Process Sciences Leader

Philadelphia, Pennsylvania
Salary not provided
November 24 2021
Organization Type
For the products assigned to the Process Sciences Leader:

  • Serve as the Technology Transfer Process Team Lead
  • Be the lead interface between , Process Development, Analytical Sciences, QA/QC, Materials Management and Facilities & Engineering.
  • 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
  • In collaboration with Process Development, evaluate and propose changes to process/technology to improve compliance or efficiency. Implement strategies relating to new process improvements and capital investments.
For the products assigned to the Process Sciences Leader:

  • Responsible for all aspects of process validation including: Process Characterization, Process Validation and Continued Process Verification
  • Design characterization protocols as needed, and oversee that Process Monitoring regulatory requirements are being met.
For the products assigned to the Process Sciences Leader:

  • Write, Review deviations pertaining to manufacturing processes, facility, and raw materials
  • Lead Root Cause Analysis and Risk Assessment Programs and address gap assessments in preparation for GMP Manufacturing
  • Lead any Manufacturing Change Controls, Validation protocols, and CAPAs

Education and Experience Requirements

  • PhD in Life Science/Engineering or related field required with a minimum of 5-8 years of related experience
  • May also have a Bachelor’s Degree or Master’s degree with 8+ years of related experience
  • Experience in biopharmaceutical based GMP manufacturing science and technology including direct experience in cell culture, recovery and purification
  • Demonstrated technical project management experience to develop project goals, deliverables and timelines
  • Experience with accelerated CMC development pathways a plus
  • Knowledge of GXP compliance
Key Skills, Abilities, and Competencies

  • The position requires extensive knowledge and experience with cGMP upstream and downstream 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 matrix technical teams to achieve objectives. Acts to promote a productive and cooperative climate. Helps to promote team effectiveness by engaging in a trusting, supportive partnership with others. Respectfully holds self and team members accountable to goals and metrics. Facilitates a beneficial resolution of competing objectives and technical differences, transparently and in a timely manner. Resolve conflicts in a constructive manner that allows win/win solution, when possible and in effective tradeoff decision cycles when necessary.
  • 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.
  • Experience with SAS JMP, Microsoft Project, process mapping and Lean management tools a plus.
  • Should have high organization and situational awareness and be skilled in the craft of communication in all forms, to all levels of the organization.
Complexity and Problem Solving

  • Demonstrated ability to manage an appropriate level of risk in technical and project management realms.
  • Able to lead technical teams in the development and evaluation of new technology, and subsequently prepare business plans to enable life cycle development.
  • 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.
Internal and External Contacts

Accountable to Technical Operations

Internal Contacts – Manufacturing Operations, QC, QA, Facilities, Process and Analytical Development

External Contacts – Raw Material Vendors, CMO/CDMO relationships, and Partnerships.

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.

Nearest Major Market: Philadelphia

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.

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