Business Analyst I
at Townsend & Associates

Date Posted: 4/16/2018

Job Description


Business Analyst I
 
Responsibilities:
  • Compiling data in a spreadsheet format in support of USDA submissions, and auditing of compiled data spreadsheets.
  • Managing sample inventories in support of stability studies.
  • Technical review of analytical procedures, protocols, and reports supporting analytical method validation, analytical transfer, and stability studies.
  • Provide support for execution of experiments related to analytical development, validation, critical reagent qualification, technical transfer, and analytical investigation/troubleshooting under the direction of senior scientists as needed.
  • New Products Development:
    • Support analytical transfers for New Products from the Bio Analytical R&D and other initiating laboratories to the Quality Control Departments of Athens and Gainesville, and external partner laboratories as needed.
    • Contribute to risk mitigation in analytical development by recommending design options and providing QC needs and constraints.
    • Conduct studies at the direction of DIFA management and scientists to guarantee robustness, reliability and regulatory compliance.
    • Support studies to evaluate product stability.
    • Study sample management, data analysis, and data review.
    • Coordinate analytical tools transfer to Merial QC or partners (QG020): preparation of equipment, materials, documentation and training of QC employees.
    • Monitor QC analytical tools of new products for stabilization and optimization after launch, in partnership   with Quality Control.


  • Analytical tools Life Cycle Management:
    • Provide support for existing analytical tools (Trouble Shooting).
    • Improve analytical tools performance based on QC indicators or flow performance analysis.
    • Ensure analytical tools compliance following regulatory evolutions (Ph. Eur, VICH, …), in case of modification of existing tools or transferring new tools from Bio Analytical R&D.

  • Critical reagent process:
    • Contribute to improve current processes and their execution, for reagent sourcing, production, qualification, inventory management.
    • Contribute to scout for new technologies for Antibody and Antigen alternatives.


  • Safety Objectives:
    • Must successfully complete the hazardous waste management-training program within six months of their employment or assignment should this be the case.
    • Employee must not work in unsupervised positions until they have successfully completed the hazardous waste management training requirements and must take part in an annual review in addition to the initial training. 
    • Training program includes classroom instruction and on-the-job training to ensure they perform their duties in compliance with the requirements of the Resource Conservation and Recovery Act, (RCRA).  

  • The Merial hazardous waste management-training program includes all the following elements:
    • All departmental managers and supervisors shall successfully complete training in hazardous waste management and shall provide hazardous waste management training to his or her department’s personnel. 
    • Supervisors and managers will ensure that original documentation of such training shall be placed in the employee file located in the Human Resources Department (HRD) and with a copy of the training documentation submitted to the Health, Safety, and Environmental Department (HSE).
    • Training program includes hazardous waste management procedures which instructs facility personnel hazardous waste management procedures (including contingency plan implementation) relevant to the positions in which they are employed.
    • At a minimum, the training program is designed to ensure that facility personnel can respond effectively to emergencies by familiarizing them with emergency procedures, emergency equipment, and other emergency systems, where applicable.


 

Job Requirements

  • BS or higher in Biochemistry, Biology or similar technical field. 
  • 5-7 years of relevant experience with industrial QC & viral preferred.
  • Immunological methods and western blotting experience.
  • Knowledge of FDA requirements.
  • Knowledge of 9CFR, Outline of Production and Biological Manufacturing testing.
  • Technical writing skills.
  • Project management skills.
  • Proficient computer skills.
  • Previous experience in human biologics would be relevant.
  • Cell culture and virus cultivation experience is preferred.
  • Research & development and QC experience are preferred.


Ref No.:  18-00311

Job Snapshot

About Us

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