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Manufacturing Science & Technology Upstream Senior Scientist

Date: Aug 4, 2019

Location: Philadelphia, PA, US

Company: Spark Therapeutics

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 Senior Scientist will be responsible for identification and 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

 

Responsibilities

55% 

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.

 

Responsibilities (Cont'd)

30% 

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. 

15%

Manage individual performance to achieve business goals and objectives, as well ongoing professional development.

  • 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.

Qualifications

  • The position requires extensive 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. 
  • 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 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.
  • 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. 

Requirements

  • BS/MS/PhD in Life Science/Engineering or related field required. 
  • Minimum 6 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


Nearest Major Market: Philadelphia