Principal Scientist- HPLC
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Principal Scientist- HPLC

King of Prussia, PA

The 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.

The Discovery Labs is a Global Platform Company inclusive of CBM, The Discovery Labs Properties, UniteIQ incubator labs, and The Colony, a unique investment and resource model enabling groundbreaking therapies to be brought to life.

Summary

Center for Breakthrough Medicines is seeking a Principal Scientist responsible for the implementation, development, and validation of analytical test methods in support of process research, discovery research, cGMP production, and stability testing, with particular emphasis on HPLC. The primary responsibility of this role will be to lead and supervise a team of scientists applying HPLC testing to support production and process development teams. Major support functions include sample analysis by HPLC. Other duties may involve analytical method modification, development, and validation. The candidate will prepare and review technical documents, including validation protocols/ reports and test procedures. The Principal Scientist will function as the primary contact on multiple chemical development projects; therefore, in-depth involvement with the project team concerning the chemistry of the project and analytical chemistry needs is expected. You will be expected to manage a dynamic team and lead/spearhead scientific excellence within a large group.

Responsibilities

  • Operate and maintain/repair complex laboratory Waters and Agilent UPLC, UPLC/MS, LC/MS and SFC/MS instruments including routine troubleshooting in safe working environment
  • Supervise, direct, and review the work of other analytical chemists and scientists
  • Provides training on analytical chemistry and cGMP procedures; Manages performance for the direct reports
  • Analyze research and production samples
  • Prepares SOPs, test methods, and other GMP documentation
  • Reviews data generated by other analysts
  • Independently, detects and solves complex problems of high technical difficulty
  • Applies knowledge and expertise from multi-disciplines (including QA, QC, Analytical and production) to achieve project goals
  • Conducts investigations independently
  • Independently perform all technical assignments, and troubleshoot analytical instrumentation
  • Qualifies reference standards
  • Develops new analytical procedures
  • Validates analytical methods
  • Prepares and reviews scientific reports
  • Interfaces with internal and external clients

Qualifications

  • PhD in analytical chemistry or a related discipline with at least 5 years of post-graduate, industrial or academic experience
  • 2 years of GMP experience in a regulated lab a plus
  • Demonstrated proficiency of multiple applicable techniques such as: HPLC (IEX, SEC, RP) cIEF and CGE
  • Experience operating and maintaining/repairing complex laboratory Waters and Agilent UPLC, UPLC/MS, LC/MS and SFC/MS instruments including routine troubleshooting in safe working environment
  • Extensive experience with analytical HPLC is preferred with deep knowledge of gene therapy products with structure elucidation experience in viral capsid proteins for AAV and Lentiviral products
  • Knowledge and experience performing experiments in accordance with cGMP regulations, established processes and protocols, and applicable SOPs
  • Proven ability to interpret data by performing trend analysis
  • Ability to independently optimize analytical methods
  • Proven problem solving and troubleshooting abilities
  • Ability to work in a collaborative work environment with a team

Compensation: TBD

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