The Manufacturing Science and Technology (MS&T) Scientist/Engineer will be primarily responsible for support of commercial manufacture for both upstream and downstream aspects of the process. This role will be expected to independently execute tasks in the following areas for both drug substance (DS) and drug product (DP) specific activities to include:
% of Time
Job Function and Description
- Execute Continuous Process improvements/Optimization of current commercial process. Implementation of Product Life Cycle strategy.
- Author and technically support manufacturing deviations, CAPAs, and change controls.
- Manage effective change management processes for projects.
- Drive the development, implementation, and support of: Visual Controls, Root Cause Analysis, Kanban or Kaizen events, GEMBA walks, mistake-proofing and right-first-time.
- Plan and implement continuous improvements in the GMP manufacturing facility and manufacturing operations, with collaboration from stakeholders and impacted departments including Quality.
- Lead investigations.
- Execution of Process Optimization activities including small scale studies prior to implementation.
- Write and 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
- Support reviews of any Manufacturing Change Controls, Validation protocols, and CAPAs, collaborate with Manufacturing on CAPA effectiveness.
- Manage on-time approval and closure of these quality records.
- Continuous improvement Project execution.
Manage individual performance to achieve business goals and objectives, as well ongoing professional development.
Education and Experience Requirements
- 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 in Life Science/Engineering or related field required.
- Minimum 2 years of experience in the Biotechnology or Pharmaceutical industry.
- Experience in biopharmaceutical based GMP manufacturing science and technology.
- Direct experience in cell culture and/or purification (downstream) in development and/or production environments.
Key Skills, Abilities, and Competencies
- Proven track record of contributions to manufacturing technology platform development, in a GLP/GMP Pilot Plant and/or development lab facility.
- Demonstrated technical project management experience to develop project goals, deliverables, timelines, budget management and ongoing prioritization.
- Experience with accelerated CMC development pathways a plus
- Knowledge of GXP compliance
Complexity and Problem Solving
- The position requires knowledge and experience with cGMP upstream 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 investigations, study execution, and produce high quality technical documentation.
- 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 solution
- 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.
- 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.
- Regular cross functional interactions internally with Process Development, Analytical Sciences, QA, QC, RA CM, PMO Functions.
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.
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