Imagine… 2 weeks after the birth of your child you realize they aren’t meeting critical developmental milestones and after months of doctor’s appointments you are told your baby has a rare neurological disease that would impact how they would live their lives. This is the reality of parents whose children have Spinal Muscular Atrophy (SMA) and it’s the reason why we at Novartis Gene Therapies are laser focused on bringing hope and possibility to those devastated by rare genetic diseases.
The Director, Laboratory Technical Research & Development, is responsible for leading the laboratory operations in support of process design, experimental design and execution, scale model development and management, investigational testing for cGMP operations support, operational and capital budgeting, laboratory strategic trajectory planning, project planning and execution, laboratory operational systems development and therapeutic product program development support in addition to defining and directing the activity of scientific and engineering staff.
- Executes and documents experimental procedures in support of process development activities supporting investigational, clinical and commercial gene therapy programs including but not limited to new process design and development, process proof of concept through characterization studies in alignment with program strategy, pre-clinical materials generation and documentation, direct clinical and commercial GMP operations support, scale-up studies, raw materials evaluation as well as process optimization and improvement studies.
- Supports laboratory operations process development activities in drug substance (upstream, intermediate and downstream), drug product (formulation, filling, packaging and labeling) and critical raw materials, media and buffer manufacturing.
- Builds and maintains a high performing staff of managers, engineers and scientists to support process and platform development activities.
- Serves as a key scientific and technical representative for process-related issues pertaining to new products as well as licensed products manufactured at internal AveXis sites, as well as with external partners.
- Develops, implements and maintains process development laboratory operations systems that support safe, efficient and compliant work processes, continuous improvement, data integrity and operational excellence.
- Partners with multiple manufacturing organizations to understand operability requirements and potential process improvements for existing and new processes and incorporate those requirements into process design studies.
- Prioritizes and drives a continuously changing portfolio of lab studies within a laboratory network and according to business need while communicating and managing competing priorities leveraging organizational management practices such as personnel loading assessments, capacity evaluations, capital and space planning and organizational design evaluations.
- Oversees the development of experimental procedures that interrogate, define and document Normal Operating Ranges (NORs), Proven Acceptable Ranges (PARs), facility fit assessments, scale-up demonstrations for biopharmaceutical products in upstream, downstream and/or fill finish areas.
- Delivers direct support of pre-clinical, clinical and commercial manufacturing operations through investigational testing of in-process pools, raw material assessments, impurity clearance, adventitious agent clearance and process capability assessments.
- Leverages experimental planning and design practices such as design of experiment (DOE), risk assessment and edge of failure determination to accelerate process development activities.
- Directs support of Pre-Clinical Study material generation including readiness studies prior to manufacture of new molecules on platform processes and phase appropriate documentation development and delivery.
- Leads and manages the establishment, documentation and maintenance of scale models.
- Builds a robust data packages that directly support regulatory submissions for new and approved gene therapy biopharmaceutical products (CMC).
- Reviews and provides feedback and technical/scientific support on project deliverables, i.e. remediation initiatives, plan reports, etc.
- Other related job duties as assigned.
- B.S. degree in biochemistry, chemical engineering, bioengineering, or related technical field and 10 years’ experience in biopharmaceutical based process development and/or cGMP manufacturing operations including direct experience in cell culture, recovery, purification and/or aseptic fill/finish. Master’s degree and 8 years’ required experience or PhD and 6 years’ required experience preferred.
- 7 years leadership experience.
- Experience in direct viral production and purification preferred.
- Excellent oral and written communication skills.
- Familiar with global regulations and regulatory submission requirements (CMC) pertaining to Gene Therapy development and manufacturing.
- Excellent communication skills and attention to details.
- Strong organizational skills and ability to multi task across projects and activities.
- Proven ability to effectively lead and participate on teams.
- Approximately 10% to 30% travel.
The level of this position will be based on the final candidate’s qualifications.