Manager/Senior Manager, AAV Upstream Process Development

Manager/Senior Manager, AAV Upstream Process Development
Editas Medicine, United States

Experience
1 Year
Salary
0 - 0
Job Type
Job Shift
Job Category
Traveling
No
Career Level
Telecommute
No
Qualification
Master's Degree
Total Vacancies
1 Job
Posted on
Mar 5, 2021
Last Date
Apr 5, 2021
Location(s)

Job Description

Key Responsibilities amp; Accountabilities:

This role on the Process and Analytical Development (PAD) team contributes to Editas efforts to develop safe and effective gene therapies using CRISPR-based gene editing technologies.

  • Act as the subject matter expert on AAV upstream process development
  • Collaborate with contract development and manufacturing organization (CDMO) to support upstream activities during process development, preclinical, clinical and potentially commercial manufacturing
  • Responsible for the technical aspect of cell banking for both host cell and plasmid
  • Design bioreactor, shake flask, iCellis, cell culture vessel studies at CDMO for AAV upstream process development, characterization and performance qualification and define upstream process control strategies, comparability studies (if needed)
  • Lead upstream activity support for technology transfers, scale up and scale down, manufacturing operations and deviations / investigations by designing and executing appropriate studies at CDMO
  • Independently design and manage the execution of experiments (DOE) to generate optimal and robust upstream processes at CDMO
  • Utilize upstream process derived data (e.g. bioreactors, BGA, metabolite analyzers) and literature research to monitor process performance, support deviation reports and technical investigations and aide in process optimization/development
  • Assess impact and facilitate closure of deviations, ensure appropriate scoping of change controls and CAPAs, and develop risk assessments related to upstream processes
  • Author and review technical protocols and reports, CMC regulatory sections, process summaries, study design and protocols, SOPs, etc
  • Establish routine upstream process data trending activities
  • Ensure accurate and complete documentation of any scientific experimental plan, data and report
  • Build and maintain good working relationships with internal and external stakeholders e.g. Research, Development, Quality, suppliers, contract manufacturing organizations etc
  • Independently analyze data, present results and conclusions to the team
  • Improve the understanding, robustness, and economics of commercial manufacturing processes
  • Establish and maintain familiarity with contemporary industrial standards, practices, technologies, literature and ways of performing lab studies

Requirements

Knowledge, Skills amp; Capabilities:

  • Good understanding of scaling up and scaling down considerations for upstream processes
  • In depth understanding and hand on experience in one or more of the following area is required: cell banking, plasmid, bioreactor, iCellis, CellStack, HyperStack, process modeling
  • Demonstrated upstream subject matter expertise and hands-on upstream laboratory experience
  • Good understanding of biopharma operations, GxPs, ICH guidelines, process characterization, and technology transfer
  • Proven project management skills
  • Strong communication skills
  • Excellent analytical thinking and problem-solving skills
  • Knowledge of statistical methods for DOE design and data analysis (e.g. JMP), experience with Quality by Design (QbD) is preferred
  • Strong technical writing skills
  • Ability to manage multiple tasks and meet deadlines with a high tolerance for ambiguity
  • Ability to manage multiple programs in matrix environment
  • Ability to lead problem solving for issues related to upstream process development, qualification and validation
  • Ability to prioritize project work and make effective use of available resource to meet agreed timelines
  • Ability to author and approve comprehensive and accurate protocols/reports
  • Ability to select, implement and use appropriate data management concepts and tools
  • Ability to function independently and communicate cross functionally across various teams
  • Ability to manage priorities, and engage/communicate in a multidisciplinary environment

Education amp; Relevant Work Experience:

  • MSc degree (PhD preferred) in a relevant scientific discipline e.g. Bioengineering, Biology, Biochemistry, Virology, with 8-10+ (MSc) or 4-6+ (PhD) years of relevant experience
  • Experience in upstream process development and bioreactor operation with viral vectors (2-3+ years) or biologics (4+ years)

Physical amp; Travel Requirements:

  • Travel to vendors and CDMOs, as needed (lt;10%)

Job Specification

Job Rewards and Benefits

Editas Medicine

Information Technology and Services - Cambridge, United States
© Copyright 2004-2024 Mustakbil.com All Right Reserved.