The Scientist III, Quality Lifecycle Management is responsible for the transfer of analytical methods (HP Brand) from R&D to Operations - between BI sites and/or to external CMOs - including supporting analytical development, method validation, and lifecycle support. This role will troubleshoot and resolve obstacles during method development, transfer, validation, and commercialization as well as provide additional technical support as needed. This role is responsible for Analytical and Quality Control support including participation in United States Pharmacopeia management team.
The Scientist III, Quality Lifecycle Management is responsible for governance of changes related to drug products (e.g., materials, equipment, formulation, process, etc.) and documentation (e.g., Corporate CRC process and CMC documentation) within BI systems, to ensure product quality and compliance to cGMPs and relevant internal, external, and international requirements. The incumbent develops project plans and manages the execution to ensure the accurate and timely completion of quality and registration relevant documentation for global registration of BI branded products, including NDA submissions and supplements for the FDA and comparable submissions for other regulatory agencies.
This role provides critical review of proposed changes to BI brand products against applicable CMC/registration documentation. The incumbent will partner with HP US Supply & Quality colleagues, DRA representatives, international project teams, and stakeholders at product manufacturing and/or packaging sites to evaluate proposed changes and determine product registration relevance and any resulting requirements regarding implementation of the changes, and to ensure preparation of CMC documentation required to support the changes is in accordance with BI Global Master Dossier standards and meets project timelines.
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 several 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 & Responsibilities\:
Provides lifecycle support (analytical expertise) for HP Products produced in the US (at CMO's) or imported for the US market.Provides technical expertise to resolve issues regarding analytical investigations (Deviations or OOX) or differences in results between testing sites (BI or CMO's).Ensures appropriate training and transfer of analytical methods and specifications to/from BI and/or CMO Laboratories.Creates documentation (e.g., technical reports, Transfer documentation, Control system strategy, risk assessments, CMC documentation, etc.) as needed.Supports CMOs with analytical troubleshooting or OOX investigations.Prepares/Reviews Analytical Documentation for submission per Corporate Guidelines. Ensures compliance with cGMP, FDA, DEA, OSHA, and other applicable regulatory and company guidelines.Participates in and/or lead functional and cross-functional investigations to determine root causes, assess product impact, and determine path forward.Collaborates with organizational partners to support these initiatives, as necessary.Leads the USP Monograph and Pharmacopeia Review Process.Performs technical reviews on proposed monographs and evaluates the impact on Brand US Operations.Assists in the preparation of proposed USP-NF monographs and interfaces/supports with USP technical staff.Maintains and updates the USP Shareroom with Pharm Forum schedule, Monograph Elaboration status, Hot Topics, training opportunities, etc.Interfaces with USP on comments and questions for proposed revisions of current chapters, monographs, or policies.Participates on or leads teams to ensure BI compliance with new or updated general chapters.Ensures maintenance of accurate files and source documentation that will support the activities of the department and satisfy corporate and regulatory requirements.Leads, facilitates, and coordinates the timely, accurate, and successful creation and/or revision, review, and archiving of quality and registration documents (Chemistry, Manufacturing, and Controls [CMC] documentation) for products for which HP US Supply and Quality has quality oversight, to support product launch readiness, product changes, registration updates, and regulatory filing supplements, etc.Collaborates with product experts, international project teams, CMC experts, DRA representatives (global and regional), and BI Corporate colleagues to ensure preparation of CMC documentation is in accordance with applicable standards (e.g., BI Global Master Dossier standards).Ensures compliance with applicable BI and regulatory agency requirements regarding submission documentation, in collaboration with DRA representatives.Supports and assists project managers for product/project teams in discussions regarding CMC documentation content (e.g., provides guidance for discussions with CMC experts and DRA).Manages the document creation process, in collaboration with relevant stakeholders, including the following\: determines and communicates requirements for multiple variants of documents for global filings; develops action plan based on CMC tracking list; coordinates activities with document authors/subject matter experts.Coordinates preparation of regional documents for site registration, regulatory statements, and other documents based on global and local requirements.Reviews CMC documentation and provides feedback to authors/subject matter experts prior to sending for review by stakeholders, to ensure the following\: compliance with applicable BI guidelines (GMD/CTD guidelines, style guides, etc.); consistency among documents that refer to one another (e.g., P200 with P340); agreement with raw data, where applicable.Tracks CMC documentation status and participates in CMC relevant meetings.Collaborates with DRA representatives and the corporate document archiving function (in Ingelheim), and other applicable stakeholders regarding CMC documentation review and archiving, to ensure CMC documentation meets requirements and project timelines.Provides Quality oversight of GxP changes that impact products under HP US Supply & Quality governance, to ensure that changes are evaluated, implemented, monitored, and documented in compliance with regulatory, corporate, and local guidelines. Consolidates and analyzes data, authors, reviews, and/or edits documentation produced to support change control requirements.Acts as change management key contact for raw material (API, excipient, packaging components), equipment, and process/formulation changes that impact products under HP US Supply & Quality governance.Conducts preliminary assessment of change request documentation (rationale, impact, and required information).Collaborates with key stakeholders (e.g., Global Regulatory Affairs, 3PQM, Corporate CRC team) to assess impact of proposed changes, determine key deliverables required to fully evaluate and implement the change, and develop regulatory & documentation strategy. Represents Change Management in cross-functional meetings such as PLMO project teams.May communicate with CMO stakeholders, develop detailed project plans, and manage projects to ensure execution of project according to schedule, depending on project. Provides feedback (e.g., to 3QPM) regarding quality and regulatory review of proposed change, change requirements, and implementation strategy.Tracks review, approval, implementation, and closure of changes.Reviews and approves documents without oversight of supervisor.Some travel (domestic and/or international) may be necessary.Manages CMC documentation preparation and review for new products, review of proposed product changes, and updates to regulatory submissions based on product changes impact all areas of HP US Supply & Quality (Quality, SCM, 3PM, Technical Services, etc.) which, in turn, impacts the ability to plan, release, and distribute product to market or file with the FDA or any other regulatory agency.High degree of freedom to author and review regulatory submission, evaluate product and/or process changes for regulatory impact, and to influence strategy regarding handling of submission documentation. The employee is typically expected to pick the best option; however, may discuss with supervisor as identifying all actions to properly assess product changes and resulting impact can be very complex and challenging.Ability to communicate across the BI organization, both domestically and internationally, regarding regulatory documentation is critical.Requires cultural awareness to work with BI personnel on International Project Teams. Tasks require the ability to recognize whether systems, practices, and/or documents follow regulatory agency expectations and corporate expectations for regulatory submissions.The capability of developing plans to track documentation creation, review, revision, and archival and to communicate with interested parties is required.Provides CMO documents that affect the regulatory submission status and transfer of brand products among BI facilities and/or 3rd party product facilities.Provides input into decisions for systems and processes related to launch and filing process for brand products.Role has a high degree of autonomy in making decisions without involvement of supervisor.
B.S. degree in Chemistry, Pharmacy, or related scientific discipline plus a minimum of five (5) years’ experience in Analytical Chemistry in the Pharmaceutical Industry.
M.S. degree in Chemistry, Pharmacy, or related scientific discipline plus a minimum of four (4) years’ experience in Analytical Chemistry in the Pharmaceutical Industry.
Ph.D. degree in Chemistry, Pharmacy, or related scientific discipline plus a minimum of three (3) 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.)Knowledge and experience with Analytical Method Development, Validation and Transfer (for API and/or DP) in the pharmaceutical industry under applicable regulatory guidelines.Demonstrated technical knowledge and experience in the operation of key analytical instrumentation (HPLC, GC, Dissolution, Particle Size Analyzers, etc.) in the analysis of multiple pharmaceutical dosage forms, APIs, and excipients.Demonstrated ability to define and initiate project plans and drive milestones.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.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, Track Wise, or other data systems is preferred.Organizational skills and ability to influence and manage the execution of project milestones.Must have the ability to work without supervision using scientific judgment and scientific competency for both for strategic decisions and tasks of high complexity.Exercises latitude in determining objectives and approaches to assignments.Demonstrated ability to be an active participant on teams of high complexity, and to lead/facilitate teams on tasks of high complexity.Skills to effectively educate colleagues on technical principles, analytical fundamentals, etc. (e.g., explaining analytical details at meetings).Moderate ability to coach and or mentor both in and out of reporting structure (e.g., scientist levels I or II, or others).Minimum of five (5) years combination of quality, production, regulatory (chemistry, manufacturing, and control) and/or laboratory experience, with demonstrated accomplishments in effectively implementing cGMP requirements; QA pharmaceutical experience preferred. Technical writing experience within the pharmaceutical industry is preferred.Knowledge of pharmaceutical regulatory and compliance environment.Extensive knowledge and understanding of applicable laws and regulations regarding development and validation of analytical methods, including cGMP, DEA, and FDA guidance.Knowledge and understanding of US and international filing regulations and documentation content and forms, BI corporate procedures regarding submission documentation, and BI GMD requirements is preferred. Demonstrated ability to effectively apply cGMP and quality systems regulations within the pharmaceutical industry. Demonstrated knowledge of Quality Assurance, Production, and Regulatory Compliance functions within a pharmaceutical production environment is preferred.Organizational skills and ability to influence and manage the execution of project milestones.Must have the ability to work without supervision using scientific judgment and scientific competency for both for strategic decisions and tasks of high complexity.Exercises latitude in determining objectives and approaches to assignments.Demonstrated ability to be an active participant on teams of high complexity, and to lead/facilitate teams on tasks of high complexity.
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 againstCOVID-19or have an approved medical or religious accommodation. Clickherefor more information on the vaccine mandate andCOVID-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.