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 Formulation Scientist is to perform 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
- Develop stable product formulations that meet or exceed requirements within specified timelines.
- Conduct process optimization studies to develop robust manufacturing process.
- Work with analytical team to design methods.
- Conduct formulation studies according to Quality by Design.
- Collect all data generated during formulation and analytical development and prepare Product Development Reports.
- Respond to deficiencies from the regulatory agencies with further data or clarifications to obtain approvals in shortest possible time.
- Communicate with CMOs during technology transfer activities. Travel may be needed during scale up/pilot batches.
- Collaborate with Regulatory Affairs teams during preparation of submissions to FDA.
- Scientist with at least Bachelor’s degree or comparable degree in pharmaceutical sciences and minimum of 5 years of employment within pharmaceutical industry. Higher degrees are preferred.
- Experience developing liquid formulations (injectables, ophthalmics, oral solutions/suspensions).
- Knowledge of pre-formulation, manufacturing technology and scale-up as well as FDA & DEA regulations.
- 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