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The Associate Director, Bioanalysis is responsible for providing expertise in the areas of Ligand binding assay method development and sample analysis, representing Bioanalysis on the project team. Expertise in Mass Spectrometry, Ultra High-Performance Liquid Chromatography, plasma and tissue sample preparation, bioanalytical method development and validation are desirable, but not required. Conducts method development and sample analysis for pharmacokinetic, immunogenicity, human food safety, efficacy and safety studies to support the development of new products and the maintenance of existing products. Contributes to project and task force teams and functions as Study Director or Sponsor Representative for BIAH studies. Responsible for the generation and interpretation of scientific data leading to a better understanding of the pharmacological activity and safety profile of the active substances and for product registrations. Responsible for overseeing junior scientists. Manages laboratory activities.

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, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

Duties & Responsibilities

• Develop, validate and utilize methods for the determination of drug residues in biological or environmental matrices in compliance with established global regulatory requirements. Troubleshoots problems with bioanalytical methods.
• Serve as Study Director or Principal Investigator for bioanalytical validation, pharmacokinetic, efficacy, safety and drug metabolism studies in accordance with GLPs. Authors bioanalytical protocols and reports.
• Operates and maintains, as well as directing others in the operation and maintenance, of MS instrumentation and HPLC equipment in a validated state. Provide technical expertise to recommend approaches and equipment to develop and maintain a state of the art laboratory. Works with outside vendors to assure maintenance of laboratory equipment and operations.
• Ensures routine instrument backups, virus checks and performance maintenance for assigned systems.
• Troubleshoots problems with MS and HPLC systems.
• Interact with regulatory agencies in discussing the enforcement method, performing method demo and organize and participate in method trials.
• Demonstrates 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. Keeps abreast of relevant literature.
• Develops visibility outside of functional area and effectively interacts scientifically with in relevant fields of research. Publishes research in peer reviewed journals and presents data at national/international meetings as requested.
• Go-to expert in the bioanalytical area.
• Skillfully collaborates and cooperates within the global bioanalytical team (GBA) and across functions (internal and external stakeholders) to assurebioanalytical activities for project teams are delivered efficiently, while achieving continuous improvement in quality including, speed and value of processes supporting studies. Develops and leverages Contract Research Organizations as necessary.
• Collaborates with AH Global Bioanalytical Team.
• Support, encourage, manage, coach and train colleagues, on best practices for study execution with flawless speed and compliance. Acts as a professional & collaborative team member demonstrating accountability, and alignment within the global bioanalytical team and with all stakeholders. Cooperates with site personnel, study directors and core team members. Assumes responsibility for direct reports including recruiting, managing, mentoring and developing scientific staff.
• Ensures compliance in the area of GLPs with VICH, OECD, and EPA guidelines, animal welfare and local regulatory requirements. Authors and maintains relevant SOPs to ensure GLP compliance of equipment is met. Knowledge of GLPs and guidelines.
• Expert on GLPs and guidelines.
• Complies with all applicable regulations governing the Animal Health Industry (GLP, Animal Welfare, Regulatory requirements, etc.). 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.

Requirements

• PhD (or equivalent) in biochemistry/biology or a related field from an accredited institution or MS from an accredited institution with significant experience.
• Considerable experience (greater than five (>5) years) in veterinary research & development.
• A minimum of five (5) years of broad experience in a related field with a proven track record of successfully implementing or investigating technologies and adding value to the organization or equivalent combination of education and experience.
• Hands-on experience with PK and Human Food Safety studies, estimation of exposures and drug concentrations, validation, method development and sample analysis.
• Knowledge of basic principles of PK and metabolism, as well as the relevance in the veterinary drug development.
• Solid understanding of chemistry and related fields contributing to an understanding of the basic principles of chromatography, mass spectroscopy and sample extraction methods.
• Able to effectively work in an international and cross-functional matrix environment
• Knowledge of global regulatory requirements (e.g. FDA, EMA) and compliance.
• Experience in analyzing literature and technology trends in bioanalytical chemistry.
• Experience with planning, conducting, reporting, analyzing and interpreting bioanalytical studies.
• Experienced in project/program management.
• Research methodology experience.
• An analytical thinker.
• Excellent skills in understanding data and scientific decision processes, and in interpreting and reporting these data in well supported conclusions targeted at achieving project objectives.
• Strong leadership skills.
• Able to mentor others with the global bioanalytical team without formal authority.
• Fosters innovation.
• A problem solver.
• Good communication and interpersonal skills.
• A collaborative team player.
• Values diversity and inclusion.
• Possesses a customer service orientation, delivering results and executing in a fast and focused manner.
• Exceptional planning and organizational skills with a quality orientation.
• Strives for business process excellence.
• Accepts accountability and ownership.
• Exhibits integrity and trust.
• English: Fluent (read, write and speak)
• Demonstrates industry-leading knowledge of field.
• Ability to communicate effectively both orally and in writing in an interdisciplinary and international environment.
• Knowledge of the Pharmaceutical life cycle process.
• Exhibits business and technical knowledge.
• Independently develop method and performing sample analysis without supervision, act as study director, report writing and participate in method demo and method trial.
• Responsible for direct reports including recruiting, managing, mentoring and developing scientific staff.
• Go-to expert in the bioanalytical or metabolism area.
• Work on the subteam.