Chemistry Analyst

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status. 

Kedrion Biopharma is a biopharmaceutical company specializing in the development, production and distribution of plasma-derived products. Kedrion has been producing plasma products for over 40 years and has a market presence in about 100 countries. Our employees are committed to the highest standards and therapies for the patients and clinicians in hematology, immunology, neurology, and transfusion medicine. 

 Performs general to moderately technical chemistry duties in testing of in process samples, raw materials, finished products, stability, and process validation samples; completes pertinent documentation associated with activities; and performs related duties as assigned. 

Main Responsibilities:

This list is intended to provide a representative summary of the major duties and responsibilities. Incumbent(s) may be assigned certain tasks as the primary responsibility but will also be expected to support other described functions as necessary.

• Support laboratory management by contributing with:
  1. Conduct housekeeping (e.g., QC Fridges/Incubator, bench top surfaces, Equipment, glassware cleaning)
  2. Perform weekly reagents check and reagent inventory for reorder
  3. Equipment calibration/PM (balance, pipettes)
  4. Conduct monthly safety walk thru inspection and Eyewash station check
  5. Ship samples to external vendors, Testing laboratories
  6. Provide general support for reagent preparation, purchase order, sample, and reagents receipt.
• Execute chemical techniques applied to in process samples, characterization samples, raw materials etc.:
  1. pH / conductivity 
  2. Assay Testing (Conductivity, BIORAD, Biuret, TOC, NepH, YM, FTIR) 
  3. Raw Materials Testing
  4. Assay Testing (FVIII, CAE)
• Documentation tasks:
  1. Logbook Review (Balance, equipment usage, sample etc.)
  2. Initiate Lab Investigations & Lab Events
  3. Initiate Deviations
  4. Enter data for Trending (control, release data, Lab events)
  5. Raw Materials compendial review
  6. Perform SOP review as needed
  7. Ensure compliance with training protocol and keep training binder updated
• Complies with safety practices; ensures the collection and proper disposal of hazardous waste from laboratory instruments.

Measurement of Performance

• Generates and maintains a positive, professional attitude toward work and willingness to cooperate with co-workers and supervisors
• Demonstrates timeliness and accuracy in completion of assigned tasks 
• Demonstrates understanding and adherence to Kedrion policies, safety procedures and the cGMPs
• Demonstrate flexibility and adaptability that enhances a successful team-oriented environment under very dynamic conditions

Qualifications

• Bachelor’s Degree in Chemistry or Biological Sciences.
• Previous experience in chemical techniques is preferred.
• Previous experience in Quality control or in GMP environment is preferred. 
• Good written and verbal communication skills.
• Good organizational skills.
• Skilled use of Microsoft Office Suite

Note: This position may require the labeling, packaging or movement of hazardous (flammable, corrosive, toxic, etc.) waste within the facility. If so, this employee would be trained.  In lieu of HAZWOPER training, the employee will receive training on the requirements of the New York State hazardous waste management regulations pursuant to 6 NYCRR §373-3.2.  All employees that have received the above mentioned training within the first six months of hire will receive annual refresher training that covers the OSHA HAZWOPER standard and the personnel training requirements of the NYSDEC