Scientist, Formulation Development

Integrated Resources Inc.; East Windsor Township (NJ); On-site; USD 85,000 - 115,000; Full time

Job summary

A leading company is seeking a Formulation Development and Process Development Scientist with at least 3 years of experience in the generic drug industry. The ideal candidate will have a Master’s or PhD in Pharmaceutics, knowledge of the ANDA filing process, and a thorough understanding of pharmacokinetics. This role involves developing drug dosage forms and ensuring compliance with regulations. Excellent communication and teamwork skills are essential.

Qualifications

• 3+ years of experience in the generic drug industry with ANDA filing experience.
• Experience with DEA controlled drug substances preferred.
• Ability to work in a team with excellent communication skills.

Responsibilities

• Develop and file generic drug dosage forms.
• Conduct extensive literature searches on assigned projects.
• Suggest improvements and efficiencies in the department.

Skills

Formulation Development

Process Development

Pharmaceutics

Pharmacokinetics

Teamwork

Communication Skills

Education

MS or PhD in Pharmaceutics

Tools

Fluid Bed Processor

Job description

· Formulator with previous industrial experience developing and filing generic drug dosage forms (orals/liquids)

· Ability to perform extensive Literature Search on assigned Projects.

· Thorough understanding of the ANDA (and preferably NDA) filing process in line with QbD elements in generic product development

· Experience working with projects from bench-top stage to large scale manufacture of submission batches

· Should have a sound knowledge of pharmaceutics, pharmacokinetics and process scale-up

OTHER FUNCTIONS AND RESPONSIBILITIES

Suggest improvements and efficiencies in the department. Assist in revising and maintaining SOPs, operating procedures and other documents.

Suggest new equipment and or training for personnel.

QUALIFICATIONS

Formulation development and process development scientist with 3+ years of experience in the generic drug industry with ANDA filing experience.

REQUIRED

MS or PhD in Pharmaceutics or related field

PREFERRED

Experience in working with DEA controlled drug substances and relevant regulations.

Experience in developing controlled-release product using Fluid Bed Processor (Wurster coating) technology.

Quick Checklist

Qualifications

Candidates will need to have all of the requirements on the job description especially this part:

Formulation development and process development scientist with 3 or more years of experience in the generic drug industry with ANDA filing experience.

Must have ability to work in a team with excellent spoken and written communication skills

Candidates would definitely need Formulation Development and Process Development background. Both are a must.

Additional Information

All your information will be kept confidential according to EEO guidelines.