Job Description
Job Description
GENERAL SUMMARY:
The AD Associate I/II position develops, optimizes, and qualifies analytical methods for biopharmaceutical products. The associate also supports drug development departments, such as Purification Department and Cell Culture Department, by performing analytical testing.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Develop analytical test procedures on biopharmaceutical products including potency testing, SEC-HPLC, RP-HPLC, cIEX, Affinity Chromatography, SDS-PAGE, ELISA, IEF.
- Test new products on existing analytical platform methods including Spectrophotometry, Osmolality, Host Cell Proteins, pH, Conductivity, Endotoxin, and Bioburden.
- Prepares reports on analytical methods with emphasis on critical steps, mathematical calculations, and statistical data.
- Draft Standard Operating Procedures (SOP) with intention to be used in a quality controlled GMP environment.
- Design, draft, execute, and evaluate method qualification protocols in accordance with ICH and FDA guidelines resulting in a well written qualification report.
- Analyze method performance and develop appropriate experiments to help identify and solve any method performance issues.
- Routinely uses analytical equipment such as scales, balances, pipettes, and volumetric containers. Organizes and properly labels samples and sample preparations.
- Perform analytical testing following CGMP guidelines
- Performs analytical testing for support of biopharmaceutical product development
- Maintains accurate records by logging equipment usage, procedures and results in data logs, data sheets and laboratory notebooks.
- Maintains and troubleshoots general laboratory equipment including HPLC and clEF machines.
- Maintains a clean workspace and participates in general housekeeping efforts.
JOB REQUIREMENTS:
- AD Associate I
- BS in a life science field with 1+ years of direct related experience
- MS in a life science field
PHYSICAL DEMANDS:
While performing the duties of this job, the employee is frequently required to stand; sit and talk or hear. The employee is occasionally required to walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance and stoop, kneel, crouch, or crawl.
WORK ENVIRONMENT:
Associate will work in a team setting with an attitude of promoting teamwork by assisting others. Job will take place in a laboratory with limited exposures to hazardous chemicals commonly used in a biochemical/ protein