The Manufacturing Science and Technology (MS&T) Lead has overall responsibility for establishing an organization to deliver Technical Product Lifecycle Management (DS&DP) for Spark’s growing pipeline of gene therapies. This includes the oversight and management ofall technology transfer
(new product introductions and process improvements) into Manufacturing as well as setting up, recruiting for and leading a lab function to support the manufacturing efforts at Spark and supplemental support as needed for our external manufacturers. The MS&T lead will be responsible for authoring and reviewing relevant sections of regulatory dossiers as well as answering any questions stemming from these regulatory filings. Scope of responsibilities include but are not limited to: deviation support, process control strategy development, validation supporting studies as well as process robustness. This role is also accountable for process and material characterization, process data management/intelligence and process validation.
- During the manufacturing preparation phase, this role will lead the delivery of all pre-run deliverables such as Materials List, Process Transfer Documents, NORs and Targets for process control parameters in the Manufacturing Batch Records, Process Monitoring plans, etc.
- During the 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
- Throughout all phases, this position will lead the Root Cause Analysis program, continuous improvement and process improvement opportunities. This position is also accountable for the technology transfer and life cycle management plan for any CMOs that Spark utilizes
Describe the essential daily job functions and include % of time spent on each.
% of Time
Job Function and Description
- Serve as the Technology Transfer Process Team Lead
- Lead interface between Technical Operations and Process Development.
- Lead and manage the authorship of and/or author/own Technology Transfer Procedures, Manufacturing Batch Records, Process SOPs, Process Validation Protocols, Process Characterization Summary Reports, and any process related compliance documents
- Responsible for all aspects of process validation including: Process Characterization, Process Validation and Continued Process Verification
- As requested by Process Development, evaluate and propose changes to process/technology to improve compliance or efficiency. Implement strategies relating to new process improvements and capital investments.
- Write, Review deviations pertaining to manufacturing processes and perform product impact assessments for facility, and raw material deviations.
- Design process characterization protocols as needed, and oversee that Process Monitoring regulatory requirements are being met.
- Lead Root Cause Analysis and Risk Assessment Programs and address gap assessments in preparation for GMP Manufacturing
- Approvals of any Manufacturing Change Controls, Validation protocols, and CAPAs
Manage Manufacturing Science & Technology team to achieve business goals and objectives.
- Manage performance. Ensure every team member knows what is expected of them, what it takes to be successful, and how they are progressing. Provide team members with continuous and on-going performance feedback. Hold everyone accountable to achieve results while demonstrating the Spark Values. Help team members understand how their work contributes to the overall success of Spark by periodically reviewing individual objectives to ensure alignment to corporate and functional objectives, making adjustments if priorities have shifted.
- Develop team members. Help employees effectively assimilate to Spark and continually grow through challenging experiences so they can realize their full potential. Understand your employee’s goals, strengths and motivators. Partner with your employees to identify areas for development, conduct coaching conversations regularly and provide guidance on ways to develop through on the job experiential learning, social networks and development opportunities.
- Foster Spark’s Culture, Mission, Vision, and Values: Lead by example. Create an environment where team members thrive in our Culture by living our truths, always in compliance with applicable laws and regulations. Emphasize to employees that “how” they achieve performance objectives is just as important as “what” they accomplish.
- BS/MS/PhD in Life Science/Engineering or related field required.
- Minimum 15 years of experience in the Biotechnology or Pharmaceutical industry.
- >10 years of direct supervisory experience of technical professionals and managerial level staff with demonstrated effectiveness in providing guidance, mentorship and support to staff.
- Experience in biopharmaceutical based GMP manufacturing science and technology including direct experience in cell culture, recovery and purification
- Proven track record organizing and operating a manufacturing facility
- Demonstrated technical project management experience to develop project goals, deliverables and timelines
- Experience with accelerated CMC development pathways a plus
- Knowledge of GXP compliance
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.