goals, project activities, and initiatives. Represents Launch Analytics, BI US Operations in the technical transfer of new and lifecycle products(Brand, CHC) from R&D to Operations - between BI sites and/or to external CMOs. Evaluates BI/CMO laboratories either on/off site for technical capability and GMP compliance. Provides risk assessment regarding technical/personnel capabilities and the probability of transfer success. Ensures appropriate training and transfer of analytical methods and specifications to/from BI and/or CMO laboratories. May create or provide technical/regulatory direction on documentation (e.g. Method Transfer Protocols, Method Transfer Reports, equipment checklists, etc.).Support CMOs post transfer with analytical troubleshooting or investigations (including market actions).Provide technical expertise and issue resolution on analytical discrepancies or differences in results between testing sites(BI or CMO).Regularly leads functional and cross-functional investigations to determine root causes, assess product impact, and determine possible paths forward. Collaborate with and influence organizational partners to support these initiatives, as necessary. Perform Analytical Method and Validation Risk Analysis of new & lifecycle products (Brand and CHC) as the Operations team representative, collaborate with and influence development and CMO partners as needed to ensure technical viability and compliance. Identify and escalate critical risk areas, and propose/drive remediation plans to address them. Prepare equipment checklists, analytical method transfer protocols/reports, and other documents for assigned products/projects to meet established project timelines. Liaise with Regulatory Affairs to support documentation required for product filing; prepare analytical related documentation for submission per Corporate Guidelines, guide and influence regulatory affairs on analytical or product topics. Liaise with Quality Management to support and or drive process changes. Meet cGMP, FDA, DEA, OSHA and other applicable regulatory and company guidelines. Mentor and train others on best practices regarding documentation (including validation strategy & protocol development and validation report documentation) across the organization. Participate in and or lead the USP Monograph and Pharmacopeia Forum (General Chapter) Review Process. Perform technical reviews on proposed monographs and evaluate the impact on Brand US Operations. Assist in the maintenance of accurate files and source documentation that will support the activities of the department and satisfy corporate and regulatory requirements.
Requirements:
B.S. degree in Chemistry, Pharmacy, or related scientific discipline plus a minimum of eight years experience in Analytical Chemistry in the Pharmaceutical Industry. Alternatively, a M.S. degree in Chemistry, Pharmacy, or related scientific discipline plus a minimum of six years experience in Analytical Chemistry in the Pharmaceutical Industry. Alternatively, a Ph.D. degree in Chemistry, Pharmacy, or related scientific discipline plus a minimum of five years experience in Analytical Chemistry in the Pharmaceutical Industry (Internship or co-op programs may qualify for work experience for those with Ph.D. degrees.)
Required:
Experimental Methodology: Extensive knowledge and experience with Analytical Method Development, Validation and Transfer in the pharmaceutical industry under applicable regulatory guidelines.
Demonstrated advanced technical knowledge and expertise in the operation of key analytical instrumentation (HPLC, GC, Dissolution, Particle Size Analyzers)in the analysis of multiple pharmaceutical dosage forms, APIs and excipients. Experience with advanced instrumentation, such as MS, is highly desired.
Demonstrated ability to define and initiate project plans and drive milestones.
Complex Problem Solving: Expert knowledge of and ability to apply investigative techniques to uncover problem areas, determine root causes, and implement corrective actions. Uses problem solving abilities requiring attention to detail, accuracy, and scientific judgment. Develops solutions to a variety of problems of high scope and complexity, as defined in Accountabilities section.
Computer Skills: Expert computer skills with the ability to enter data into and retrieve information from various software programs such as Microsoft Office (Work, Excel, PowerPoint, and Outlook). Experience with laboratory systems such as Empower, Labware, TrackWise, or other data systems is required.
Project Management: Organizational skills and ability to influence and manage the execution of project milestones.
Initiative: Must have the ability to work without supervision using scientific judgement and scientific competency for both for strategic decisions and tasks of high complexity. Exercises latitude in determining objectives and approaches to assignments.
Teamwork: Demonstrated ability to be an active participant on teams of high complexity, and to lead/facilitate teams on tasks of high complexity.
Training: Skills to effectively educate colleagues on technical principles, analytical fundamentals, etc. (e.g. explaining analytical details at meetings).Mentoring/Coaching: Ability to coach and or mentor both in and out of reporting structure (eg. scientists II or III)
Desired Skills, Experience and Abilities
Preferred:
Extensive knowledge and understanding of applicable laws and regulations regarding development and validation of analytical methods, including cGMP, DEA, and FDA guidances. Demonstrated knowledge of pharmaceutical formulation development and drug development/launch processes. Demonstrated ability to successfully develop, validate, and/or transfer analytical methods to support testing of modified/extended release, nasal suspensions, soft gels, bead/pellet coated products, film coated products, and/or novel delivery systems.
