Senior Scientist, Drug Metabolism and Pharmacokinetics - Bioanalysis

Compensation DataThe base salary range for this position is $140,000.00 to $222,000.00 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.DescriptionBoehringer 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 managesnonclinical 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 & ResponsibilitiesInitiate, 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 scientistsManage 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 analysisPropose, gain support for and implement new ideas and technologies from individual’s knowledge of science and technology and understanding of drug discovery and development processDevelops 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 goalsPrepares 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 goalsPlan and conduct laboratory work and document technical data according to Standard Operating Procedures. Report and treat data with a high level of integrity and ethicsDevelops 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 supervisionKeeps abreast of relevant literature; author posters and manuscripts and provide presentations at external conferencesDevelops visibility outside of functional area and authors protocols and procedure with minimal supervisionAssumes responsibility for direct reports as needed including recruiting, managing, mentoring and developing scientific staffComplies 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 policiesContributes to departmental administration; Demonstrates fiscal responsibility with respect to cost of experiments, technology, external collaborations, and travelRequirementsPh.D. Degree or equivalent experience in a related fieldDemonstrates a broad knowledge of fieldAppropriate level of understanding of applicable regulationsAbility to communicate effectively both orally and in writing in an inter disciplinary environment Ph.D. or equivalent experience in a related fieldProficient in developing, troubleshooting, and validating (according to regulatory requirements) ligand binding immunoassaysProven problem solving abilityAbility to operate and maintain laboratory equipment with independenceExcellent written and verbal communication skills and ability to draft technical reports, presentations, posters, and manuscriptsProficiency with computers and data analysis softwareAbility and willingness to work effectively in a highly collaborative environment. Desired Skills, Experience And AbilitiesPh.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 environmentExperience with other platforms such as Gyrolab, Singulex, Quanterix, MSD-based immunoassays, or qPCRExperience in performing scientific oversight of outsourced bioanalysis to CROsOur CompanyWhy Boehringer Ingelheim?With us, you can develop your own path in a company with a culture that knows our differences are our strengths - and break new ground in the drive to make millions of lives better.Here, your development is our priority. Supporting you to build a career as part of a workplace that is independent, authentic and bold, while tackling challenging work in a respectful and friendly environment where everyone is valued and welcomed.Alongside, you have access to programs and groups that ensure your health and wellbeing are looked after - as we make major investments to drive global accessibility to healthcare. By being part of a team that is constantly innovating, you'll be helping to transform lives for generations.Want to learn more? Visit https://www.boehringer-ingelheim.com