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 to 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 II
- BS in a life science field with 3+ years of direct related experience
- MS in a life science field with 1+ years of direct related experience
- Must be able to work full-time and the occasional nights and weekend
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 team work by assisting others. Job will take place in a laboratory with limited exposures to hazardous chemicals commonly used in a biochemical/ protein chemistry research laboratory.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state, or local protected class.
Cytovance Biologics acknowledges that providers may be a valuable resource for identifying and recruiting Candidates for employment. However, we require that all external recruiters engage directly with Cytovance Biologics Human Resources Team and comply with Cytovance Biologic's requirements prior to transmitting any Resumes/CV's or introducing any candidates to an employee of Cytovance Biologics. Cytovance Biologic's Human Resource Team is the only function within the Company that can enter contractual relationships with external recruiters and recruiting agencies.