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Scientist, AAV Analytical Development - Contract-to-Hire

  • Location Cambridge
  • Job type Contract
  • Reference BBBH111028

COMPANY:

Leading genome editing company

LOCATION:

Cambridge, MA

TITLE:

Scientist, AAV Analytical Development - Contract-to-Hire

RELOCATION ASSISTANCE:

Not available.

ROLE RESPONSIBILITIES:

This individual will serve as the SME for AAV Analytical Development to support potency, impurity, identify testing of drug substance and drug product. This person will collaborate with CMOs and CTLs to support analytical activities during process development preclinical, clinical and potentially commercial manufacturing. Other responsibilities include:

  • Design studies for AAV analytical development, characterization, qualification, validation to support release testing, stability study, and extended characterization
  • Develop reference standard material qualification strategy
  • Lead analytical activity support for technology transfers, assay deviations / investigations by designing and executing appropriate studies at CMO
  • Independently design and execute experiments (DOE) to generate optimal and robust analytical assays
  • Assess impact and facilitate closure of deviations, ensure appropriate scoping of change controls and CAPAs, and develop risk assessments related to analytical assays
  • Author and review technical protocols and reports, CMC regulatory sections, assay summaries, study design and protocols, SOPs, etc
  • Establish routine analytical data trending activities

CANDIDATE REQUIREMENTS:

  • MS or PhD degree in a relevant field.
  • In depth understanding and hand on experience in one or more of the following area is required: real time PCR (vg titer, residual DNA) or digital droplet PCR, immunoassays (ELISA or MSD for capsid titer and residual protein), plaque assay, TCID50 (infectious titer), separation methods (SDS-PAGE, CE, SEC, IEX, HIC, RP, FFF, affinity chromatography), mass spectromeotry (qToF for peptide mapping, intact mass analysis, protein modification), light scattering methods (MALS, DLS), bioburden, endotoxin, virus screen, electron microscopy, analytical ultracentrifugation etc
  • Fundamental understanding of assay development, qualification, validation and transfer
  • Good understanding of biopharma operations, GxPs, ICH guidelines, process characterization/validation 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

If you meet the requirements above and would like to be considered for this position, apply on-line now for immediate consideration and to be contacted with further details.