Senior Director of Biologics

Advanced Regenerative Manufacturing Institute • Manchester, NH

1d

About The Position

The Advanced Regenerative Manufacturing Institute (ARMI)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. 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.

Requirements

• Exceptional interpersonal, written and verbal communication skills
• Experience working in a fast-paced, dynamic, collaborative team environment
• High energy, commitment, initiative, and perseverance
• 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
• 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

Nice To Haves

• Familiarity with or working knowledge of GMPs is a plus

Responsibilities

• Hire, train, and mentor staff, from the bench as needed, set performance goals, ensure high productivity, and maintain a safe and organized laboratory environment
• 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
• 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
• Ensure accurate record-keeping in electronic notebooks (ELN), draft Standard Operating Procedures (SOPs), and ensure team adheres to regulatory/safety standards
• Support upstream cell culture team and downstream purification team, while managing internal interactions and external collaborations

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree