Description

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. Assist in the set-up and maintenance of QC lab, QC support testing, and associated documents.

2. Support the tech-transfer and process scale-up. 

3. Responsible for following cGMP in carrying out functions related to QC testing.

4. Functions may include but not limited to activities such as Spectrophotometry, qPCR, ELISA, HPLC, Endotoxin, review of generated data, development of procedures.

5. Develop and lead optimization initiatives to improve QC department.

6. Develop a high level of knowledge in gene and cell therapy, sensitive in the field of plasmid DNA and other novel products development and manufacturing.

7. Perform other duties as assigned based on business needs.

8. Up to 10% traveling to support CDMO projects or business development activities.

Requirements

1. Master’s degree with 3 years of relevant work experience, or Bachelor’s degree with 5 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. Experience working with Spectrophotometry, qPCR, ELISA or HPLC a plus.

3. Experience in process development and assay optimization for scale-up manufacturing with GMP requirements, familiar with small-scale models troubleshooting approach. 

4. Familiar with process of growing plasmid DNA by microbial fermentation, lysis and chromatography purification process steps. 

5. Experience in authoring, revising, and reviewing documents is a plus.

6. Experience with Laboratory Information Management Systems (LIMS), or relevant data management software.

7. Ability to problem solve, and work independently and as part of a team.

Strong interpersonal, verbal, and written communication skills.