Scientist IV, Bioanalysis
Boehringer Ingelheim
**Description**
This position is onsite in Fulton, MO, near the Columbia, MO area
The Scientist IV is responsible for designing and executing routine and non-routine experiments or trials that follow templates established by earlier studies or that use new designs, without supervision and following a strategy confirmed with his/her manger. Interprets results and writes protocols or reports with review by his/her manager. Responsible for both technical and communication roles for his/her function to project core teams. Perform all work in a safe manner. The primary scope of responsibility is within the immediate function and secondarily within a multi-disciplinary project team. Participate in the execution of a global development strategy for new pharmaceutical products (early research through regulatory submission). Independently operates, troubleshoots and maintains MS/HPLC instrumentation in a validated state.
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**
+ Initiates, designs, interprets accurately, troubleshoots and completes routine procedures independently and efficiently;
+ Initiates, designs, interprets accurately, troubleshoots and completes difficult and non-routine procedures independently and efficiently generally without supervision;
+ Develop, validate, troubleshoots, modify and utilize methods in compliance with global regulatory requirements.
+ Independently operates, troubleshoots and maintains 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 for assigned systems.
+ Acts as a collaborative team member demonstrating accountability, and alignment within the Global Bioanalytical Team and with all stakeholders. Cooperates with site personnel, study directors and project team members.
+ Proposes, gains support for and implements ideas from individual’s knowledge of science and technology and understanding of drug exploratory, research and development process.
+ May participate in project teams as subject matter expert or subteam member representing Bioanalytical/Metabolism team.
+ Proposes, evaluates and implements new technologies;
+ Demonstrates a solid level of technical proficiency and expertise in field; trains junior scientists when needed.
+ Function as a consultant in areas of expertise within the department.
+ Reports and treats data with a high level of integrity and ethics;
+ Develop technical knowledge by utilizing available personnel, information and training resources.
+ Independently produce well written, accurate, protocols, procedures, technical summaries and scientific reports complying with scientific, business and regulatory need .
+ Effectively communicates and defends own work, orally and in writing, in the context of the company and team goals at meetings.
+ Develops visibility outside of functional area and effectively interacts scientifically in relevant fields.
+ 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 to internal audiences and participate in professional and technical associations.
+ Participation in cross department project teams as needed.
+ Skillfully collaborates and cooperates within the global bioanalytical team and across functions (internal and external stakeholders).
+ Assure bioanalytical activities for project teams are delivered efficiently, while achieving continuous improvement in quality, speed and value.
+ Leverages Contract Research Organizations.
+ Complies with VICH, OECD, and EPA guidelines, animal welfare, local regulatory requirements, GLPs, safety policies, SOPs and company policies.
+ Ensures that work performed 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.
+ Knowledge of GLPs and guidelines.
**Requirements**
+ PhD from an accredited institution in chemistry or related field; or
+ MS from an accredited institution with greater than six (>6) years of relevant experience.
+ Advanced training in the area of technical expertise.
+ Experience with clinical and nonclinical studies and/or scientific research.
+ Demonstrate knowledge of field, technology trends, and analytical thinking.
+ Knowledge of 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.
+ Developing knowledge of Life Cycle Process.
+ Demonstrated project/program management skills.
+ Propose new experimental designs, Conduct probing experiments.
+ Plan and conduct scientific/laboratory experiments and evaluate and interpret data.
+ Provide training and guidance to laboratory personnel.
+ Prepare technical reports and oral presentations.
+ Act as a leader in absence of supervisor.
+ Working knowledge of study design and analysis of results.
+ Strong team work and collaboration skills.
+ Excellent communication, time management and organizational skills.
+ Excellent written and spoken English, additional language skills e.g. German an advantage.
Preferred Experience:
+ Demonstrated expertise in LC-MS/MS and HPLC-based method development, validation, and troubleshooting
+ Proficiency in immunoassay techniques such as ELISA, MSD-ECL, Gyrolab, and Flow Cytometry is desirable
+ Experience with Ligand Binding Assays and hybrid LBA–LC-MS/MS workflows for PK and ADA analysis is a plus
+ Familiarity with Watson LIMS, Sciex Analyst/OS, Electronic Lab Notebooks (ELN), and other relevant bioanalytical data systems is beneficial
**GI_US925**
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.
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