job summary: Job Responsibilities
Support the development and technical manufacturing of Company's products by evaluating and executing work instructions, manufacturing standards and SOPs utilizing knowledge of biology, chemistry, laboratory equipment and computer software.
Maintain laboratory in proper working order through organization and procurement of supplies, change control and maintenance of laboratory equipment, organization and maintenance of reagents, and general laboratory safety and hygiene. Verify and ensure that proper processes and procedures are followed in accordance with all applicable SOPs.
location: Newark, Delaware
job type: Temporary
salary: $25 - 28 per hour
work hours: 9 to 5
- Perform a variety of moderately complex laboratory techniques
- Perform prep scale column chromatography
- Use of Automated Chromatography equipment (AKTA, FPLC)
- Perform custom formulation of polyclonal antiserum
- Maintain production schedule, notify management of progress
- Maintain accurate and current documentation in accordance with company SOPs and cGMP
- Analyze data and communicate results both verbally and in writing with peers and supervisors
- Troubleshoot equipment and processes. Investigate and properly record process variances
- Write and revise SOPs, deviations and information for completion of CAPA
- Lead team of Production Scientists/biotechnicianss; Provide leadership to team via trainings and coaching
- B.S/B.A. in Biology, Chemistry, Biochemistry, Medical Technology field with 5+years or MS/PhD with 2-3 years of experience
- Knowledge of QSR, cGMP and ISO regulations
- Knowledge of Immunoassay Instrumentation such as Cobas and Hitachi including equipment maintenance and troubleshooting is a plus
- Experience with chromatography techniques used in antibody purification, including SEC, ion- exchange, Protein A and custom affinity. Ability to perform tests including BCA, IEP, RID and Ouchterlony
skills: Biology, Chromatography, Immunoassays, Protein Purification, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.