Principal/Sr Scientist, Plasmid/Nucleic Acids, Process Development
Overview
Overview

CBM

Full Time EE - Onsite

Center for Breakthrough Medicines is on track to be the largest single-site cell and gene therapy contract development and manufacturing organization in the world. Our comprehensive service offering accelerates speed to market through supply chain disruption mitigation strategies, end-to-end program management expertise and unique platform technology with the ability to follow a molecule from idea to commercialization. CBM’s integrated approach provides high quality and consistent end-to-end manufacturing capability including: Process and Analytical Development; Plasmid DNA production; Viral Vector Production of Lentivirus; AAV and Adenovirus; Testing and Analytics; Autologous, Allogeneic and Gene-edited Cell Therapy Bioprocessing; and Cell banking. CBM’s horizontal and vertical integration provides one source throughout a product’s life cycle.

CBM’s mission is to accelerate the delivery and affordability of lifesaving and life-changing therapies from discovery to market by offering a complete solution for the development and commercialization of cell and gene therapies.

CBM is located just outside of Philadelphia in the Heart of Cellicon Valley on The Discovery Labs campus set on 300 acres with 2.4 million square feet of life sciences lab and manufacturing space, allowing clients to scale their development and manufacturing needs without ever having to change sites, while providing employees a true community campus experience focused exclusively on life sciences.

Summary

This role is responsible for planning, performing, analyzing, summarizing, reporting, and presenting experimental results related microbial fermentation and purification process development. The ideal candidate will help design and startup a nucleic acid process development laboratory to support plasmid DNA production and mRNA synthesis. The scientist will develop a platform microbial fermentation process and subsequent downstream purification at both the laboratory and pilot scale. Experience in Microbial Fermentation Upstream and/or Purification Process development and optimization is a requirement. This position works closely with internal and external stakeholders to deliver technical documents such as reports, protocol, and data reviews. 

The primary responsibility of this candidate is to develop a scalable end to end plasmid production platform. The scientist will also collaborate with both external and internal stakeholders to support ancillary activities such as analytical testing, cell banking, process scaleup, and technical transfer.  In addition to the technical skills required (plasmid process development, scale-up, and production), this role authors and reviews technical protocols and reports, drafts batch records and SOPs.  The ideal candidate will successfully demonstrate upstream and downstream process development, scaleup, and analytics. Personal attributes including independent thinking, having a self-starter mindset, and strong collaboration skills are required. The final level of this position will be set according to candidate experience and qualifications.

Responsibilities

  • Designs and implements microbial strategies for upstream and downstream process development
  • Hands-on work in the developing, executing, and optimizing of upstream (fermentation, scale-up, characterization) and downstream (centrifugation, chromatography, and tangential flow filtration) unit operations for plasmid production
  • Support technology transfer into GMP manufacturing
  • Works closely with external partners on appropriate process and characterization studies to enable manufacturing
  • Authors and reviews development and process protocols, reports, and batch records
  • Supports analytical method development, qualification, transfer, and associated protocols/reports as needed
  • Assists with product quality attribute assessment and scoring to identify critical quality attributes (CQA)
  • Supports fermentation upstream and/or downstream process development activities
  • Traditional hours are expected, but will require occasional night, holiday, or weekend work in accordance with laboratory schedule
  • Potential responsibility to lead a small team


Qualifications

  • PhD in chemical engineering, microbiology, biochemistry, biotechnology, biology, or related field with 4+ years of industry-related experience; or M.S. with 6+ years; or BS with 8+ years of related industry experience
  • Ability to lead a cross-functional team to deliver on programs. Management experience is a plus but required
  • Experience in plasmid and novel nucleic acid processes and technologies
  • Experience in molecular biology, plasmid design and elements, and manufacturing processes, specifically, transformation, cell banking, production, purification, and storage
  • Knowledge and experience in fermentation, purification, and analytics
  • Proficient with large-scale (50L) fermentation and purification processes
  • Ability to design experiments, follow procedures with attention to detail, and successfully execute experiments at the bench
  • Project-management skills and ability to work successfully with contracting laboratories and manufacturing facilities
  • Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities
  • Demonstrated ability to maintain detailed execution records and perform data analysis
  • Knowledge or experience with viral vector manufacturing in the biotech industry
  • Expertise in microbial upstream and downstream process development, such as large-scale (50L) fermentation, depth filtration, tangential flow filtration, chromatography column purification
  • Experience with Design of Experiment (DOE)
  • Experience with microbial production, purification, and characterization
  • Strong communication skills (e.g., clear and concise) and a team player
  • Strong time and project management skills
  • Strong critical and logical thinking with ability to analyze problems, identify alternative solutions, and implement recommendations for resolution
  • Self-motivated and flexible, able to prioritize, multi-task, and work in a fast-paced & demanding environment
  • Takes ownership of the assigned project, consulting with management and peers
  • Able to understand and interpret data/information and its practical application


Special Incentives

TBD