Formulation Chemist will be responsible for developing new products from concept to commercialization that support company growth. Position will also enhance and improve upon current products. Serves as a technical expert that supports product improvements, quality improvements, customer requests, and cost savings initiatives. Is responsible for formulation and generation of representative pilot samples for internal and external customer evaluations through the use of appropriate scale-up process models.
( Essential job functions noted*)
Qualifications- Education and Experience
- Formulates new products, from development to commercialization, within defined company, industry, and regulatory parameters*
- Evaluates raw materials*
- Establishes specifications for new and/or reformulated product*
- Creates Project Timelines in accordance with Marketing priorities, sets milestones/critical path and ensures on time project completion.*
- Conduct patent searches to determine freedom to operate with a new formulation.
- Participates in team driven activities to facilitate on- going production improvements or new product development projects.*
- Promotes a positive can-do attitude*
- Communicates effectively and consistently in writing and verbally with all levels of staff*
- Consistently enforces all company policies & procedures. *
- Meets deadlines
- Meets the following physical requirements: *
- Sits, stands, walks 90% of the time
- Lifts or pushes a cart with 20-70 lbs, as needed
- Changes existing formulations to improve product cost*
- Performs scale up for transition to manufacturing*
- Develops new technologies related to pharmaceutical processing*
- Writes necessary documents for manufacturing feasibility*
- Evaluates technologies brought from third parties*.
- Prepares product registration documentation and product chemistry packages to meet regulatory requirements. *
- Responsible for batch production from pilot scale to process validation.*
- Performs additional special projects as assigned.
This job description is subject to change at the sole discretion of Aurora Pharmaceutical.
- BS in Chemistry
- 5years experience in pharmaceutical manufacturing
- Proven problem solving skills and track record of successful technical accomplishments
- Strong understanding of cGMP guidelines and FDA regulations related to the pharmaceutical industry *
- Proficient using MS Office applications.
- Experience with FDA and other regulatory agency requirements
- Experience with ANDA, ANADA, IND, and INAD submissions helpful.