Lake Zurich, IL US
Eton Pharmaceuticals, Inc. is a Deer Park, Illinois-based biopharmaceutical company focused on developing and commercializing innovative products utilizing the U.S. Food and Drug Administration’s 505(b)(2) regulatory pathway. Our mission is to advance healthcare through the introduction of innovative medicines that are affordable and available to all patients.
The core job responsibility of the Analytical Scientist is to perform analytical development, validation and testing supporting drug product development. The level of position will be determined based on applicant’s qualifications. This position reports to Sr. Vice President of Regulatory Affairs and Product Development.
Key Duties and Responsibilities
- Perform method development, optimization and validation of analytical procedures for active pharmaceutical ingredients and finished products.
- Provide any additional analytical support within Drug Product Development for assigned project.
- Plan and perform method transfer activities and represent analytical development with tech transfer teams.
- Perform analytical tests using established methods including release testing of clinical supplies and stability testing.
- Evaluate complex analytical data, prepare and update documentation (methods, reports and plans) related to analytical development.
- Communicates with CMOs and CROs with respect to analytical aspects of the projects.
- Prepare documentation in support for regulatory submissions to FDA.
- Provide support for testing and preparation of deficiency responses.
- Perform all tasks under GLP/GMP conditions.
- Support introduction or update of new analytical technologies.
- Scientist with at least Bachelor’s degree or comparable degree in chemistry and minimum of 5 years of employment within pharmaceutical industry.
- Advanced analytical knowledge and experience.
- Theoretical and practical knowledge and experience in the fields of chromatography, spectroscopy, dissolution and wet chemistry.
- Theoretical and practical knowledge and experience using HPLC, GC, ICP, IC and preferably LC/MS.
- Technical system skills (e.g. word processing, spreadsheets, databases, online research).
- Manage multiple projects and deadlines.
- Good communication and written skills.
- Ability to identify compliance risks and escalate when necessary.
Equal Employment Opportunity
Eton is equal opportunity employer. Eton evaluates qualified applicants without regard to color, religion, race, age, gender, sexual orientation, nationality, veteran status or any other legally protected characteristic.
Eton offers an excellent salary and benefits package including medical, dental and vision coverage, as well and 401K with company match.
To apply, please email a cover letter and resume to firstname.lastname@example.org