Assay Development Associate

Immediate Opportunity! Excellent Pay! Amazing Benefits!
This Jobot Job is hosted by: Juan Correa
Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.
Salary: $80,000 - $110,000 per year

A bit about us:

We develop innovative gene therapies to treat cancer and prolong patient survival.
We synergistically kill tumors while activating the immune system to fight the patient’s cancer, combined with the integration of novel companion diagnostics positions us on the cutting edge of cancer immunotherapies and emerging clinical-stage cancer companies.

Why join us?

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Life insurance

Job Details

General Job Description/Team Overview:
The Assay Development Associate will work independently to develop new assays, optimize existing assays, and perform qualification activities under the QC supervisor/manager’s guidance. This position will also occasionally participate in QC-specific activities, including but not limited to release, stability testing of DS and DP material, in-process sample testing, raw material testing, etc. This position will also involve drafting Assay Development reports, assay optimization reports, and assay qualification protocol/reports, and occasionally will participate in drafting investigation and study reports as instructed and assigned by the QC manager.
Primary Duties and Responsibilities (include but are not limited to):
 Establish, qualify, and maintain cell lines and primary cells for cell-based assays.
 Assay development and optimization on cell-based assays, flow cytometry, FACS, PCR assays, RNA/DNA isolation, and extraction efficiency optimization.
 New assay implementation for product characterization.
 High throughput Assay Development for process science samples.
 Responsible for assay transfer (potentially co-qualification) into QC and provided technical support as needed.
 Responsible for training QC analysts on the new assays.
 Will be participating in assay qualification and validation activities.
 Draft Assay Development report, assay optimization report, assay qualification protocol, and report.
 Draft standard test methods and standard operation procedures for new assays.
 May perform routine DS and DP release and stability testing as assigned.
 Serve as subject matter expert or technical lead for investigational projects.
 Perform any other duties assigned by QC management.
Job Description:
Assay Development Associate
Required Qualifications:
 MS or above in Biology, Biochemistry, or related discipline.
 Minimum of 5 years of hands-on proficiency in cell culture technique or gene therapy product industry.
 Strong experience and knowledge of molecular biology-based analytical procedures.
 Strong cell-culture experience and knowledge.
 Strong Assay Development skills.
 Strong ability to effectively handle multiple projects simultaneously.
 Process critical thinking, initiation, and management of success and failure of complex projects.
 Strong at time management.
 Good team player.
 Proficient in computer skills, including Microsoft Office (Word, Excel, PowerPoint) and others.
 Excellent organization skills with attention to detail and accurate record keeping.
 General knowledge of Federal and State regulatory requirements in a GxP environment.
 High degree of discretion in dealing with confidential information.
 Ability and willingness to work flexible hours when needed.
 Demonstrated ability to work independently and in a team environment.
 Excellent written, verbal, and interpersonal communication skills.
 Eligible to work in the U.S.
Interested in hearing more? Easy Apply now by clicking the "Apply Now" button.