Join Our Team

Eton Pharmaceuticals is always interested in hiring employees that are experienced, highly motivated, and passionate about innovative drug development. Eton offers an excellent salary and benefits package including medical, dental and vision coverage, as well and 401K with company match.

We are currently have openings for the following positions:

REGULATORY AFFAIRS SPECIALIST
Location: Deer Park, IL US
Job Category: Regulatory Affairs

Description

Summary

The core job responsibility of the Regulatory Affairs Specialist is to support all activities related to FDA submissions. 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

  • Prepare Regulatory submissions including New Drug Application (NDA), and INDs in accordance with the current FDA requirements.
  • Prepares Amendments, Supplements, and DMF’s in line with regulatory requirements and GMP compliance.
  • Write responses to regulatory authority deficiency questions.
  • Ensure timely and accurate submissions per business objectives and determine deliverables that are aligned with regulatory strategy.
  • Coordinate preparation of meeting packages and materials for FDA meetings and interactions.
  • Prepare standard operating procedures or working practices ensuring regulatory compliance.
  • Monitor applicable regulatory requirements and assure compliance with corporate standards and guidance documents.
  • Provide support to Quality Assurance during internal audits.
  • Provides regulatory guidance to other departments.

Qualifications:

  • Candidate with at least Bachelor’s degree in chemistry, biology, microbiology or pharmacy and minimum of 5 years of regulatory affairs experience. Advanced degree preferred.
  • Experience with preparing submissions in eCTD software is required.
  • 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.

Additional Information

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 careers@etonpharma.com

ANALYTICAL SCIENTIST
Location: Lake Zurich, IL US
Job Category: Analytical Development

 

Description

About Eton

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.

Summary

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.

Qualifications:

  • 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.

Additional Information

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 careers@etonpharma.com

FORMULATION SCIENTIST
Location: Lake Zurich, IL US
Job Category: Product Development

Description

About Eton

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.

Summary

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.

Qualifications:

  • 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.

Additional Information

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 careers@etonpharma.com

To apply, please email a cover letter and resume to careers@etonpharma.com