The Manufacturing Science and Technology (MST) group resides in Spark’s Technology Development and Operations organization as an arm of the Manufacturing department. MST’s key responsibilities are to support the development and manufacturing of gene therapies, starting with their transition into clinical manufacturing and continuing through the remainder the product lifecycle. This comprises of, but is not limited to, process fit evaluation, tech transfer, person-in-plant support, investigation of deviations, late-stage process development, data analysis, process validation and annual production reporting, all for both internal and external manufacturing.
The Plasmid Process Engineer/Scientist will support production of bacterial plasmids utilized in AAV gene therapy manufacturing. The scope of support will include all activities following plasmid design. Key responsibilities include:
- develop plasmid specifications for early phase AAV candidates by interfacing with R&D
- forecast plasmid supply needs across multiple programs
- evaluate facility fit for plasmid manufacturing
- review CDMO development reports
- lead change management activities for the manufacturing of new plasmid constructs and their implementation into AAV manufacturing
- assess risk associated with plasmid manufacturing process changes and be accountable for the associated change management in the QMS
- investigate process deviations and out-of-specification testing results to establish root cause and corrective actions
- lead knowledge management efforts for plasmid manufacturing
- establish databases for process and testing data and utilize for trending
- contribute to regulatory filings
- review and approve master batch records
- approve release specifications
- review executed batch records
Manage individual performance to achieve business goals and objectives, as well ongoing professional development.
Education and Experience
- Manage performance: Know what is expected, what it takes to be successful, and self-monitor progress. Be accountable to achieve results while demonstrating the Spark Values. Periodically review individual objectives to ensure alignment to corporate and functional objectives, making adjustments if priorities have shifted.
- Commit to collaborate. Be a strong team player and business partner cross functionally. Understand the development goals, strengths and motivators of your colleagues and partner to achieve mutual success and continuous improvement as well as professional development.
- 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 2 years of experience in the Biotechnology or Pharmaceutical industry, which can include any internship / Co-Op experience.
- Experience in developing or supporting processes for plasmid manufacturing
- Proven track record of contributions to manufacturing support or technology platform development, in a GLP/GMP Facility/Pilot Plan and/or development lab facility
- Demonstrated technical project management experience to develop project goals, deliverables, timelines and ongoing prioritization.
Key Skills, Abilities, and Competencies
- Hands-on experience with plasmid expression and/or purification, either in a lab or manufacturing
- Experience with accelerated CMC development pathways
- Knowledge of GXP compliance
Complexity and Problem Solving
- The position requires knowledge of plasmid manufacturing in bacterial systems. Additionally experience with mammalian cell culture manufacturing is a plus.
- Demonstrated ability to lead investigations, study execution, and produce high quality technical documentation.
- Advanced knowledge management, process and cost modeling experience a plus.
- Proven ability to productively collaborate cross functionally to deliver results. Acts to promote a productive and cooperative climate. Helps to promote team effectiveness by engaging in a trusting, supportive partnership with others. Encourages or facilitates a beneficial resolution of purpose. Resolve conflicts in a constructive manner that allows win/win solutions.
- 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.
- Ability to contribute to a culture of continuous improvement and operational excellence
- LEAN leadership experience beneficial.
- Experience with data analytic tools such as SAS JMP a plus.
Internal and External Contacts
- Efficiently complete true root cause analysis, corrective action plan development and execution, including effectiveness verification.
- 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 Operations
- Internal Contacts – Manufacturing Operations, QC, QA, Facilities, Process and Analytical Development
- External Contacts – Raw Material Vendors, CDMO relationships (e.g. Pfizer, other Spark CDMOs)
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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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.