Bioprocess Engineer, Produt Development
[Note: Bioprocess Engineer levels will be determined by education, years of experience as well as mastery of skills.]
The Bioprocess Engineer will support the development and characterization of various biologics cell culture processes from the laboratory through Phase I cGMP manufacturing scale in our biosimilar and biodefense development program.
• Execute bioreactor experimentation to support the development of mAb products, including solution and assembly preparation.
• Analyze and interpret data, investigating unexpected results.
• Documentation of experimental activities.
• Routine cell culture passaging.
• Draft data capture records and work instructions as assigned.
• Maintain up-to-date laboratory notebooks.
• Assist in Recruits, interviews, hires, and training new staff.
• Assist in procedural improvement efforts.
• Perform other related duties as assigned.
• Experience in cell culture including mammalian cell culture of NS0, CHO, and HEK 293 or other immortalized cell lines, selection of stable cell lines, and adaptation/scale-up of cell lines from transfection through shaker culture to small-scale (40 L) bioreactor.
• Experience with cell culture process development (medium development, feed formulation, culture growth conditions).
• Hands on experience with single use bioreactors and/or miniature bioreactors.
• Strong knowledge of Good Laboratory Practices (GLP) and current Good Manufacturing Practices
• Excellent verbal and written communication skills.
• Excellent organizational skills and attention to detail.
• Excellent time management skills with a proven ability to meet deadlines.
• Strong level of initiative and quest for knowledge.
• Ability to function well in a fast-paced and highly productive environment.
• Familiarity with Microsoft Office Suite.
• Bachelor diploma or higher in engineering.
• 2+ years of relevant experience.
BioFactura develops and commercializes biodefense drugs, novel drugs, and high‐value biosimilars (i.e., follow‐on biologics or generic biopharmaceuticals) using its patented StableFast™ Biomanufacturing Platform, the optimal choice for bringing these products to
market with faster, lower cost, superior‐quality manufacture. For over 10 years, BioFactura has been advancing life‐ saving medicines from the research bench to the patient using its innovative drug development and manufacturing technologies. Current and past programs include biodefense drugs against smallpox and Ebola, novel medicines for cancer, and low‐cost/high‐
quality biosimilars for autoimmune and infectious diseases.