Associate Scientist, Process Development and Manufacturing
A robust Gene Therapy company headquartered in Cambridge, MA is actively seeking a highly-motivated Associate Scientist to join their Lentiviral Vector Process Development and Manufacturing Team and support the programs within the company's rare disease and oncology pipelines.
- Experience in process automation, data capture, and technology development activities is preferred.
- Design and execute viral vector production and purification to support drug product manufacturing and development.
- Actively contribute to all activities pertaining to novel lentiviral vectors such as laboratory equipment management, mammalian cell culture, buffer preparation, transfection, membrane purification, ultrafiltration, diafiltration, sterile filtration, reagent qualification, and coordination of testing with the PD Vector Analytics team.
- Provide changes to the vector production process as necessary to improve robustness, capacity, and throughput.
- Contribute to the writing, review, and approval of technical documentation including development protocols, reports, batch records, and SOPs.
- Execute process monitoring, process capability, and associated statistical analysis with process trending data.
- M.S. with 0-2 years of experience B.S with 1-3 years of experience
- Academic Degree in Chemical Engineering, Biochemistry, Bioengineering, Molecular Biology, or related field is preferred.
- Proven execution of laboratory experiments, ability to work cross-functionally in a collaborative environment, and excellent written & verbal communication skills
- Working knowledge of process development and pharmaceutical manufacturing for biologics, including cell culture (upstream) and purification (downstream) operations.
- Proficiency with Unicorn/AKTA systems, analytical methods for biologics, or vaccine development is preferred.
- Background in statistical analysis using JMP or Minitab preferred
- Familiarity of working with outside vendors.
- Knowledge of cGMP/ICH/FDA regulations.
Sthree US is acting as an Employment Business in relation to this vacancy.