Senior Scientist - Drug Metabolisma and Pharmacokinetics

Description

Boehringer Ingelheim is seeking an enthusiastic, creative, and highly motivated Bioanalytical Liquid Chromatography-Mass Spectrometry (LCMS) Senior Scientist to join the Bioanalytical Sciences group in Drug Metabolism & Pharmacokinetics (DMPK) at our US headquarters in Ridgefield, CT.

The main responsibilities of the Senior Scientist include independently developing, troubleshooting, and validating GLP/GCP bioanalytical LCMS methods with minimal or no supervision, investigation and implementation of new technologies, training and mentoring of junior scientists, monitoring of outsourced bioanalytical work, and may include DMPK representation on multi-disciplinary project teams. Work must be performed in compliance with applicable regulatory and safety guidelines. The scope of responsibility is within the primary discipline of LCMS bioanalysis with opportunities to branch into other areas including immunoassays and applications involving novel scientific approaches.

The Bioanalytical Sciences group conducts routine and non-routine assessments of drug concentration measurement (PK) and anti-drug antibody (ADA) analysis of protein-based drugs using both customary and state of the art platforms, and manages nonclinical and clinical PK and ADA bioanalytical work at CROs.

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 a number of 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.
 

Duties & Responsibilities

• Develop and validate bioanalytical LCMS methods to measure protein-based drug concentrations in animals and humans following regulatory guidances and industry practices, as applicable.
• Monitor, both internally and at CROs, method transfer, troubleshooting, validation, and sample analysis from non-clinical and clinical studies in compliance with regulatory requirements (GLP/GCP).
• Propose, gain support for, and implement new ideas and technologies from individual’s knowledge of science and technology and understanding of drug discovery and development process.
• Initiate, design, interpret, troubleshoot, and complete routine procedures independently and efficiently; Conduct exploratory experiments with minimal to no supervision.
• Effectively communicate and defend own work, orally and in writing; contribute to technical reports and presentations and author protocols and procedures with minimal supervision.
• Perform literature searches, attend scientific meetings, and keep abreast of literature in own field; author posters and manuscripts and provide presentations at external conferences.
• Potentially serve as a DMPK representative on multi-disciplinary project teams.

Requirements

• Ph.D. Degree or equivalent experience in Immunology, Cell Biology, Biochemistry, Chemistry, or a related field with at least 2 years of experience in immunoaffinity LC-MS workflows for therapeutic proteins.
• Pharmaceutical, biotechnology or CRO experience is highly desirable.
• Experience in a GLP/GCP environment developing, troubleshooting, and validating (according to regulatory requirements) immunoaffinity LCMS workflows for therapeutic proteins including mAbs, ADCs, and bispecifics is highly desirable.
• Experience with high resolution mass spectrometry is highly desirable.
• Experience in performing scientific oversight of outsourced bioanalysis to CROs.
• Excellent written and verbal communication skills and ability to draft technical reports, presentations, posters, and manuscripts.
• Ability and willingness to work effectively in a highly collaborative environment to solve problems.

Compensation Data

This position offers a base salary typically between $140,000.00 and $222,000.00 USD.  The position may be eligible for a role specific variable or performance based bonus and or other compensation elements.  For an overview of our benefits please click here.

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