Scientist IV, Analytical Development

Boehringer Ingelheim • Saint Joseph, MI

4d

About The Position

Designs and executes experiments to develop robust, scalable, transferable analytical methods for biological active ingredients and final products. Develops and supports in-process testing for biological development and release tests for final products. Serves in technical and communication roles for the function on Research & Development (R&D) new biological project core teams, provides early development guidance to Research projects, and identifies and implements innovative analytical technology.

The position supports the discovery, development, and delivery of products and involves collaboration across Research, Development, Clinical, Regulatory, Quality, and Operations. It provides technical expertise in analytical development and characterization for biological products, vaccines, and biologic platforms throughout the product lifecycle, including support for process development, comparability assessments, technology transfers, and regulatory submissions.

Requirements

• PhD from an accredited institution and two years of experience in a related scientific discipline; or a master's degree from an accredited institution and at least six years of related scientific experience; or a bachelor's degree from an accredited institution and at least ten years of experience in a related field.
• Research methodology experience and education.
• Advanced training in the area of technical expertise.
• Demonstrated knowledge of the field.
• Expertise in the biologicals/pharmaceutical life-cycle process.
• Thorough understanding of USDA and EMEA regulatory requirements.
• Demonstrated project management skills.
• Appropriate level of understanding of applicable regulations.
• 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.

Nice To Haves

• Demonstrated expertise in nucleic acid characterization, PCR, qPCR, RT-qPCR, digital PCR, sequencing-based technologies, nucleic acid extraction, quantitation, integrity assessment, and molecular assay development, qualification, validation, and transfer.
• Extensive experience developing, optimizing, qualifying, validating, and transferring analytical methods and establishing analytical control strategies for biologics and vaccines.
• 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.

Responsibilities

• Initiate, design, interpret, troubleshoot, and complete routine procedures independently and efficiently, and conduct non-routine and difficult procedures without supervision.
• Initiate and conduct exploratory experiments.
• 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, including strategies appropriate for diverse modalities throughout the product lifecycle.
• Present scientific data and recommendations to project teams and leadership.
• Provide technical guidance and training to junior scientists, technicians, and laboratory personnel.
• Propose, gain support for, and implement ideas based on scientific and technological knowledge and understanding of the drug discovery process.
• Propose, evaluate, and implement new technologies; apply scientific principles, conduct literature searches, attend scientific meetings, and stay current with relevant literature.
• Communicate and defend work orally and in writing in the context of company and team goals.
• Maintain technical proficiency and train technicians and junior scientists in the field.
• Report and treat data with a high level of integrity and ethics.
• Comply with applicable regulations and safety practices, and maintain records according to Standard Operating Procedures (SOPs) and policies.
• Participate in cross-departmental project teams when assigned.
• Apply an understanding of USDA, EMA, VICH, and applicable regulatory requirements for veterinary biological products.
• Support product characterization, process development, comparability assessments, technology transfers, and regulatory submissions.
• Apply modality-specific analytical approaches to assess identity, purity, potency, aggregation, molecular integrity, and stability.
• Serve as a technical subject matter expert for characterization strategies supporting novel and established vaccine and biologic platforms.
• Propose experimental designs, conduct probing experiments, plan and conduct scientific and laboratory experiments, and evaluate and interpret data.
• Prepare technical reports, publications, and oral presentations.
• Act as a leader in the absence of a 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, with visibility and opportunities to contribute to company success.

What This Job Offers

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