SENIOR PRINCIPAL EXPERT - PHARMACEUTICAL DEVELOPMENT AND TECHNOLOGY (MULTIPLE LOCATIONS)

DescriptionBe the go to technical expert for Global MSAT and Operations leadership for BIAH products and processes for analysis and guidance throughout product / process lifecycleProvide guidance and influence decisions on new technologies to support future definition of innovative manufacturing platformsLead development, maintenance and advancement of technical body of knowledge for BIAH products and processesExecute independent technical deliverables and projects and appropriately sized cross-functional technical projects as Project Leader, Stream Leader, Project Contributor or Program LeaderAs 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.Locations include: New Brunswick NJ, Saint Joseph, MO or Duluth, GA.Duties & ResponsibilitiesBe the go to technical expert for Global MSAT and Operations leadership for BIAH products and processes for analysis and guidance throughout product / process method lifecycleResponsibilities include:Provide technical guidance for change requests autonomouslyAnalyze complex process / product data to a higher-order and prepare reports autonomously for decision makingProvide technical leadership, guidance and influence on processes and strategies for troubleshooting, root cause analysis and execution of technical transfer, manufacturing deviations, validations, analytical tests, etc. Provide technical leadership and guidance for questions received from Regulatory Authorities in various regulatory processes, e.g. geographical expansion of existing products, post approval changes on existing registrations. Lead strategy development and deployment of technical solutions for process optimization/ improvement of analytical test methods with possible impact on cost of goodsProvide guidance and influence decisions on new technologies to support future definition of innovative manufacturing platformsResponsibilities include:Lead scientific exploration on existing BIAH technologies to guide definition of Technology StandardsAuthoring of technical Position Papers for MSAT OrganizationRecommend and advocate “as expert voice” for on new technologies for potential use in existing or new manufacturing processesRecommend and advocate “as expert voice” for future-oriented Technology PlatformsLead development, maintenance and advancement of technical body of knowledge for BIAH products and processesResponsibilities include:Continually develop and maintain an appropriate individual level of theoretical and practical expertise to respond to the needs of BIAHLead MSAT mentorship program and mentor MSAT experts in experiential technical and transferrable knowledge growth Lead exchange program of Technology expertise across global and local MSAT teams Participate as active and influential member of industry working groups representing BIAHLead and advance product / process knowledge within global and local MSAT teamsExecute independent technical deliverables and projects and appropriately sized cross-functional technical projects as Project Leader, Stream Leader, Project Contributor or Program LeaderResponsibilities include:Operations Lead (by topic) of CMC Development sub-teamTechnical guidance and recommendation for user requirements, product or process changes Develop, structure and lead cross-functional streams / projects / programs aligned with project management methodology Propose and manage scope, budget, schedule, and associated risks to deliver fully-functional deliverables / projects meeting Customer requirements Ensure compliance to regulatory requirements and BI / external standards (EHS, VICH, Corporate procedures, GxP etc.) Establish & maintain communication tools (e.g. project charter, monthly reports) to effectively communicate with all relevant stakeholders Ensure and measure customer satisfaction along the project lifecycleRequirementsPh.D. from an accredited institution in scientific discipline (Pharmacy, Chemistry, Biochemistry, Biological sciences preferred) with a minimum of five (5) years of direct industry experience; OrMasters degree from an accredited institution in scientific discipline (Pharmacy, Chemistry, Biochemistry, Biological sciences preferred) with a minimum of ten (10) years of direct industry experience; Or Bachelor's degree from an accredited institution in scientific discipline (Pharmacy, Chemistry, Biochemistry, Biological sciences preferred) with a minimum of fourteen (14) years of direct industry experience Experience must be inclusive of at least three (3) years of experience leading, influencing and developing people across the organizationAdditional qualification in Business (Supply Chain, Economics) preferred Professional Certification in Scientific field or Project Management preferred Expertise in novel technologies or sciences is an advantageSpecialized depth of knowledge and extensive industry experience in one or more of the following areas: manufacturing sciences, manufacturing engineering, product formulation, material science and analytical testing methodologies of pharmaceuticals or biologicals productsThorough understanding and process knowledge of Pharmaceutical Quality System within BIAHThorough understanding and technical application of Good Manufacturing Practice (GMP) regulations and regulatory guidance for industryTechnical “how to” guidance, application and approach influence on data & information for CMC, product manufacture & delivery (e.g. manufacturing processes, quality, supply chain & risk management)Thorough understanding and influence on new product development and product lifecycle management processesLeading AH Global Supply User Requirements driving effective and achievable AHGI deliverablesResponsible and accountable for communication of technical information for varied audiencesDemonstrated leadership, influence, and people development in international/intercultural collaborationExperience and leadership in Agile Management preferredDemonstrated leadership and influence through communications and truly engaging diverse audiences, within and cross organizations and from individual contributor to leadership levelsProven and demonstrated specialized/depth of knowledge and leadership in identified disciplineProven leadership and mentoring of Experts and influence on peersFluency in English required – additional language skills are an assetWillingness to travel domestically and internationally