Description
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, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
As the Principal Expert, Manufacturing Science & Technology, the incumbent will be the "go to" technical expert for Global MSAT and Global Supply leadership for BIAH products and processes for analysis and guidance throughout product / process lifecycle and/or guidance to Global Innovation during new product development. The position holder will recommend new technologies to support future definition of innovative manufacturing platforms.
The Principal Expert, Manufacturing Science & Technology will facilitate, distill and integrate information into the technical/scientific body of knowledge for BIAH Global Supply products and processes, either for new product developments or product life cycle management. This role will execute independent technical deliverables and projects and appropriately sized cross-functional technical projects as Project Leader or Project Contributor.
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 and new product developments:
Evaluates and approves moderate and major change request autonomously.
Analyzes complex process / product data and prepares reports autonomously.
Provides troubleshooting, root cause analysis and scientific guidance autonomously for execution of technical transfer, manufacturing deviations, validations, analytical tests, etc.
Provides technical input and support for questions received from Regulatory Authorities in various regulatory processes, e.g. geographical expansion of existing products, post approval changes on existing registrations.
Develops technical solutions for process optimization/ improvement and evaluates possible impact on cost of goods.
Recommends new technologies to support future definition of innovative manufacturing platforms:
Provides scientific guidance on existing BIAH technologies to guide definition of Technology Standards.
Provides support of technical Position Papers for MSAT Organization.
Autonomously seeks out new technologies for potential use in existing or new manufacturing processes.
Autonomously researches and recommends future-oriented Technology Platforms.
Facilitates, distills, and integrates information into technical body of knowledge for BIAH products and processes:
Continually develops and maintains an appropriate individual level of theoretical and practical expertise to respond to the needs of BIAH.
Mentors MSAT experts in experiential technical and transferrable knowledge growth.
Leads exchange of Technology expertise across global and local MSAT teams.
Participates as active member of industry working groups representing BIAH.
Facilitates and distills ongoing product / process knowledge within global and local MSAT teams.
Executes independent technical deliverables and projects and appropriately sized cross-functional technical projects as Project Leader or Project Contributor:
Functions as surrogate and/or provides ad-hoc support to Global Supply Lead (by topic) of CMC Development sub-team.
Provides technical guidance and recommendation for user requirements, product or process changes.
Develops, structures, and leads cross-functional streams / projects / programs aligned with project management methodology.
Proposes and manages scope, budget, schedule, and associated risks to deliver fully functional deliverables / projects meeting Customer requirements.
Ensures compliance to regulatory requirements and BI / external standards (EHS, VICH, Corporate procedures, GxP etc.)
Establishes and maintains communication tools (e.g. project charter, monthly reports) to effectively communicate with all relevant stakeholders.
Ensures and measures customer satisfaction along the project lifecycle.
Requirements
Ph.D. in scientific discipline (Pharmacy, Chemistry, Biochemistry, Biological sciences preferred) with a minimum of three (3) years direct industry experience.
OR
Master's degree in scientific discipline (Pharmacy, Chemistry, Biochemistry, Biological sciences preferred) with a minimum of seven (7) years direct industry experience.
OR
Bachelor's degree in scientific discipline (Pharmacy, Chemistry, Biochemistry, Biological sciences preferred) with a minimum of ten (10) years direct industry experience.
Experience must be inclusive of at least one (1) years 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.
Demonstrated technical expertise at bench and production scale.
Fluency in English required - additional language skills are an asset.
Willingness to travel domestically and internationally.
Demonstrated international/intercultural collaboration.
Training and leadership in Agile Management preferred.
Demonstrated ability to adapt 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.
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.
Desired Skills, Experience and Abilities
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.