This job is responsible for manufacturing products using instruments and biochemical processes. The incumbent will utilize techniques such as size exclusion chromatography purification/analysis, oligonucleotide deprotection/conjugation, gel filtration, centrifugation, spectrophotometry, reconstitution, and various assays.
DUTIES AND RESPONSIBILITIES:
Quantify protein concentrations utilizing techniques such as spectrophotometry or BCA Assay
Run assays to quantify biotin/protein ratios or glycerol content in solution
Manufacture customer contract materials with specialized procedure and handling requirements
Assist the Supervisor in training of new manufacturing personnel
Review production records to ensure technicial accuracy and compliance with GDP
Maintain preventative maintanence schedules for lab equipment
Provide input and execute tasks to improve routine manufacturing processes that provide for better quality and quantity of products
Update Standard Operating Procedures or Batch Records as needed
Participate in technicial transfer of new processes into the Biochemical Manufacturing team by providing feedback on draft documents and shadowing new production processes during development.
EXPERIENCE AND QUALIFICATIONS:
KNOWLEDGE, SKILLS AND ABILITIES:
Ability to follow laboratory safety instructions; ability to use protective equipment.
Ability to multi-task and work productively in a demanding manufacturing environment with changing priorities
Knowledge of cGMP and/or ISO certification highly preferred
Ability to learn additional software applications/tools, as required
Knowledge of JDE is highly preferred
Knowledge of FPLC or HPLC highly preferred
Knowledge of Akta systems highly preferred
Standard industrial laboratory environment