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.
The Senior Expert, Manufacturing Science and Technology will support BIAH products and processes with specialized technical analysis and recommendation throughout product / process life cycle. This role will explore and research new technologies to support future definition of innovative manufacturing platforms. The incumbent will support development and maintenance of technical body of knowledge for BIAH products and processes.
The Senior Expert, Manufacturing Science and Technology will execute independent technical deliverables and appropriately sized technical projects as Project Leader, Subject Matter Expert or Project Contributor.
Duties & Responsibilities
Support BIAH products and processes with specialized technical analysis and recommendation throughout product / process life cycle:
Evaluates & approves minor/moderate change requests autonomously; assesses major change requests and provides recommendation for approval.
Analyzes process / product data and prepares reports in support of project.
Provides troubleshooting, root cause analysis and technical guidance for technical transfers, 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 of analytical test methods with possible impact on cost of goods.
Explore, research, and assess technologies to support future definition of innovative manufacturing platforms:
Researches and analyzes existing BIAH technologies to support definition of Technology Standards.
Researches, assesses, and trends internal / external data sources to support Expert Position Papers.
Investigates and assesses new technologies for potential use in existing or new manufacturing processes.
Assists Scientists and other Subject Matter Experts in developing future-oriented Technology Platforms.
Support development and maintenance of 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.
Facilitates exchange of Technology expertise across global and local Manufacturing and Science Technology teams.
Captures and maintains ongoing product / process knowledge within global and local Manufacturing Science and Technology teams.
Execute independent technical deliverables and appropriate size/complexity technical projects as Project Leader, Subject Matter Expert or Project Contributor:
Provides support to Operations Lead of CMC Development sub-team.
Technical assessment of user requirements, product or process changes.
Develops, structures, and leads cross-functional streams / projects 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 & 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 one (1) year direct industry experience.
OR
Master's degree in scientific discipline (Pharmacy, Chemistry, Biochemistry, Biological sciences preferred) with a minimum of three (3) years direct industry experience.
OR
Bachelor's degree in scientific discipline (Pharmacy, Chemistry, Biochemistry, Biological sciences preferred) with a minimum of five (5) years direct industry experience.
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.
Intense willingness to develop technical expertise at bench and production scale.
Ability to communicate in English required - additional language skills are an asset.
Willingness to travel domestically and internationally.
Strong interest for international/intercultural collaboration.
Training and experience in Agile Management preferred.
Ability to adapt communications and truly engage with diverse audiences.
Proven specialized/depth of knowledge 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.
