Director/Senior Director of Biologics

Overview

The Advanced Regenerative Manufacturing Institute (ARMl)IBioFabUSA is a Member-based non-profit organization founded to build the biofabrication industry and transform the future of healthcare. ARMI provides wrap-around commercialization services to companies seeking to bring life-saving regenerative technologies to patients, as well as to innovators seeking to commercialize enabling technologies that will grow the industry's impact.

The Impact That You Will Make

ARMI is in search of a self-starter with demonstrated leadership in the development and optimization of manufacturing processes for recombinant proteins, polysaccharides, or other biotechnology products. This position will initially require the individual to build a new capability within an existing research, development and manufacturing framework that is currently focused on cell therapy production. This new capability will require both strategic and hands-on skills to procure instrumentation to equip a new laboratory, to hire and onboard highly qualified staff, and to lead with urgency the new team in the tech transfer and optimization of existing manual, laboratory-scale processes to scalable production. The position reports to the Chief Technology Officer, but the individual will be expected to work independently and cross-functionally both internally, with Quality Assurance and Quality Control, Operations, Project Management and Finance, and externally with project collaborators and clients.

Your Role

• Leadership & Management: Hire, train, and mentor staff, from the bench as needed, set performance goals, ensure high productivity, and maintain a safe and organized laboratory environment
• Technical Execution & Optimization: Develop, optimize, and scale-up cell culture and downstream purification processes (HIC, SEC, IEX, Affinity chromatography, TFF, depth filtration, lyophilization) using high throughput systems at both bench and pilot scale
• Quality Control: Analyze product purity and quality using a variety of techniques, including SDS-PAGE, capillary electrophoresis, HPLC/UPLC using a variety of separations and detectors, ELISA, colorimetric assays
• Documentation & Compliance: Ensure accurate record-keeping in electronic notebooks (ELN), draft Standard Operating Procedures (SOPs), and ensure team adheres to regulatory/safety standards
• Cross-functional Collaboration: Support upstream cell culture team and downstream purification team, while managing internal interactions and external collaborations

Your Skills and Experiences

• Exceptional interpersonal, written and verbal communication skills
• Experience working in a fast-paced, dynamic, collaborative team environment
• High energy, commitment, initiative, and perseverance
• Education: PhD in Biochemistry, Chemistry, or Life Sciences (5-10 years' experience) or a Master's degree with extensive relevant industry experience (10+ years)
• Deep expertise in cell culture, analytics, troubleshooting, and macromolecule purification (e.g. protein or carbohydrate purification on AKTA or similar systems; specific experience in polysaccharide purification is a significant advantage)
• Demonstrated leadership, team building, and demonstrated expertise executing with urgency in a multi-departmental organization with diverse internal and external stakeholders
• Familiarity with or working knowledge of GMPs is a plus
• Cell culture optimization and scale up in a variety of expression systems (mammalian > E. coli > yeast)
• Downstream purification: AKTA systems, Unicorn software, or equivalent, affinity, ion exchange, size-exclusion, TFF and other isolation and purification technologies
• Analysis: SDS-PAGE, CE, HPLC/UPLC, ELISA, UV-Vis

By applying, I understand that any offer of employment is contingent upon the successful completion of a background check, in accordance with applicable laws.