Scientist IV, Analytical Development

Boehringer Ingelheim • Saint Joseph, MO

2d

About The Position

The Scientist IV, Analytical Development designs and executes experiments to develop robust, scalable, and transferable analytical methods for biological active ingredients and final products. The role develops and supports in-process testing for biological development and release testing for final products, and provides technical and communication leadership as a functional representative on R&D biological project core teams. The scientist also provides early-development guidance to Research projects and identifies and implements innovative analytical technologies.

The position develops, optimizes, qualifies, validates, and transfers analytical methods; establishes analytical control strategies for biological products and manufacturing processes; and supports product characterization, process development, comparability assessments, technology transfers, and regulatory submissions. It applies modality-specific analytical approaches to assess product identity, purity, potency, aggregation, molecular integrity, and stability, and serves as a technical subject matter expert for characterization strategies supporting vaccine and biologic platforms.

The role independently conducts routine and challenging procedures and exploratory experiments, interprets and reports data with integrity, and presents scientific findings and recommendations to project teams and leadership. It provides technical guidance and training to junior scientists, technicians, and laboratory personnel; collaborates across Research, Development, Clinical, Regulatory, Quality, and Operations; and complies with applicable regulations, safety practices, SOPs, and recordkeeping policies.

Requirements

• PhD from an accredited institution and two years of experience in a related scientific discipline; or a master's degree and at least six years of related experience; or a bachelor's degree and at least ten years of experience in a related field.
• Research methodology experience and education.
• Advanced training in the area of technical expertise and demonstrated knowledge of the field.
• Expertise in the biologicals/pharmaceutical lifecycle process.
• Thorough understanding of USDA and EMEA regulatory requirements.
• Demonstrated project management skills.
• Demonstrated expertise in nucleic acid characterization, PCR, qPCR, RT-qPCR, digital PCR, sequencing-based technologies, nucleic acid extraction, quantitation, and integrity assessment.
• Experience in molecular assay development, qualification, validation, and transfer.
• Expertise with ELISA, Western blot/immunoblot, antigen quantification assays, antibody characterization assays, potency assays, and identity assays.
• Hands-on experience with SDS-PAGE, CE-SDS, densitometry, SEC-HPLC, aSEC, aCEX, and related chromatographic and electrophoretic methods.
• Demonstrated analytical development and characterization experience supporting biological product modalities.
• 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 at least 18 years of age.

Responsibilities

• Design, execute, interpret, troubleshoot, and complete routine and non-routine scientific procedures independently.
• Initiate and conduct exploratory experiments and propose new experimental designs.
• Develop, optimize, qualify, validate, and transfer analytical methods for characterization, in-process, release, and stability testing.
• Establish analytical control strategies for biological products and manufacturing processes across diverse product modalities and lifecycle stages.
• Support product characterization, process development, comparability assessments, technology transfers, and regulatory submissions.
• Apply analytical approaches to assess identity, purity, potency, aggregation, molecular integrity, and stability.
• Present scientific data and recommendations to project teams and leadership, and communicate and defend work orally and in writing.
• Provide technical guidance and training to junior scientists, technicians, and laboratory personnel.
• Propose, evaluate, and implement ideas and new technologies based on scientific and technical knowledge.
• Conduct literature searches, attend scientific meetings, and keep abreast of developments in the field.
• Collaborate across Research, Development, Clinical, Regulatory, Quality, and Operations, and participate in cross-departmental project teams when assigned.
• Prepare technical reports, publications, and oral presentations.
• Maintain data integrity and ethics, comply with applicable regulations and safe work practices, and maintain records in accordance with SOPs and policies.
• Act as a leader in the absence of the supervisor.

Benefits

• Competitive compensation and benefit programs.
• Support for a healthy working environment, meaningful work, mobility, networking, and work-life balance.
• Opportunities to collaborate internationally and contribute directly to company success.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree