Director of Process Development

Austin, TX, United States
Jun 06, 2021
NextGen Bio
Required Education
Bachelors Degree
Position Type
Full time
Triumvira Immunologics, Inc. ("Triumvira") is an immunotherapy company co-founded in 2015 by Dr. Jonathan Bramson at McMaster University and Bloom Burton & Co., with the vision of developing novel T cell therapies that are safer and more efficacious than current cancer treatments, including chimeric antigen receptor (CAR) and engineered T cell receptor (TCR) therapies. Our proprietary T cell Antigen Coupler (TAC) technology recruits the entire natural T cell receptor and is independent of the major histocompatibility complex (MHC), allowing for the development of better therapies for a broader range of patients with solid or liquid malignancies and also with diseases other than cancer.

General Purpose

To support the Company's vision, mission, and values by demonstrating: excellence and competence, collaboration, innovation, respect, commitment to our community, and accountability.

The Director of Process Development reports to the Chief Technology Officer, is a member of the Operations team, and works in close collaboration with Research & Development staff, Manufacturing staff, Quality Systems, and any outsourced services. The director is responsible for (1) the development and oversight of manufacturing-related process improvements,(2) facilitating development activities related to the expansion of the company's technology platform & other potential technologies, (3) assuring adherence to the applicable regulations and standards (i.e. GMP, GTP, AABB, Quality Systems, and OSHA) and (4) facilitating technology transfer to manufacturing staff. This position coordinates the design, execution, and reporting of experimental designs (DOE), training of personnel, project budgeting as well as preparation of regulatory documents.

This position provides confidence, stability, leadership, and guidance to the development staff, particularly when unscheduled or unplanned events occur, and is accountable for the completion of project goals.

Duties and Responsibilities
The primary duties and responsibilities of this role include the following. Other related duties may be assigned to meet business needs.
  • Direct and oversee a multidisciplinary process development team to develop process improvements for the Company's platform technology as well as evaluation of additional technologies that may be of value to the Company.
    • Assist in and provide input into critical process decisions
    • Provide technical and scientific guidance to team members
    • Evaluate the productivity of cell lines, feed strategies, and process control parameters
    • Work with vendors to assess new technologies
    • Develop and implement new technologies to streamline cell culture process development and manufacturing
  • Ensure that technical procedures are performed under the highest standards of quality in a timely manner while minimizing costs.
    • Work closely with the Chief Technology Officer
      • To establish appropriate activities and timelines in order to achieve corporate objectives.
      • Migrate manufacturing processes to full automation
    • Work in conjunction with the analytical PD team to establish and maintain appropriate performance qualifications for all associated instrumentation, assays, and processes and participate in the validation of assays and processes.
    • Continually monitor results and trends for individual processes
  • Create relevant policies, procedures, batch records, and design of experiments (DOE) records to assure completeness, correctness, and compliance.
    • Compilation and analysis of related data for DOE and comparability studies
    • Comply with Quality Systems documentation. This may include troubleshooting problems, evaluating root causes, and implementing corrective and preventive actions (CAPA) when needed.
    • Participate in the development and writing of regulatory documents
  • Assess and prioritize work schedules in order to achieve the desired milestones with the available resources.
    • Provide assessments of the time and resources necessary for the successful implementation and execution of various projects
    • Collaborate with other staff to ensure adequate availability of supplies and reagents.
  • Facilitate the technical transfer of knowledge, procedures, and process improvements and techniques to manufacturing personnel and other departments as appropriate.
  • Active participation in benchwork as is appropriate
  • Perform other duties as assigned.

Minimum Qualifications

The following are the minimum qualifications and competencies needed in order to successfully perform the duties and responsibilities of this position. The individual may be required to demonstrate proficiency in some of these depending on the department and/ or job functions assigned.

General and technical
  • Skilled in cell culture and aseptic processing; experience in working with closed culture systems, bioreactors, and standard blood banking equipment is preferred.
  • Ability to train others and serve in an advisory capacity to technical staff.
  • Understanding of basic hematology and hematological reconstitution, blood bank practices, immunology concepts, and cGXP requirements.
  • In-depth understanding of cell therapy processing of whole blood, aphaeresis, and other cellular products.
  • Experience with T-Cell immunotherapy and its applicability to both autologous and allogeneic product development.
  • Full understanding of scale-up strategies in manufacturing operations, including transitioning of research techniques from development to production.
  • Working knowledge of policies and procedures related to processes and equipment directly involved in the manufacturing of clinical trial material.
  • Working knowledge of laboratory design, safety rules, universal precautions, etc.
  • Aggressive computer skills and analytical software.

Education, training, and experience
  • MS or Ph.D. with a minimum of 5 years' experience in biological sciences, preferably in an industry environment
  • Prior experience with cGMP cell & gene therapy processes and manufacturing is required
  • Experience in clinical research is preferred, including experience in the manufacture of pre-clinical and clinical products.

Core competencies
  • Analytical analysis of intricate and diverse information.
  • Judgment-exhibits sound judgment and makes timely decisions, escalates issues, and ideas as appropriate.
  • Planning/organizing-prioritizes and plans work activities, uses time efficiently and develops realistic action plans, adapts quickly to changes in the work environment or priorities, effectively accommodates critical time constraints and competing priorities into the work schedule.
  • Problem-solving-identifies and resolves issues in a timely manner, gathers and evaluates information competently.
  • Oral communication-speaks clearly and persuasively in positive or negative circumstances, demonstrates good presentation (training) skills and leads meetings, communicates effectively with personnel at all levels of the organization, communicates effectively (oral and written) with third parties such as vendor representatives and FDA inspectors.
  • Teamwork-is capable of working in a fast-paced environment while interacting effectively in a diverse group.
  • Quality control-demonstrates accuracy and attention to detail, examines own work to ensure excellence, and applies feedback to improve performance, produces accurate results under pressure, or time constraints.