Scientist II, Clinical Analytical

Description

Participates and assists in the design and execution of clinical testing methods to support biological development (vaccines, therapeutics, etc.) in different animal species. Evaluates samples coming from clinical studies with the appropriate methods. Performs customary scientific/lab duties with minimal supervision. Performs all work in conformance with applicable regulations and in a safe manner.

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

• To assure Clinical Analytical missions:
  • To set up, execute studies and support development of robust and reliable methods for clinical testing.
  • To assist in the transfer of methods to QC or other analytical lab as needed.
  • To carry out and assure the evaluation of samples coming from clinical studies with the appropriate methods.
  • To troubleshoot technical issues and provide recommendations to increase efficiency.
  • To ensure the compliance with GLP or other requirements; making sure that all the data are recorded and the documents and files checked, secured and approved.
  • To maintain the Clinical Analytical lab.
  • To apply basic scientific principles with minimal guidance. Assist in the design and execution of non-routine experiments with supervision.
• To contribute to the technical and scientific innovation:
  • To propose and implement new methods and/or technologies to support R'D projects.
  • To performs literature searches and extracts relevant information from published protocols.
• To contribute to the project advancement:
  • To follow protocols, complete results, and provide data compilation for reports.
  • To correctly analyze data/results and interpret outcome of experiments and to propose appropriate follow-up.
  • To present clinical testing results in department meetings.
  • To develop and maintain interfaces with Analytical team members, internal partners, and customers (clinical R'D, Project Leaders, R'D teams).
  • To ensure that all the information and documentation necessary for Analytical leadership, R'D Leaders, clinicians and registration is available in the agreed upon time.
• Complies with applicable regulations, performing all work in a safe manner; maintains proper records in accordance with Standard Operating Procedures (SOPs) and policies.

Requirements

• Bachelor's Degree from an accredited institution with minimum of two (2) years of experience in related scientific discipline; or Master's Degree from an accredited institution in related scientific discipline with no experience.
• Background in immunology, cell and molecular biology, vaccinology
• Knowledge of analytical development and validation
• Prior experience with biological assay development is preferred
• Basic level of understanding of USDA and EMEA requirements
• Must be able to work cross-functionally
• Demonstrate knowledge of field
• Apply knowledge of basic theory and scientific principles
• Able to draft portions of technical reports
• Ability to learn new technology and concepts and apply appropriately with minimal supervision
• Concise and accurate reporting of technical data and information
• Ability to troubleshoot
• Written and verbal communication skills
• Appropriate level of understanding of applicable regulations

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.

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