Senior Scientist, Clinical Analytical

The basic purpose of this position is to design and execute independent research that supports R&D projects. The Senior Scientist is primarily responsible for performing and managing scientific and technical activities, which may also include management of scientific staff. The position will be part of a research team which develops and validates assays used in clinical trials to evaluate the efficacy and safety of vaccine/biological test articles. This position will be a technical leader that fulfills the role of subject matter expert within Clinical Analytical and as needed within multidisciplinary project teams.

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.

• Independently performs 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 design and results of technicians and junior level scientists.
• Develops 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 a Clinical Analytical representative on multiple project teams and contributes to defining expertise-related aspects of overall program goals.
• Prepares clear technical reports, publications and oral presentations. Independently communicate 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 goals.
• Develops Clinical Analytical 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. Interacts routinely and effectively with other functions, e.g. Regulatory, Quality Assurance (QA), Developmental Projects, Clinical, Data Management, and Research.
• Keeps abreast of relevant literature. Develops visibility outside of functional area. Actively develops and manages relationships with CROs as needed to maintain Clinical Analytical testing for development projects when internal resources are limited.
• Assumes responsibility for direct reports as needed including recruiting, managing, mentoring and developing scientific staff.
• Complies 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 policies.
• Contributes to departmental administration; Demonstrates fiscal responsibility with respect to cost of experiments, technology, external collaborations, and travel.

• PhD degree from an accredited institution in a Biological Science with at least five (5) years of relevant experience in biological product development; Or
• Masters degree from an accredited institution with at least ten (10) years of relevant experience in biological product development.
• Greater than eight (> 8) years of experience and expertise in biological assay development utilizing multiple assay formats- cellular, molecular, and immunological.
• One to three (1-3) years of leadership experience (e.g. functional lead or project leader). Knowledge of USDA and VICH regulatory guidelines for assay validation.
• Experience in supervising 2-3 direct reports; Leadership of multi-disciplinary teams and direct reports.
• Knowledge and experience in validation of biological assays.
• 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.
• Experienced in project/program management.
• Should have training on EU, USDA, and VICH guidelines.
• Excellent knowledge of biological product development.
• Should have basic working understanding of the following assay technologies:
  • ELISAs and chemiluminescent or fluorescent binding assays
  • SDS-PAGE and protein blotting
  • HPLC
  • Virus titration or plaque assays
  • Expression assays for GMOs
  • Bacterial enumeration assays such as CFU
  • Focus forming assay
  • Fluorescent cytometry
  • PCR and qPCR
  • Protein purification
  • Monoclonal antibody technology
  • Tissue culture methods
  • Culture of viruses
  • Culture of bacteria
• Willingness to take risks and incorporate latest assay technologies in Clinical Analytical (e.g., Robotics, Immuno-fingerprinting).
• Strong interpersonal skills and communication skills.
• Good oral and writing skills; Ability to communicate effectively both orally and in writing in an inter-disciplinary environment.
• Operational and strategic thinking.
• Skilled in conflict resolution and negotiation.
• Achievement focused with appropriate alignment for regulatory and quality requirements.
• Decision making skills critical with ability to solve problems with speed to change.
• Ability to act as or to support team heads and team members to become internal key-opinion leader.
• Capability to deal with variety of challenging matters including set-backs and failures.
• Transparent communication, especially of risks, failures and learnings.
• Positive attitude and willingness to teach others Research methodology experience.
• Demonstrates industry-leading knowledge of field.
• Demonstrated knowledge of the Biologicals life cycle process.
• An analytical thinker.
• A problem solver, fosters innovation.
• Exhibits business and technical knowledge.
• 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.
• Ability to challenge teams and team heads and able to recommend innovative alternatives.
• A collaborative team player.
• Values diversity and inclusion.
• Accepts accountability and ownership.
• Exhibits integrity and trust.
• Willingness to travel internationally.

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.