QC Scientist - Analytics

Position Overview: 

The position reports to the Sr. QC Manager, is ideally suited for a professional with extensive technical knowledge, and a proven track record of 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 lead and evolve 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. Support in the set-up, development and maintenance of a GMP QC-Analytics Lab
2. Support QC-Analytics initiatives including equipment qualification, method development, method validation, and tech-transfer. Execute protocols related to QC-Analytic initiatives.
3. Perform a wide range of analytical tests, including but not, UV-Spectrophotometry, qPCR, ELISA, HPLC, Endotoxin, MicroBCA, Electrophoresis, and DNA Sequencing/Analysis
4. Ensure compliance with cGMP and regulatory requirements.
5. Develop and lead optimization initiatives to improve QC department.
6. Responsible for following cGMP in carrying out functions related to QC testing.
7. Perform other duties, as assigned based on business needs.
8. Up to 15% traveling to support CDMO projects or business development activities.

Qualifications: 

1. Bachelor’s degree with 3 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 Electrophoresis, UV-Spectrophotometry, HPLC, qPCR, ELISA or DNA Sequencing/Analysis.
3. Familiar with principles of Good Documentation Practices, Data Integrity, ALCOA+
4. Experience following Standard Operating Procedures or protocols
5. Ability to problem solve, and work independently and as part of a team.
6. Experience with Microsoft Office tools. Experience with statistics, coding, programming, troubleshooting, and/or data management software is a plus.
7. Strong interpersonal, verbal, and written communication skills.
8. Experience working with QC intermediate and release testing. Experience working with HPLC, qPCR, ELISA and/or DNA Sequencing/Analysis.
9. Experience with Quality Management Systems and Investigations.
10. Experience with governing regulatory bodies, such as FDA, ICH, and EU Annex 1. Experience with lab audits is a plus.
11. Experience with documentation, by way of authoring, reviewing and/or approving GMP documents, such as procedures, test methods, protocols, reports, etc.
12. Experience with Laboratory Information Management Systems (LIMS), or relevant data management software.
13. Experience as a trainer is a plus.
14. Ability to problem solve, and work independently and as part of a team.
15. Strong interpersonal, verbal, and written communication skills.

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Last updated on Aug 27, 2024