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Manufacturing Science and Technology Upstream Research Scientist

Date: Aug 5, 2019

Location: Philadelphia, PA, US

Company: Spark Therapeutics

Summary

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.

 

SUMMARY

The Manufacturing Science and Technology (MS&T) Upstream Research Scientist will be responsible for development of cell culture technologies as a basis for manufacturing platform development.  Through a combination of in-house capabilities and by leveraging external resources, the MS&T Operations group will support ongoing manufacturing and product Lifecyle projects for both drug substance (DS) and drug product (DP) specific activities include:

  • Process scale up, support and trouble shooting
  • process characterization
  • process and method validation studies
  • small scale model qualification
  • control strategy development
  • investigation support to close deviations (non-conformance)
  • technology development and technology transfer driven by product lifecycle requirements
  • raw material qualification and characterization
  • technology platform development and integration

 

Summary Continued

The MS&T Upstream Research Scientist will be responsible for authoring and reviewing relevant sections of regulatory dossiers as well as answering any upstream related 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 execution of process and material characterization, process data management/intelligence and process validation.

  • During the manufacturing preparation phase, this role will lead delivery of 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.  To meet these deliverables the MS&T lab will both generate data and compile data from external sources, e.g. CDMOs, CMOs.
  • During the manufacturing execution phase, lead selected 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, complete investigations, auxiliary studies and data analysis to ensure timely product disposition.  In addition, contribute to playbooks in anticipation of regular Agency and Partner interactions. 
  • Throughout all phases, this position will execute Root Cause Analysis, as well as drive continuous improvement and process improvement opportunities. This position will contribute to development of life cycle management plans in cross functional forums.  Regular interactions, including oversight roles, for any CMOs that Spark utilizes will be ongoing.
Responsibilities

Core Team member of Technology Transfer & Process Teams in the role of Upstream Technical subject matter expert (SME).

  • Directly execute and manage studies in support of ongoing manufacturing and technology development.
  • Continuously monitor and evaluate upstream technologies related to efficient, robust and scalable adhesion and suspension cell culture technologies, including media development.  
  • 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 execution of process lifecycle studies 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.
  • Manufacturing Support

  • 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, collaborate with Manufacturing on CAPA effectiveness.
  • As needed, be present at CMOs & CDMOs to monitor execution of production and studies, as well provide technical guidance as needed. 
Requirements
  • BS/MS/PhD in Life Science/Engineering or related field required. 
  • Minimum 3 years of experience in the Biotechnology or Pharmaceutical industry.
  • Experience in biopharmaceutical based GMP manufacturing science and technology; direct experience in cell culture in development and production environments. 
  • Proven track record of contributions to upstream 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
Competencies
  • 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.
  • Develops stretch goals and uses effective motivation techniques to achieve them.  Strong team diagnostic skill and strategy for team growth.  Shapes site goals and policies. 
  • Able to effectively lead cross functional teams.
  • Ability to motivate staff, foster a culture of continuous improvement and operational excellence
  • LEAN leadership experience beneficial. 
  • Experience with data analytic tools such as SAS JMP a plus. 


Nearest Major Market: Philadelphia