Drug Product Formulation Specialist

Job Title: Drug Product Formulation Specialist - 2 Openings

100% Remote

Experience required:

• MS or higher with at least 10 years' experience
• prior experience performing review for NDA module submissions
• prior experience with lyophilized viral formulation
• Drug Product experience/focus
• Familiarity with regulatory requirements for drug product formulation

Job Description: We are seeking experienced Drug Product Formulation Specialists to support our team in conducting secondary reviews of source documents and NDA Module submissions. This role requires expertise in lyophilized vial formulation and experience with sterile products.

Key Responsibilities:

• Conduct secondary review of source documents and NDA Module submissions related to drug product formulation.
• Provide expertise and guidance on lyophilized vial formation processes.
• Ensure compliance with regulatory standards and internal quality requirements.
• Collaborate with cross-functional teams to resolve formulation-related issues.

Key Requirements:

• MS with at least 10 years’ experience in a relevant setting.
• In-depth knowledge and proven experience in lyophilized vial formulation.
• Background in sterile product development and manufacturing.
• Familiarity with regulatory requirements for drug product formulation.
• Ability to critically analyze and review technical documents.
• Strong communication skills to effectively collaborate with internal and external stakeholders.

Additional Details:

• Contract Type: Part-time, 20 hours per week.
• Duration: July 15th to October 30th (with possibility of extension).

Desired Qualifications:

• Prior experience in performing secondary review for NDA Module submissions.
• Proactive attitude towards problem-solving and process improvement.

This role offers an exciting opportunity to contribute to critical drug product development activities, ensuring high standards of quality and regulatory compliance. If you have the necessary expertise and are ready to make an impact, we encourage you to apply promptly.

Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.

If you would like to complete our voluntary self-identification form, please click here or copy and paste the following link into an open window in your browser: https://jobs.beaconhillstaffing.com/eeoc/

Completion of this form is voluntary and will not affect your opportunity for employment, or the terms or conditions of your employment. This form will be used for reporting purposes only and will be kept separate from all other records.

Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.

If you would like to complete our voluntary self-identification form, please click here or copy and paste the following link into an open window in your browser: https://jobs.beaconhillstaffing.com/eeoc/

Completion of this form is voluntary and will not affect your opportunity for employment, or the terms or conditions of your employment. This form will be used for reporting purposes only and will be kept separate from all other records."