Scientific Affairs Director, Toxicology

The Opportunity

The position of Scientific Affairs Director is within our Toxicology business unit. The person can work onsite in either our Lake Forest, IL or Pomona, CA locations.

This role will provide Toxicology Business Unit Strategic direction through leading interactions with Toxicology Key Opinion Leaders, Government agencies, Professional Societies and potential strategic partnership that will advance Business Unit strategic Plan.

This role is to provide Scientific insight throughout Abbott Toxicology, engaging with internal and external entities, collating, and summarizing data, presenting at professional conferences and assuring with technical projects.

This role will also be responsible for overseeing the development and implementation of an analytical procedures; presenting data at professional conferences;

publishing new method and assay data; assisting with technical marketing projects; collation of data from external research projects.

This is not available for hybrid or remote work.

What You’ll Work On

Ensure that new products meet the needs of a rapidly changing drug testing field.

Work closely with the biologics group for appropriate selection of antibodies.

Provide scientific rationale for cut-offs and cross-reactants as necessary.

Ensure research group maintains leadership in the field of analytical technologies related to immunoassays.

Work with Regulatory Assurance group and other departments to assist in development, documentation and registrations (e.

g. IVDR and FGDA 510K) for novel technologies and products.

Participate in Design Review and other meetings as required for new product development and launch.

Assist in product marketing by providing technical information, presentations, and review.

Assist in resolving customer complaints if necessary.

Work across the business units to provide technical leadership in product development.

Represent the company in a professional capacity including, but not limited to, at scientific conferences, on advisory boards, in relevant working groups and during government communications.

Oversee development and implementation of analytical procedures which support company products.

Collaborate with external researchers on grant submissions.

Organize or assist in promoting relevant workshops, webinars, and presentations.

Develop projects with law enforcement to address issues surrounding DUID and traffic safety.

Remain active in relevant professional societies.

Provide technical expertise to legislators and the public regarding new matrix analysis for drug testing in drivers.

Understands and is aware of the quality consequences which may occur from the improper performance of their specific job;

has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.

Exhibit professional behavior with both internal / external business associates that reflects positively on the company and is consistent with the company’s policies and practices;

build productive internal / external working relationships.

Performs duties in compliance with established business policies.

Other duties as assigned, according to the changing needs of the business.

Required Qualifications

PhD in field of analytical chemistry, forensic toxicology, Clinical Chemistry, Clinical Toxicology, or Immunochemistry.

Board certification in clinical chemistry or related subject.

Travel required 25-30%

Minimum of 10-12 years laboratory experience

Working knowledge of immunoassay and mass spectrometry

Excellent writing and communication skills for preparation of publications, reports, and presentations

History of diverse, published, peer-reviewed scientific papers.

Effective organizational capabilities

Strong people skills and ability to work as a team player.

Knowledge of computers and software programs including Word, Excel, Power Point, and document management programs

Ability to work in highly matrixed, cross functional organization.

Preferred Qualifications

Analysis of biological specimens for drugs in a high throughput laboratory environment

Data review for immunoassay screening and mass spectrometry results

Experience leading and supervising scientific staff

FDA device interaction experience

Tox lab and / or production service lab management experience