Senior Scientist, Drug Metabolism and Pharmacokinetics – Bioanalysis Full-time NEW

Biotherapeutic Immunoassay Senior Scientist

Boehringer Ingelheim is seeking an enthusiastic, creative and highly motivated Biotherapeutic Immunoassay Senior Scientist to join the Bioanalytical Sciences group in Drug Metabolism & Pharmacokinetics (DMPK) at our US headquarters in Ridgefield, CT. 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, viral products, and oligonucleotides, and manages nonclinical and clinical PK and ADA bioanalytical work at CROs. The Bioanalytical Sciences group actively characterizes critical reagents used in PK and ADA bioanalyses and conducts investigative experiments to support the interpretation of complex PK and ADA results. All of this work uses both customary and state of the art platforms. As such, this role would also include investigation and implementation of new technologies. The main responsibilities of the Senior Scientist include: independently developing, troubleshooting, and validating GLP/GCP bioanalytical immunoassay methods with minimal or no supervision, investigation and implementation of new technologies, training/mentoring of junior scientists, monitoring of outsourced bioanalytical work, and may include DMPK representation on project teams. Work must be performed in compliance with applicable regulatory and safety guidelines. The scope of responsibility is within the primary discipline of bioanalysis with opportunities to branch into other areas including cell based immunoassays and applications involving novel scientific approaches.

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

• Initiate, design, interpret, troubleshoot and complete routine procedures independently and efficiently; Conduct exploratory experiments with minimal to no supervision. May direct and oversee experimental design and results of technicians and junior level scientists
• Manage multiple bioanalytical projects supported both internally and at CROs.
• Develop and validate bioanalytical methods to measure drug concentrations and anti-drug antibodies in animals and humans following regulatory guidances and industry practices, as applicable.
• Analyze samples from non-clinical and clinical studies in compliance with regulatory requirements (GLP/GCP).
• Serve as the Scientific Monitor for both nonclinical and clinical PK and ADA method transfer, troubleshooting, validation, and sample analysis.
• 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.
• Develops an understanding of R&D team goals and works effectively toward achieving them; Either assumes departmental responsibility for projects when necessary 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; Presents responsibly and defends own work at meetings; May deliver updates to senior level management in context of overall project goals
• Plan and conduct laboratory work and document technical data according to Standard Operating Procedures. Report and treat data with a high level of integrity and ethics.
• Develops expertise in a specific project-relevant area or technology; May provide guidance and expertise to advance specific projects or evaluate and propose new technologies and concepts in support of multiple projects; Ability to work with various LIMS; Compilation of associated outputs with supervision
• Keeps abreast of relevant literature; author posters and manuscripts and provide presentations at external conferences.
• Develops visibility outside of functional area and authors protocols and procedure with minimal supervision
• 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 experience in a related field
• Demonstrates a broad knowledge of field
• Appropriate level of understanding of applicable regulations
• Ability to communicate effectively both orally and in writing in an interdisciplinary environment Ph.D. or equivalent experience in a related field
• Proficient in developing, troubleshooting, and validating (according to regulatory requirements) ligand binding immunoassays
• Proven problem solving ability.
• Ability to operate and maintain laboratory equipment with independence.
• Excellent written and verbal communication skills and ability to draft technical reports, presentations, posters, and manuscripts.
• Proficiency with computers and data analysis software.
• Ability and willingness to work effectively in a highly collaborative environment.

Desired Skills, Experience and Abilities

• Ph.D. with 2+ years experience, Master's Degree with 8+ years experience or Bachelor's Degree with 12+ years experience in related scientific discipline.
• Pharmaceutical, biotechnology or CRO experience
• Experience working in a GLP/GCP environment
• Experience with other platforms such as Gyrolab, Singulex, Quanterix, MSD-based immunoassays, or qPCR
• Experience in performing scientific oversight of outsourced bioanalysis to CROs