SR Principal Expert, Pharmaceutical Development and Technology, New Brunswick NJ - Boehringer Ingelheim
Saint Joseph, MO
About the Job
Description
+ The incumbent will support pharmaceutical technical activities and project management in the scientific areas of formulation, process and analytical development, scale-up, regulatory, and technology transfer of pharmaceutical oral, semi-solid, injectables dosage forms in a regulated manufacturing environment.
+ Be the "go to" technical expert for Global MSAT and Operations leadership for BIAH products and processes for analysis and guidance throughout product / process lifecycle
+ Provide guidance and influence decisions on new technologies to support future definition of innovative manufacturing platforms
+ Lead development, maintenance and advancement of technical body of knowledge for BIAH products and processes
+ Execute independent technical deliverables and projects and appropriately sized cross-functional technical projects as Project Leader, Stream Leader, Project Contributor or Program Leader
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.
Preferred location is New Brunswick NJ, but open to an individual located in Saint Joseph, MO or Duluth, GA.
Duties & Responsibilities
+ Be the "go to" technical expert for Global MSAT and Operations leadership for BIAH products and processes for analysis and guidance throughout product / process method lifecycle
+ Responsibilities include:
+ Provide technical guidance for change requests autonomously
+ Analyze complex process / product data to a higher-order and prepare reports autonomously for decision making
+ Provide 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 goods
+ Provide guidance and influence decisions on new technologies to support future definition of innovative manufacturing platforms
+ Responsibilities include:
+ Lead scientific exploration on existing BIAH technologies to guide definition of Technology Standards
+ Authoring of technical Position Papers for MSAT Organization
+ Recommend and advocate “as expert voice” for on new technologies for potential use in existing or new manufacturing processes
+ Recommend and advocate “as expert voice” for future-oriented Technology Platforms
+ Lead development, maintenance and advancement of technical body of knowledge for BIAH products and processes
+ Responsibilities include:
+ Continually develop and maintain an appropriate individual level of theoretical and practical expertise to respond to the needs of BIAH
+ Lead 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 BIAH
+ Lead and advance product / process knowledge within global and local MSAT teams
+ Execute independent technical deliverables and projects and appropriately sized cross-functional technical projects as Project Leader, Stream Leader, Project Contributor or Program Leader
+ Responsibilities include:
+ Operations Lead (by topic) of CMC Development sub-team
+ Technical 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 lifecycle
Requirements
+ Ph.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; Or
+ Masters 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 organization
+ Additional qualification in Business (Supply Chain, Economics) preferred
+ Professional Certification in Scientific field or Project Management preferred
+ Expertise in novel technologies or sciences is an advantage
+ Specialized 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 products
+ Thorough understanding and process knowledge of Pharmaceutical Quality System within BIAH
+ Thorough understanding and technical application of Good Manufacturing Practice (GMP) regulations and regulatory guidance for industry
+ Technical “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 processes
+ Leading AH Global Supply User Requirements driving effective and achievable AHGI deliverables
+ Responsible and accountable for communication of technical information for varied audiences
+ Demonstrated leadership, influence, and people development in international/intercultural collaboration
+ Experience and leadership in Agile Management preferred
+ Demonstrated leadership and influence through communications and truly engaging diverse audiences, within and cross organizations and from individual contributor to leadership levels
+ Proven and demonstrated specialized/depth of knowledge and leadership in identified discipline
+ Proven leadership and mentoring of Experts and influence on peers
+ Fluency in English required – additional language skills are an asset
+ Willingness to travel domestically and internationally
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.
+ The incumbent will support pharmaceutical technical activities and project management in the scientific areas of formulation, process and analytical development, scale-up, regulatory, and technology transfer of pharmaceutical oral, semi-solid, injectables dosage forms in a regulated manufacturing environment.
+ Be the "go to" technical expert for Global MSAT and Operations leadership for BIAH products and processes for analysis and guidance throughout product / process lifecycle
+ Provide guidance and influence decisions on new technologies to support future definition of innovative manufacturing platforms
+ Lead development, maintenance and advancement of technical body of knowledge for BIAH products and processes
+ Execute independent technical deliverables and projects and appropriately sized cross-functional technical projects as Project Leader, Stream Leader, Project Contributor or Program Leader
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.
Preferred location is New Brunswick NJ, but open to an individual located in Saint Joseph, MO or Duluth, GA.
Duties & Responsibilities
+ Be the "go to" technical expert for Global MSAT and Operations leadership for BIAH products and processes for analysis and guidance throughout product / process method lifecycle
+ Responsibilities include:
+ Provide technical guidance for change requests autonomously
+ Analyze complex process / product data to a higher-order and prepare reports autonomously for decision making
+ Provide 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 goods
+ Provide guidance and influence decisions on new technologies to support future definition of innovative manufacturing platforms
+ Responsibilities include:
+ Lead scientific exploration on existing BIAH technologies to guide definition of Technology Standards
+ Authoring of technical Position Papers for MSAT Organization
+ Recommend and advocate “as expert voice” for on new technologies for potential use in existing or new manufacturing processes
+ Recommend and advocate “as expert voice” for future-oriented Technology Platforms
+ Lead development, maintenance and advancement of technical body of knowledge for BIAH products and processes
+ Responsibilities include:
+ Continually develop and maintain an appropriate individual level of theoretical and practical expertise to respond to the needs of BIAH
+ Lead 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 BIAH
+ Lead and advance product / process knowledge within global and local MSAT teams
+ Execute independent technical deliverables and projects and appropriately sized cross-functional technical projects as Project Leader, Stream Leader, Project Contributor or Program Leader
+ Responsibilities include:
+ Operations Lead (by topic) of CMC Development sub-team
+ Technical 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 lifecycle
Requirements
+ Ph.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; Or
+ Masters 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 organization
+ Additional qualification in Business (Supply Chain, Economics) preferred
+ Professional Certification in Scientific field or Project Management preferred
+ Expertise in novel technologies or sciences is an advantage
+ Specialized 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 products
+ Thorough understanding and process knowledge of Pharmaceutical Quality System within BIAH
+ Thorough understanding and technical application of Good Manufacturing Practice (GMP) regulations and regulatory guidance for industry
+ Technical “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 processes
+ Leading AH Global Supply User Requirements driving effective and achievable AHGI deliverables
+ Responsible and accountable for communication of technical information for varied audiences
+ Demonstrated leadership, influence, and people development in international/intercultural collaboration
+ Experience and leadership in Agile Management preferred
+ Demonstrated leadership and influence through communications and truly engaging diverse audiences, within and cross organizations and from individual contributor to leadership levels
+ Proven and demonstrated specialized/depth of knowledge and leadership in identified discipline
+ Proven leadership and mentoring of Experts and influence on peers
+ Fluency in English required – additional language skills are an asset
+ Willingness to travel domestically and internationally
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.
Source : Boehringer Ingelheim