Manager​/Senior Manager, Bioprocess Development; DOE

Position: Manager/Senior Manager, Bioprocess Development (DOE)
Welcome to Disc Genics, 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 Disc Genics, 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 Disc Genics 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  and see how you can contribute to revolutionizing patient care through regenerative therapies.

This role will be at a manager or senior manager level depending on the experience of the candidate. The Manager/Senior Manager, Bioprocess Development will execute and oversee the Bioprocess Development Group responsible for process definition, characterization, scale up and technology transfer of Disc Genics cell therapy manufacturing processes. This is accomplished by skilled execution, careful organization or individual contribution and supervision of assigned bioprocess development team members as well as coordination with analytical method development, raw material development, validation, manufacturing and quality teams.

Responsibilities:

• Supervise biprocess development team responsible for process definition, characterization, scale up and technology transfer of Disc Genics cell therapy manufacturing processes.
• Act as CMC process lead to ensure regulatory compliance of cell therapy manufacturing processes.
• Define, author and review CMC documentation, inclusive of Quality by Design documents, SOPs, protocols, technical reports and risk assessments.
• Organize and oversee all bioprocess studies executed in small scale and pilot scale models to support process definition, characterization and product investigations.
• Develop and organize executional timelines in sync with company objectives and timelines.
• Define and lead meetings to ensure cross-functional communication. Present data updates, strategic plans, timelines and staff updates to executive team.
• Participate in authoring intellectual property, conference abstracts, invited lectures and peer-reviewed articles.
• Develop and operate within budgets. Liase with finance to support funding department activities.
• Mentor and supervise the work of direct reports including study design, data analysis and technical reports.
• Manage bioprocess development small and pilot scale laboratory operations including equipment procurement and maintenance and raw material sourcing.
• Management and coordination of process equipment and consumable vendors.
• Support equipment procurement and qualification activities including equipment design (URS and FRS) and protocols (IOQ) and execution.
• Design and qualify bioprocess consumables.
• Establish vendor sources for key raw materials and consumables.
• Serve as a process technical expert and assist with technology transfer from process development to cGMP manufacturing.
• Provide technical support of clinical, PPQ and commercial manufacturing.
• Act as a technical liaison for outside functional groups and outside vendors.
• Work with outside vendors to design and execute compliance related testing on final product, raw materials, and process consumables.
• Determine when necessary to network or consult outside of own expertise to resolve problems.

Job Requirements:

• 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 a 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.
• Adhere 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…