(Archived) SR Scientist, Bioanalysis

Description: Independently planning strategies for studies to reach goals and milestones. Designs and executes experiments or studies that follow templates, or creates improved and novel study designs that lead to new approaches for supplying product attributes or product goals. Fulfills a role as a subject matter expert in representing his/her function and providing communication on project core teams. Contributes technical approaches and scientific support to regulatory affairs in meeting regulatory requirements. The primary scope of responsibility is as a technical leader within their immediate function and secondarily within a multidisciplinary project team. Responsible for providing expertise in the areas of Mass Spectrometry, Ultra High Performance Liquid Chromatography, plasma and tissue sample preparation, bioanalytical method development and validation. Conducts residue analysis for pharmacokinetic, metabolism, 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: Independently initiates, designs, interprets and coordinates strategic 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. May direct and oversee experimental study design and data analysis/results of junior-level scientists. Develop, validate, troubleshoots, modify and utilize methods in compliance with global regulatory requirements. Independently operates, troubleshoots and maintains, as well as directing others in the operation and maintenance, of MS/HPLC instrumentation 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 are performed by team. Interacts with cross-functional Global Innovation Research and Development Project Leaders and Teams to: Develop an understanding of team goals and leads self and junior scientists toward effectively achieving them. Assumes departmental responsibility for projects in reporting of project progress, timelines and budgets to steering committees. Contributes to departmental administration; demonstrates fiscal responsibility with respect to cost of experiments/studies, technology, external collaborations and travel. Manages study budgets and follows internal processes to execute financial responsibility. Provide guidance and expertise to evaluate the need for new technologies and concepts in support of multiple projects. Proposes, evaluates and implements new technologies. Demonstrates a solid level of technical proficiency in field; trains junior level scientists in this field. Go-to expert in the bioanalytical area for Global Innovation. Reports and treats data with a high level of integrity and ethics. Independently produce well written, accurate, protocols, procedures, technical summaries and scientific reports. Effectively communicates and defends own work, orally and in writing, in the context of the team goals at meetings. Presents responsibly and defends own work and work of others at meetings. May deliver updates to senior-level management in context of overall project goals. Contributes and presents project related topics within Regulatory forums (FDA). Develops visibility outside of functional area and effectively interacts scientifically in relevant fields. Effectively liaises internally with cross-functional stakeholders (Sales & Marketing, Legal, Finance, Operations), to communicate and align expectations. Independently applies basic scientific principles, performs literature searches, attends scientific meetings, and keeps abreast of literature in own field. Enhance individual and corporate recognition through presentations and publications to internal and external audiences and participate in professional and technical associations. Publishes research in peer reviewed journals and presents data at national/international meetings. Recruit, support, encourage, manage, develop, coach and train colleagues, on best practices for study execution with speed and compliance. Assumes responsibility for direct reports. Skillfully collaborates and cooperates within the AH Global Bioanalytical Team and across functions (internal and external stakeholders). Assures that team collaborates and helps with distribution of work to avoid project delays. Develops and leverages Contract Research Organizations. •Ensures compliance of self and others with VICH, OECD, and EPA guidelines, animal welfare, local regulatory requirements, GLPs, safety policies, SOPs and company policies. Ensures that work performed by self and direct reports is conducted in a safe and compliant manner. Authors and maintains relevant SOPs to ensure GLP compliance of equipment, processes and work packages is met for self and team/department. Expert on GLPs and guidelines. Serve as Study Director or Principal Investigator leading junior scientists in completing work. Interact with regulatory agencies in discussing the enforcement method, performing method demo and organize and participate in method trials. Assist in expert statements and answering questions for regulatory purposes for area of expertise. Requirements: PhD from an accredited institution in chemistry or related field with greater than five (>5) years of industry experience; or MS from an accredited institution in chemistry or related field with greater than ten (>10) years of AH industry experience. Considerable experience (greater than five (> 5) years) in veterinary research & development Research methodology experience. 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. Demonstrates a broad knowledge of field 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 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. Independently develop method and performing sample analysis without supervision, act as study director, report writing and participate in method demo and method trial. Influencing departmental direction with knowledge of technology trends Demonstrates Industry-leading knowledge of field. Demonstrates knowledge of the pharmaceutical life cycle process. Go-to expert in the bioanalytical or metabolism area. Work on the project subteams. 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. Exhibits business and technical knowledge. Outstanding communication skills for effective oral and written communication in an inter-disciplinary and international environment. Outstanding interpersonal skills. A collaborative team player. 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. Strong leadership skills. Able to mentor others within the global bioanalytical team without formal authority. A problem solver. Fosters innovation and drives change Values diversity and inclusion. Responsible for direct reports including recruiting, managing, mentoring and developing scientific staff. English: Fluent (read, write and speak). 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. Who We Are: At Boehringer Ingelheim we create value through innovation with one clear goal: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company we focus on long term performance. We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture. Learning and development for all employees is key because your growth is our growth. Want to learn more? Visit boehringer-ingelheim.com and join us in our effort to make more health. Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities. All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law. #LI-JB1