Join the lentiviral vector process development and manufacturing team at bluebird bio! The chosen candidate will have the opportunity to participate in development, scale-up, and PD manufacturing activities for our rare disease and oncology pipelines. We seek candidates with proven ability to successfully work independently and collaboratively across functions to enhance product quality, quantity, and process efficiency. We are passionate about transforming the lives of patients, incredibly cool science, and bird puns.
- Innovation! Creative problem solving is a must-have for this position. Experience with process automation, data capture, and technology development activities preferred.
- Planning and execution of viral vector production and purification to support drug product manufacturing and development.
- Actively participate in all activities related to preparing new lentiviral vectors: 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.
- Implement changes to the vector production process as needed to improve robustness, capacity, and throughput.
- Assist in the writing, review, and approval of technical documentation including development protocols, reports, batch records, and SOPs.
- Perform process monitoring, process capability, associated statistical analysis with process trending data.
- Manage ordering of lab consumables and coordinate off-site testing activities.
- Master’s degree and 0-2 years of directly related experience or Bachelor’s degree and 1-3 years of directly related experience.
- Degree emphasis in Chemical Engineering, Biochemistry, Bioengineering, Molecular Biology, or related field preferred.
- This is a hands-on position requiring conducting laboratory experiments, good documentation skills, good writing skills, and the flexibility to move between the planning and execution of each required function as needed.
- General knowledge of process development and pharmaceutical manufacturing for biologics, including cell culture (upstream) and purification (downstream) operations.
- Familiarity with Unicorn/AKTA systems preferred.
- Familiarity of analytical methods for biologics or vaccine development preferred.
- Experience in statistical analysis using JMP or Minitab preferred
- Strong organizational skills. Familiarity with the 5S methodology is a plus.
- Experience in working with outside vendors.
- Knowledge of cGMP/ICH/FDA regulations.
- Track record of completing deliverables within specified timelines.
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment. Ability to work effectively in a cross-functional team.
- Self-motivated with a “do-what-it-takes” approach to problem solving.