QC Associate Scientist

Job Scope:

The position reports to the Sr. QC Manager, is ideally suited for a professional with technical knowledge, and exposure to developing and carrying out processes, that are suitable for use in GMP manufacturing of a wide range of clinical trial materials, and participating in the technology transfer.  There is a great opportunity to learn this function within a CDMO business, to support a broad portfolio and advance the manufacturing capabilities to deliver products to the client projects that transform the lives of patients.

1. Perform a wide range of analytical tests, including but not, UV-Spectrophotometry, qPCR, ELISA, HPLC, Endotoxin, MicroBCA, Electrophoresis, and DNA Sequencing/Analysis.
2. Support QC-Analytics initiatives including equipment qualification, method development, method validation, and tech-transfer. Execute protocols related to QC-Analytic initiatives.
3. Ensure compliance with cGMP and regulatory requirements.
4. Develop and lead optimization initiatives to improve QC department.
5. Responsible for following cGMP in carrying out functions related to QC testing.
6. Perform other duties, as assigned based on business needs.

Qualifications: 

1. Bachelor’s degree with 1-2 years of relevant work experience. Degree in Molecular Biology, Biochemistry, Microbiology or related scientific field. Experience in gene and cell therapy recombinant plasmid DNA products a plus.
2. Experience working with QC intermediate and release testing, raw material testing, or validation testing.
3. Experience working with Electrophoresis, UV-Spectrophotometry, HPLC, qPCR, ELISA or DNA Sequencing/Analysis.
4. Experience testing plasmid DNA. Experience testing viral vectors is a plus.
5. Familiar with principles of Good Documentation Practices, Data Integrity, ALCOA+
6. Experience following Standard Operating Procedures or protocols
7. Ability to problem solve, and work independently and as part of a team. Emphasis on the ability to work in a team atmosphere.
8. Experience with Microsoft Office tools. Experience with statistics, coding, programming, troubleshooting, and/or data management software is a plus.
9. Strong interpersonal, verbal, and written communication skills.
10. Exposure to documentation life cycle, by way of authoring, reviewing and/or approving GMP documents, such as procedures, test methods, protocols, reports, etc.

#PB