Senior Associate Scientist- Cell Based Assay, Analytical Development

Solid Biosciences Cambridge , MA 02138

Posted 3 months ago

Summary:

The Senior Associate Scientist-Bioassay will demonstrate strong knowledge in cell-based potency assays, ELISA and other techniques such as Octet, qPCR, ddPCR. Strong problem-solving and troubleshooting skills along with proficiency in analyzing data, laboratory documentation, data presentation and collaboration are also desired. Responsible for analytical development, qualification and operational support for Preclinical, Phase 1 and Phase 3 of clinical products for Solid Biosciences. Solid Biosciences' leading candidate is an adeno-associates virus (AAV) based gene therapy product for the treatment of Duchenne Muscular Dystrophy (DMD).

Key Duties & Accountabilities:

  • Execute experiments in support of Bioassay and Cell-based Assay method development and optimization, with guidance from internal management

  • Participate in Bioassay and Cell-based method qualification/validation and method transfer studies

  • Provide support to QC investigations through experimental design, data mining and analysis, problem solving and technical writing

  • Lab operation: routine and non-routine analytical testing, coordination with internal/external PD or cGMP Manufacturing, maintain laboratory equipment, maintain laboratory inventory, compile and present data to support process development and stability

  • Optimize, qualify, monitor performance and maintain inventory of assay specific Reference Standard and Critical Reagents used in Quality Control Bioassays and Cell Culture

  • Create technical protocols and reports for Critical Reagents and Reference Standards.

  • Trend and report method and Critical Reagents performance data

  • Maintain well documented records of analytical data, laboratory notebooks, execution of assays and stability data

  • Performs other related duties and ad hoc projects as required by position

Competencies Required:

  • Experience in development and optimization of bioassays and cell-based assays

  • Working knowledge of molecular-based (PCR) assays and virology preferred

  • Excellent communication, technical and organizational skills are required

  • Must be a team player prepared to work in, and embrace a team-based culture

  • Proven troubleshooting, technical writing, problem solving and investigational skills

Knowledge:
Education, Experience, &

Skills:
  • Bachelor's degree or equivalent and relevant formal academic/vocational qualification with at least 6 years of relevant experience, or Master's degree with 4+ years' experience

  • Experience in cell-based potency assays, ELISA, and other techniques such as Octet, qPCR, ddPCR

  • Problem solving and troubleshooting skills, along with proficiency in data analysis, and lab documentation

  • Understanding of compliance and cGMP considerations

Travel Commitment:

  • Some travel may be required
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Senior Associate Scientist- Cell Based Assay, Analytical Development

Solid Biosciences