Scientist, Formulation Development
JOB SUMMARY
REPORTING RELATIONSHIPS
This role reports to the V.P. RD Orals
This role has no direct reports
DUTIES & ESSENTIAL JOB FUNCTIONS
· 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
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.
All your information will be kept confidential according to EEO guidelines.
Job details are sourced from the employer's original posting.
Open job postingAbout the company
Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.