The Process Sciences Leader is a critical role within the Manufacturing Science and Technology (MS&T) Function. This individual has overall responsibility for technical product lifecycle management for several assets in Spark’s growing pipeline of gene therapies. This includes oversight and management oftechnology transfer(new product introductions) into Manufacturing. Developing Life Cycle strategies and plans, including clinical and commercial phases, process improvements and post approval commitments. The individual will be accountable for the successful execution of the corresponding plans in compliance with Agency and Industry Guidance. During the clinical/commercial manufacturing preparation phase,
this role will lead the delivery of all pre-run deliverables such as Materials List, Process Transfer Documents, Manufacturing Batch Records, Process Monitoring plans, etc.
- During the clinical/commercial manufacturing execution phase, this role will lead manufacturing investigations related to product impact, change control justifications, and implementation related to process and equipment adequacy and efficiency, process monitoring, and general troubleshooting.
- During the Campaign Close-out phase, this role will ensure all technical deliverables are completed to release product and prepare for Shutdown or Product Changeover
The successful Process Science leader will be viewed as the primary manufacturing science technical resource for the organization.
Realization of objectives is expected to be through a combination of individual contributions, direct and dotted line management of junior staff.
This role will report to the MS&T Lead within the Manufacturing Organization.
Job Function and Description
For the products and assets in development assigned to the Process Sciences Leader (PSL):
Education and Experience Requirements
- Serve as the Technology Transfer Process Team Lead
- Be the primary interface between, Process Development, Analytical Sciences, QA/QC, Materials Management and Facilities & Engineering.
- Lead and manage the authorship of Technology Transfer Procedures, Manufacturing Batch Records, Process SOPs, Process Characterization, Validation Protocols, Process Characterization Summary Reports, and any process related compliance documents.
- In collaboration with Process Development, evaluate and propose changes to process/technology to improve compliance or efficiency. Implement strategies relating to new process improvements and capital investments.
- Responsible for all aspects of process validation including: Process Characterization, Process Validation and Continued Process Verification
- Design characterization protocols as needed, and oversee that Process Monitoring regulatory requirements are being met.
- Write, Review and manage deviations pertaining to manufacturing processes, facility, and raw materials for both internal and external manufacturing.
- Lead Root Cause Analysis and Risk Assessment Programs and address gap assessments in preparation for GMP Manufacturing, Agency interactions and Inspection Readiness.
- Lead any Manufacturing Change Controls, Validation protocols, and CAPAs.
Key Skills, Abilities, and Competencies
- BS/MS/PhD in Life Science/Engineering or related field required.
- Minimum 5-8 years of experience in the Biotechnology or Pharmaceutical industry in leadership roles.
- Experience in biopharmaceutical based GMP manufacturing science and technology including direct experience in gene therapy, cell culture, recovery, and purification.
- Demonstrated technical project management experience to develop project goals, deliverables, and timelines.
- Experience with accelerated CMC development pathways a plus
- Knowledge of GxP compliance
- Experience managing CMO/CDMOs preferred.
Complexity and Problem Solving
- The position requires extensive knowledge and experience with cGMP upstream and downstream manufacturing of biopharmaceuticals or biologics and the life cycle management of these processes. Experience with virus or vaccine manufacturing a plus.
- Demonstrated ability to lead matrix technical teams to achieve objectives. Acts to promote a productive and cooperative climate. Helps to promote team effectiveness by engaging in a trusting, supportive partnership with others. Respectfully holds self and team members accountable to goals and metrics. Facilitates a beneficial resolution of competing objectives and technical differences, transparently and in a timely manner. Resolve conflicts in a constructive manner that allows win/win solution, when possible and in effective tradeoff decision cycles when necessary.
- Demonstrated ability to prioritize and coordinate activities within and across work groups; able to anticipate priority differences and issues and resolves these before problems occur, exceeds desired results.
- Participates in the budget development process; effectively controls the controllable expenses (OT, Supplies, T&E) within their influence.
- Experience with Pharm 4.0 concepts, JMP, Process Informatics, Microsoft Project, process mapping and Lean management tools a plus.
- Should have high organization and situational awareness and be skilled in the craft of communication in all forms, to all levels of the organization.
Internal and External Contacts
- Demonstrated ability to manage an appropriate level of risk in technical and project management realms.
- Able to lead technical teams in the development and evaluation of new technology, and subsequently prepare business plans to enable life cycle development.
- Ability to prepare contingency plans and logically work through complex technical issues in a pressure filled atmosphere
- Ensure resolution to all organizational, technical and product lifecycle management issues.
- Erroneous decisions or failure to achieve results may have significant financial implications or cause delays in schedules.
Accountable to Technical Development & Operations
Internal Contacts – Manufacturing Operations, QC, QA, Facilities, Process and Analytical Development
External Contacts – Raw Material Vendors, CMO/CDMO relationships, and Partnerships.
Please be aware that Spark mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.
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Join the Spark Team
We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable - until now.
We don't follow footsteps. We create the path.