Principal Scientist, Drug Metabolism and Pharmacokinetics

Description

Boehringer Ingelheim is seeking an enthusiastic, creative and highly motivated Principal Scientist to join the neutralizing antibody (nAb) group in Drug Metabolism & Pharmacokinetics (DMPK) at our US headquarters in Ridgefield, CT. The main responsibility of this position is to develop cell based and competitive ligand binding assays to evaluate neutralization activity of anti-drug antibodies in clinical samples, in support of clinical immunogenicity assessments.

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

• Independently designs and performs scientific experiments with a predefined goal including developing new methodologies; Protocols and or test procedures that contribute to core group/research goals and reflect expert knowledge; Direct and oversee experimental designs and results of technicians and junior level scientists
• Serve as scientific monitor for assay performance and project management at external CROs.
• Contributes to defining R&D team goals and collaborates with scientists within and outside functional area in achieving them; Assumes departmental responsibility for projects or has ability to participate as representative on multiple project teams and contribute to defining expertise-related aspects of overall program goals
• Prepares clear technical reports, publications and oral presentations. Independently communicates results in the form of reports and or presentations; Delivers updates to senior level management in context of overall project goals
• Demonstrates an expertise in a specific project-relevant area or technology; Provides guidance and expertise to advance specific projects or evaluates and proposes new technologies and concepts in support of multiple projects
• Develops broad knowledge in field of expertise, including the ability to interpret current literature relevant to R&D projects, and visibility outside of functional area
• Assumes responsibility for direct reports as needed including recruiting, managing, mentoring and developing scientific staff
• Complies with all applicable regulations; Ensures that work performed in area of responsibility is conducted in a safe and compliant manner; Maintains proper records in accordance with SOPs and policies
• Contributes to departmental administration; Demonstrates fiscal responsibility with respect to cost of experiments, technology, external collaborations, and travel

Requirements

• Ph.D. Degree or equivalent with at least five (5+) years related experience in a related field; or equivalent
• At least three (3+) years direct hands-on experience developing, optimizing, and validating nAb assays for clinical sample analysis in a regulated bioanalytical environment
• Demonstrated experience conducting clinical nAb assay development, validation and sample analysis at a CRO, or directly overseeing and managing these activities at a CRO
• Demonstrated expertise in developing novel in vitro cell-based and ligand-binding immunoassays to support regulated bioanalytical testing for late-stage clinical studies (Phase III-IV)
• Demonstrated expertise in the validation of bioanalytical immunoassay methods for biologics, peptides, and advanced therapy medicinal products (ATMPs) in a regulated GLP/GCP environment
• Comprehensive knowledge of global regulatory guidance and industry best practices related to the development, validation, and application of bioanalytical immunoassays, with demonstrated experience applying these standards in support of clinical programs
• Demonstrated proficiency with multiple analytical platforms, including EnVision, SpectraMax, MSD, flow cytometry and related technologies
• Ability to independently operate, troubleshoot, and maintain laboratory instrumentation and equipment
• Strong scientific problem-solving, critical thinking, and decision-making skills
• Excellent oral, written, and presentation communication skills with the ability to communicate complex scientific concepts to diverse audiences
• Proven ability to work effectively as a collaborative team player within a matrixed, cross-functional environment
• Ability to build productive partnerships and communicate effectively across interdisciplinary teams, including research, clinical, regulatory, and external collaborators
• Appropriate level of understanding of applicable regulations
• Ability to communicate effectively both orally and in writing in an interdisciplinary environment

Compensation Data

The base salary range for this position is $140,800.00 to $211,200.00 USD.   The position may be eligible for a role specific discretionary bonus, relocation, and/or other compensation elements.  We continuously review market data and may adjust salary ranges as needed in the future.  Actual compensation will be based on job-related factors such as skills, experience, and qualifications, and other factors permitted by law. For an overview of our benefits please click here.