The Environmental Fate and Exposure Scientist provides scientific expertise to address global environmental regulatory requirements to achieve and maintain product registrations, as well as sustainability initiatives. The person in this role is responsible for independently designing and reporting environmental fate and exposure programs and integrating these data into environmental assessments. The Environmental Fate and Exposure Scientist will support Global Innovation teams, as well as in-line products.
The Environmental Fate and Exposure Scientist will represent Drug Safety and DMPK in collaborative efforts within Boehringer Ingelheim Animal Health (BIAH) and with outside organizations, Regulatory Authorities, and international subject matter experts.
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 several 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:
- Determines environmental risk assessment strategy.
- Functions as in-house consultant and technical expert in areas of expertise; assesses and communicates environmental risk.
- Keeps current with worldwide regulations for assessing environmental impact of veterinary compounds.
- Participates in presentations to regulatory agencies, when needed.
- Actively participates in professional/technical associations.
- Functions as a Sponsor Representative on environmental fate, exposure, physical chemical, and environmental studies.
- Develops protocols in collaboration with CROs.
- Designs environmental fate and exposure studies.
- Conducts or directs all activities in compliance with established regulatory requirements.
- Evaluates, interprets, reviews, and summarizes technical data.
- Prepares and reviews reports, memos, SOPs, and regulatory documents with minimal oversight.
- Responsible for preparation of environmental assessments.
- Conducts environmental exposure modeling and interprets data to support environmental risk assessments.
- Defines environmental testing program requirements and implementing environmental testing programs.
- Ensures compliance with relevant regulatory and GXP as well as BIAH Policies, Procedures and Guidelines.
- Responsible for designing and implementing environmental fate and exposure programs.
- Responsible for synthesizing information from scientific and regulatory literature, and across multiple projects, identifying and addressing data gaps and developing weight of evidence arguments based on solid scientific principles.
- Communicates with project team members and stakeholders in a matrix organization.
- Balances competing projects of varying complexity and prioritizes work according to business objectives.
- Anticipates future regulatory positions and developments to define and execute environmental testing programs.
- Assures appropriate reporting of environmental and/or other safety data to support complex regulatory submissions.
- As necessary, provides support for presentation and discussion of safety positions to regulators.
- Cooperates and communicates with internal and external stakeholders in other Clinical R&D functions, pharma R&D, Regulatory, Project Leaders and Project Teams, as well as other BI functions such as Finance, Legal, and Human Pharma.
- Interfaces with consulting technical experts (KOLs), Contract Research Organizations, academia, industry groups and regulators, and consortia (e.g., AHI and IFAH).
- Accountable for the successful generation and delivery of pivotal data to complete the environmental technical section of pharmaceutical product dossiers and to support claim extensions, and to allow decision making regarding labeling to mitigate risk.
- Ensures the continued success of the BIAH pipeline and ensures a critical mass to address due diligence required for ongoing, newly implemented, and future environmental legislation associated with animal health products.
- Defines environmental safety of AH Pharma products globally, impacting the BIAH portfolio globally.
- Accountable for the technical development of the environmental section of regulatory submissions.
- PhD in Environmental Chemistry or a related field.
- Greater than three years of experience assessing the environmental fate and exposure of chemicals, including authoring environmental risk/impact assessments.
- Experience in the development and registration of pharmaceutical, chemical or crop science products.
- Knowledge of worldwide technical guidance's and exposure models for environmental fate and exposure assessments.
- Experience in protocol development and study design, data management and processing, analysis, and collation to generate environmental risk/impact assessments.
- Excellent English verbal, written and presentation skills.
- Advanced skills in Excel, Word, PowerPoint.
- Familiarity with utilizing environmental modeling software.
- Experience with environmental exposure modeling, including model development and interpretation, in terrestrial and aquatic ecosystems.
- Working knowledge of international regulatory guidelines applicable to environmental safety and exposure studies, environmental impact assessments and data interpretation by regulatory bodies.
- Act always according to industry and Company standards and ethics.
- Must have advanced knowledge and extensive practical industrial experience in relevant R&D field, preferable in animal health.
- Provide applied, mechanistic, and regulatory expertise for assessment of environmental fate and exposure of chemical and/or pharmaceutical products.
- Have a proven track record of generating and defending environmental risk assessments.
- Possesses the skills to successfully negotiate regulatory outcomes employing novel technical arguments, across classes of compounds for product defense/registration and environmental risk assessment purposes.
Who We Are:
- 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.
- This position will require individuals to be fully vaccinated against COVID-19 or have an approved medical or religious accommodation. Click here for more information on the vaccine mandate and COVID-19.
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.