Associate Director/Director, BioProcess Development (DOE)
hace 16 días
Salt Lake City
Job Description Welcome to DiscGenics, a pioneering, late-clinical stage biopharmaceutical company dedicated to advancing regenerative cell-based therapies for patients suffering from degenerative diseases of the spine. Privately held and passionately driven, our mission is to enhance lives by alleviating pain and restoring function through innovative treatment. At DiscGenics, we are committed to improving the quality of life for individuals debilitated by degenerative diseases of the spine. Our focus lies in developing cutting-edge therapies that offer hope and tangible results, fostering a future where patients can regain mobility and comfort. Our team is characterized by a relentless pursuit of excellence and a nimble approach to addressing challenges. Our core values of Integrity, Innovation, Accuracy, Teamwork, and Stewardship guide everything we do. Join us at DiscGenics and be part of a transformative journey where your contributions have the potential to impact the lives of millions. Together we innovate with purpose and compassion, striving towards a future where pain and limitations of degenerative spine diseases are a thing of the past. Discover more about us at discgenics.com and see how you can contribute to revolutionizing patient care through regenerative therapies. This position is onsite at our headquarters located in Salt Lake City, Utah. Job Summary: This position can be Associate Director/Director level depending on the experience of the candidates. The Associate Director/Director, Bioprocess Development oversees the development lifecycle of manufacturing processes through careful organization, skilled execution of individual contributions from the entire BPD team as well as coordination with analytical, validation, MS&T, and quality teams. This role interacts with all levels of the organization in a collaborative and positive way with colleagues to facilitate department and organizational initiatives for cultural cohesion aligned to the DiscGenics Values. Essential Duties and Responsibilities: • Oversee the design, execution, and analysis of process characterization to support the IDCT BLA., • Work with company stakeholders to identify and agree upon necessary process changes and improvements for implementation for and BLA filing and post approval., • Establish comparability strategy inclusive of in vitro and in vivo testing mechanisms., • Develop and improve all necessary models and tools for these assessments inclusive of small scale model., • Develop and organize executional timelines in sync with company objectives and milestones., • Mentor and supervise the work of direct reports including their data and reports and other key deliverables., • Organize and lead team meetings and represent Bioprocess Development in other cross-functional meetings., • Generate and operate within existing budgets., • Design and qualify necessary consumable components., • Management and coordination of process equipment and consumable vendors., • Integrate Quality-by-Design (QbD) principles and participate in risk assessments for the process personnel, and equipment., • Scale up process development for pilot and commercial scale unite operations., • Serve as a technical expert at pilot/commercial scale and assist with technology transfer from process development to cGMP manufacturing., • Assist with or execute development, engineering and cGMP runs in manufacturing environment., • Produce design documents for process consumables., • Generate engineering drawings, technical reports, and other supporting documentation., • Establish vendor sources for all consumables., • Act as a technical liaison for outside functional groups and outside vendors., • Process equipment training for new development staff., • Participate in process equipment design, selection, qualification, maintenance, cleaning, and general lab support as needed., • Data analysis and clear communication of results, including appropriate cGMP documentation for eventual regulatory submissions and inquiries., • Utilize professional experience and understanding of company objectives to resolve complex issues and challenges., • Independently works through complex engineering problems using own judgment to establish appropriate analysis strategies to generate data for successful analysis and resolution., • Determine when necessary to network or consult outside of own expertise to resolve problems., • Perform design of experiment and process characterization of allogeneic cell therapy manufacturing process in preparation for BLA., • Ability to mentor and train individual contributors and upcoming managers., • Highly capable of independent work, thought, and analysis., • Experience in scale up, tech transfer products, and cGMP environments., • Proficiency in bioreactor engineering and bioreactor operation, such as set up, sampling, harvesting, configuration, process control and programming., • Hands on experience with use of single use equipment (bags, connectors, bioreactors, centrifuge) in cGMP environment., • Demonstrated project management experience., • Strong interpersonal, communication (verbal and written) ability., • Independence and creative problem-solving abilities., • Ability to handle highly confidential business information., • Exceptional time management and multi-tasking skills., • Team leadership skills and team player., • Adheres to and leads with the Company Values of Integrity, Innovation, Accuracy, Teamwork and Stewardship., • Regular and predictable attendance., • Ability to report to work responsive, free from sedatives, and in a non-sedative state., • Master’s degree in Bioengineering or related field., • PhD strongly preferred., • 10+ years of progressive leadership experience., • 10+ years of relevant experience in biologics or pharmaceutical engineering. Relevant time obtaining advanced degree may also be considered towards this requirement., • Prior experience and success in execution of process characterization and CMC in cGMP environment., • Experience in the writing and submission of CMC section for BLA Position requires qualified individuals to see, hear and speak (verbally and audibly). Required to ascend and descend stairs; sit, stand, lift, bend, stoop, crawl and kneel. The employee must also use hands to finger, handle or feel. Occasionally reaching with hands and arms, climbing or balancing are required. May be asked to drive or travel by car, air, or other transportation for business purposes. Must be able to lift and carry up to 20 pounds. Must be able to function effectively with noise in a lab environment. Natural and regular stressors occur on the job. Disclaimer: Please note: DiscGenics reserves the right to change, modify, suspend, interpret, or cancel in whole, or in part, any of the duties outlined above, at any time, and without advance notice to the employee.