Process Development Chemist

Miami, FL

Posted: 03/09/2019 Job Number: JN -032019-10527
Process Development Chemist

SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.
  • Title: Process Development Chemist
  • Location: Southwest Miami, FL
  • Industry: Pharmaceutical
  • Hours: Monday Friday, 8am-5pm
  • Salary: $25.00/hr-$28.00/hr
  • Employment Type: contract position
Job Summary/Objective
Assist in process development activities of new products for non-clinical to commercialization with adherence to Current Good Manufacturing Practices (cGMPs). Gather data from Design of Experiments (DOEs) and provide statistical analysis in assessing process performance. Perform calculations of DEA controlled substances.
Essential Functions
  • Assist in the development and coordination of experiments, including but not limited to DOEs to characterize and improve processes.
  • Assist in process development for blending, coating, slitting and packaging of new products for Product Development.
  • Compile data from DOEs and provide statistical analysis in assessing process performance.
  • Perform drug calculations for controlled substances.
  • Develop protocols, batch records, procedures to ensure successful project execution.
  • Apply cGMPs as related to process design to ensure FDA compliance.
  • Assist during product/process design and re-design in an effort to reduce costs to optimize technology transfer.
  • Interface with Engineering, Validation, Production, and customers to troubleshoot production processes and equipment issues.
  • Work on special projects as required.
  • Meet medical requirement for personal protective equipment (PPE) used during manufacturing.
Competencies
  • Ability to ascertain that work complies with approved Standard Operating Procedures and meets all company guidelines.
  • Good written and verbal communication skills; highly organized.
  • Candidate must demonstrate computer skills with knowledge of office applications software, Mini Tab and enterprise software
  • Attention to detail, ability to speak, read and writes in the English language.
  • Demonstrate the ability to perform statistical analysis using Mini Tab.
  • Employee must demonstrate the ability of adhering to stringent cGMP and DEA documentation requirements.
  • Employee must have good interpersonal skills to interface with other internal groups.
Other Elements
Education & Experience:
  • BS degree, Chemical Engineering or Chemistry preferred, with five years of relevant pharmaceutical experience required.
  • Knowledge of manufacturing processes steps and quality standards
  • Experience with DOE and writing
  • Knowledge of Six Sigma and statistical tools.
EOE/ADA
Search words: Engineer, Chemist, Scientist, DOE, Six Sigma, GMP, FDA, validation, processes, manufacturing, processes
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