Process Scientist III

Job Purpose:
This position is responsible for material processing, reagent formulation, technical manufacturing, in-process and final quality control of reagents, components and in-vitro diagnostic products.
 
Essential Functions:

• Produce, test and approve raw materials for immunoassays
• Functional and analytical evaluations of all critical raw materials including: antibody, antigen, serum and particles
• Production of purified antibodies, antigens and conjugates
• Manage raw materials inventories
• Assist with process improvement efforts
• Conduct root cause analysis
• Perform failure mode risk analysis design and execute validate studies
• Create & maintain adequate production & process documentation

 
Minimum Qualifications:

• Bachelors degree in Chemistry, Biology, Medical Technology or related science field or a 2 year degree (i.e. MLT) with equivalent experience
• 4 years of related laboratory experience or demonstrated competence within the in-vitro diagnostic industry
• Comprehensive understanding of immunology and immunoassay technology and systems
• Experience with the in vitro diagnostic or other FDA regulated industry
• Experience with protein purification and assay development
• Experience with electronic inventory and production planning system
• Experience with equipment installation, qualification, maintenance and calibration
• Analytical protein techniques including: gel electrophoresis, size exclusion and reverse phase HPLC, protein conjugation
• In-depth understanding of immunoassay design
• Familiarity with design control requirements
• Knowledge of good manufacturing practices (GMP)
• Knowledge of various lab equipment
• Proven ability to work with minimal supervision
• Working MS Excel knowledge

DiaSorin offers a competitive compensation package to include, medical, dental, employer paid life insurance, employer paid short-term and long-term disability insurance, 6% match of 401(k) plan or Roth IRA plan with immediate vesting.

DiaSorin adopted a policy of providing Equal Opportunity to all employees and applicants for employment in accordance with all applicable Equal Employment Opportunity/Affirmative Actions laws, directives and regulations of Federal, State and Local governing bodies or agencies.