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Analytical Industrialization Associate
Ref No.: 17-00148
Location: Athens, Georgia
Responsibilities for this position include the following:
1) Compiling data in a spreadsheet format in support of USDA submissions, and auditing of compiled data spreadsheets.
2) Managing sample inventories in support of stability studies.
3) Technical review of analytical procedures, protocols, and reports supporting analytical method validation, analytical transfer, and stability studies.
4) 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.

Major responsibilities:
1/ New Products Development (Athens and Gainesville):
  • 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.
  • To contribute to risk mitigation in analytical development by recommending design options and providing QC needs and constraints
  • To conduct studies at the direction of DIFA management and scientists to guarantee robustness, reliability and regulatory compliance.
  • To support studies to evaluate product stability
  • Study sample management, data analysis, and data review
  • To coordinate analytical tools transfer to QC or partners (QG020): preparation of equipment, materials, documentation and training of QC employees
  • To monitor QC analytical tools of new products for stabilization and optimization after launch, in partnership with Quality Control.
2/ Analytical tools Life Cycle Management (Athens and Gainesville)
  • To provide support for existing analytical tools (Trouble Shooting)
  • To improve analytical tools performance based on QC indicators or flow performance analysis
  • To 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
3/ Critical reagent process (Athens and Gainesville)
  • To contribute to improve current processes and their execution, for reagent sourcing, production, qualification, inventory management
  • To contribute to scout for new technologies for Antibody and Antigen alternatives
Skills
Safety Objectives:
This position may require the handling, storing, and managing of hazardous waste and this employee shall comply with all applicable state and federal laws. This person must successfully complete the hazardous waste management-training program within six months of their employment or assignment should this be the case. Such an 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. This 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 company 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).
  • The 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 are able to respond effectively to emergencies by familiarizing them with emergency procedures, emergency equipment, and other emergency systems, where applicable.
Education:
Knowledge and skills:
  • BS or higher in Biochemistry, Biology or similar technical field. 5-7 years of relevant experience preferred.
  • Knowledge of 9CFR, Outline of Production and Biological Manufacturing testing
  • Independent decision making abilities
  • Ability to work in team environment
  • Technical writing skills
  • Strong Organizational and Time Management Skills-Project management skills
  • Problem solving skills
  • Proficient computer skills
  • Cell culture and virus cultivation experience is preferred