Formulation Chemist
Aurora Pharmaceutical - Northfield, MN

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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-down process models. Other duties include process optimization and product enhancement activities.

Job Responsibilities:

( Essential job functions noted*)
  • Formulates new products, from development to commercialization, within defined company, industry, and regulatory parameters*
  • Establishes guidelines and criteria for acceptance and testing of chemical raw-materials in finished blends*
  • Evaluates raw materials*
  • Develops specifications for new and/or reformulated product*
    • Changes existing formulations to improve product cost*
    • Tests formulations using assays*
    • Conducts stability studies on formulations*
    • Performs scale up for transition to manufacturing*
    • Defines and recommends product and package development activities necessary to meet the Company’s development and commercial needs, including design and execution of required experimental protocols for successful product registration.*
    • Write descriptive protocols that can be used to produce the developmental plans and necessary documents for manufacturing feasibility*
    • Establishes documentation procedures compliant with FDA*
    • 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.*
    • Creates Project Timelines in accordance with Marketing priorities, sets milestones/critical path and ensures on time project completion.*
    • Operates within company’s Quality Management System *
      • 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*
      • Collaborates in cross functional teams*
      • Consistently enforces all company policies & procedures. *
        • Performs additional special projects as assigned.
        • Evaluates & develops new technologies related to pharmaceutical processing*
        • Meets the following physical requirements: *
          • Sits, stands, walks 90% of the time
          • Lifts or pushes a cart with 20-70 lbs, as needed
Qualifications- Education and Experience
  • Masters degree or PhD in Chemistry
  • 5-7 years technical experience in chemical or 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.
Job description is subject to change at the sole discretion of Aurora Pharmaceutical, LLC.

If interested in the position please send resume to Hrdept@aurorapharmaceutical.com

No calls please. Relocation expenses are not available.

Aurora Pharmaceutical - 17 months ago - save job