Scientist IV, Infrastructure Analytical Development
The basic purpose for the role of the Scientist IV is to work within a team in Analytical Development to support global innovation and product development. The role involves management of stability studies, raw material qualification (both internally and externally), reference standard qualification, performing key-user roles in digitization platforms, and improving internally established processes in terms of quality culture, good documentation practices, and GxP compliance.
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:
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Stability management according to ICH/VICH guidelines
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Establish, maintain, and also continuously optimize a robust, efficient, and compliant stability program to enable the product development teams to conduct fit-for-purpose stability studies in the most efficient way possible
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Maintain the stability chamber inventory with robust tracking mechanism to ensure the chain of custody of the stability samples
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Proficiency in Labware Laboratory Information Management System (LIMS)
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Setup and manage product LIMS specifications for data entry purpose.
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Setup and manage stability studies and creation of stability reports in formats that meet various stakeholder requirements.
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Setup and manage sample entries; creation and approval of certificate of analyses
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Raw Material Qualification Management
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Work with other functions such as Formulation Development, Late Stage Drug Product Development, and Quality Assurance to establish, maintain, and also continuously optimize a robust, efficient, and compliant raw material ordering, receiving, sampling, testing, and creation and approval of certificate of analyses, to facilitate the product development teams to use the raw materials for product development and for clinical trials.
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Setup CROs for raw material testing (request quotes, create purchase orders, ship samples, first line of communication for investigations, manage documents and results received from CRO, follow through and follow-up for closure of pending activities, etc.)
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Perform internal raw material qualification with compendial or in-house analytical methods, as needed (e.g. wet chemistry, Karl Fischer, HPLC/GC, IR, and other modern analytical technologies).
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Reference Standard Qualification Management
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Establish a fit-for-purpose reference standard qualification program for NBRC internal product
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Perform reference standard characterization and periodic qualification with compendial or in-house analytical methods, as needed
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Work with other functions such as LSDPD and Global Supply to re-distribute responsibility of managing reference standard qualification and recertification
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Implementation and maintenance of Digitization Platforms
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GSpecs Cloud Platform for specification documentation
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LabWare Laboratory Information Management System (LIMS)
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Electronic Laboratory Notebook (ELN)
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Empower® Chromatography Data System (CDS)
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Boehringer Ingelheim Regulatory Documents for Submission (BIRDS)
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Computer Systems and Metrology Coordination
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Instrument/software qualification review
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Coordination with Site Operations and other functions for repairs, routine PM/Cal, etc.
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Quality Culture and GxP Compliance
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Implementation of appropriate laboratory practices (GSP, GMP, GLP, GDP, etc.)
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Scientist training and qualification
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Good Documentation Practices (including ELN for GxP usage)
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Standard Operating Procedure updates
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Requirements:
- PhD (or equivalent) in chemistry field with at least 2+ years in pharmaceutical product development with a good understanding of the details of the workflow.
- Or M.Sc. (or equivalent) in chemistry field with at least 6+ years in pharmaceutical product development with a good understanding of the details of the workflow.
- Or BSc (or equivalent) in chemistry field with at least 9+ years in pharmaceutical product development with a good understanding of the details of the workflow.
- Proficiency with computer-based systems (Microsoft Office, MS Teams/SharePoint, LIMS, ELN, etc.) and ability to learn software systems quickly.
- Experience with LabWare LIMS system is highly preferred.
- In-depth knowledge of GLP/cGMP regulations and ICH/VICH guidelines, compendia monographs/methods, and pharmaceutical development process.
- In-depth knowledge of compendial testing (USP-NF, Ph. Eur., etc.) in a GxP environment.
- Previous experience in comprehensive analytical laboratory for USP-NF, EP, Monograph testing.
- Exceptional organizational skills with a quality orientation.
- Strong interpersonal skills and communication skills.
- Ability to troubleshoot and solve scientific and/or technical challenges.
- Possesses a customer service orientation, delivering results, and executing in a fast and focused manner.
- Skilled in conflict resolution.
- Capability to deal with variety of challenging matters including setbacks and failures.
- Strong quality mindset.
- Ability to identify opportunities and implement solutions for continuous improvement within scope of our routine processes.
- Need to be compliant with legislative expectations of regulatory agencies as well as the BI Quality Organization
- Demonstrated project management skills.
- Plan and conduct scientific/laboratory experiments and evaluate and interpret data.
- Provide training and guidance to laboratory personnel.
- Prepare technical reports, publications and oral presentations.
- Act as a leader in absence of supervisor.
- Appropriate level of understanding of applicable regulations.
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.
- This position will require individuals to be fully vaccinated against COVID-19 or have an approved medical or religious accommodation. Click here for more information on the vaccine mandate and COVID-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.
Want to learn more? Visit boehringer-ingelheim.com and join us in our effort to make more health.
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.
