Immunogenicity /Bioanalysis Scientist III- IV (ADA)
Description:Description\: The Biotherapeutic Bioanalysis group conducts immunogenicity/anti-drug antibody (ADA) and drug concentration (PK) bioanalyses of protein-based drugs internally, and manages nonclinical and clinical ADA and PK bioanalytical work at CROs. The Biotherapeutic Bioanalysis Group also generates and characterizes critical reagents used in the PK and ADA bioanalyses, and conducts mechanistic studies to understand non-routine PK and immunogenicity issues. As a Scientist III or Scientist IV, your main responsibility will include based on the level\: independently develop and validate ADA immunoassays, and serve as a scientific monitor for outsourced ADA bioanalytical work at CROs for nonclinical and clinical development. With minimal supervision, you will oversee ADA assay transfer, development, troubleshooting, validation and sample analysis at CROs. You will also review scientific data and reports to ensure data accuracy and integrity. You will serve as a mentor for junior laboratory scientists. 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 implement ADA immunoassays. Mentor junior level scientists in ADA testing. Propose novel strategies and technologies for implementation; independently apply basic scientific principles, perform literature searches, attend scientific meetings, and keep abreast of literature in the biotherapeutic bioanalysis field. Demonstrate strong technical proficiency in large molecules immunoassays. Oversee ADA method development, validation, and sample analysis at CROs to ensure regulatory requirements (GLP/GCP) and industry practices are followed. Review method development data, validation reports, and bioanalytical reports. Manage CRO study timelines, track study progress; provide necessary reagents, and help with troubleshooting of transferred methods in a timely manner. Ensure smooth transfer of nonclinical and clinical data in agreed-upon file formats from CROs. Provide update of project status at periodic project review meetings. Report and treat data witha high level of integrity and ethics. Comply with applicable regulations (GLP and GCP); maintain proper records in accordance with SOPs and policies. Participate in cross departmental project teams when assigned. Requirements Sci IV\: Must be legally authorized to work in the United States Must be willing to submit to a background investigation, including verification of your past employment, criminal history, and educational background Must be 18 years of age or olderOur Culture\:Boehringer Ingelheim is a different kind of pharmaceutical company, a privately held company with the ability to have an innovative and long term view. Our focus is on scientific discoveries that improve patients' lives and we equate success as a pharmaceutical company with the steady introduction of truly innovative medicines. Boehringer Ingelheim is the largest privately held pharmaceutical corporation in the world and ranks among the world's 20 leading pharmaceutical corporations. At Boehringer Ingelheim, we are committed to delivering value through innovation. Employees are challenged to take initiative and achieve outstanding results. Ultimately, our culture and drive allows us to maintain one of the highest levels of excellence in our industry. Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Roxane Inc., Roxane Laboratories Inc., Boehringer Ingelheim Chemicals, Boehringer Ingelheim Vetmedica Inc. and Ben Venue Laboratories Inc., is an equal opportunity employer. M/F/D/V Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, partners and customers.
- Master's Degree with 6+ years experience in a related scientific discipline; or Bachelor's Degree with 10+ years experience in a related field; or equivalent experience in a related field
- Advanced training in the area of technical expertise
- Demonstrate knowledge of field
- Propose new experimental designs and conduct probing experiments
- Plan and conduct laboratory experiments and evaluate and interpret data
- Provide training and guidance to laboratory personnel
- Prepare technical reports, publications and oral presentations
- Act as a leader in absence of supervisor
- Appropriate level of understanding of applicable regulation
- Knowledge and hands-on experience developing immunogenicity assays, utilizing ELISA- and/or MSD-based platforms; demonstrated immunoassays trouble shooting skills.
- Experience working in a GLP/GCP environment is a plus.
- Experience as a scientific monitor of biotherapeutic bioanalysis at CROs is desirable.
- Good organizational and time management skills in order to handle multiple projects in parallel.
- Effective oral and written communication skills.
- Ability to critically evaluate and interpret data.
- Experience mentoring and providing guidance to junior scientists is desired.
- Experience developing Cell based assays for large molecules is a plus.
- Experience in mechanistic studies to understand non-routine immunogenicity issues is a plus.
- Master's Degree with 3+ years experience in related scientific discipline; or Bachelor's Degree with 7+ years experience in related scientific discipline; or equivalent experience in related field
- Supplemental technical courses in area of expertise
- Ability to operate laboratory equipment with independence
- Ability to draft technical reports
- Demonstrate written and verbal communication skills
- Concise and accurate reporting of technical data and interpretation thereof
- Proven problem solving ability
- Able to act for supervisor in his/her absence
- Appropriate level of understanding of applicable regulations