Senior Formulation Scientist

This is a Senior Formulation Scientist role in Generic Pharma, product development with 3 5 years industrial experience. This role is very hands-on. Must have experience in development to large scale submission batch manufacture.

• Senior Scientist with previous industrial experience developing and filing generic drug dosage forms (orals/liquids)
• Ability to develop the product using FBD, Compression and Encapsulation
• 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
• 3-5 years of Senior Scientist Formulation development and process development
• 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

• Must be legally able to work in the US without requiring sponsorship

• Must have reliable transportation and must be able to work overtime when required
  

• Perform all other duties as assigned

Education & Experience (Including Certifications, years of experience)

• MS or PhD in Pharmaceutics or related field
• Experience in working with DEA controlled drug substances and relevant regulations.
• Experience in developing controlled-release product using Fluid Bed Processor (Wurster coating) technology.

Physical Requirements (Please select appropriate option)
OFFICE POSITION - While performing the duties of this job the employee is required to: Stand, sit; talk, hear, and use hands and fingers to operate a computer and telephone keyboard reach, stoop kneel to install computer equipment Specific vision abilities required by this job include close vision requirements due to computer work Light to moderate lifting is required Moderate noise (i.e. business office with computers, phone, and printers, light traffic). Ability to sit at a computer terminal for an extended period of time Sedentary work Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.