Quality Control Assay Development Scientist

1 month ago

gaithersburg, United States Vector BioMed Full time

JOB DESCRIPTION

QC Assay Development Scientist

 

General Overview:

Vector BioMed is a state-of-the-art contract development and manufacturing organization (CDMO) specializing in best-in-class lentiviral vectors. We are looking for a highly motivated and experienced Scientist to join our growing team. Responsibilities include Developing, Qualifying, and Validating Analytical Methods commonly used for-in-process, stability, and release testing of GMP manufactured viral vectors in a QC setting. The ideal candidate will have a strong background in assay development and qualification of methods used to characterize GMP manufactured biologics.

 

Responsibilities:

  • Responsible for assay development/qualification/validation and generation of reports. Methods may include cell-based assays, molecular assays (PCR), Immunoassays, Flow cytometry, etc.
  • Responsible for method transfer from internal and external clients.
  • Work collaboratively within a team to achieve QC objectives for timely testing of manufactured products and contribute to, or lead, troubleshooting activities.
  • Draft, Review, and Follow written procedures and adhere to good documentation practices.
  • Participate as a team member on cross functional teams and be given project assignments to train, develop problem solving, and increase technical expertise.
  • Proactively identify and implement changes to business and QC processes that improve efficiency and robustness.
  • Adhere to quality standards for job training and ensure GMP compliance.

 

Qualifications:

  • Advanced degree (Master’s or Ph.D.) in relevant scientific discipline with a minimum of 4 years experience with Assay Development/Qualification and method transfer supporting cGMP operations in biotech / life sciences (Position title commensurate with experience).
  • Experience with mammalian cell culture, aseptic technique, Molecular Biology (digital PCR, sequencing, etc.), Flow Cytometry, Immunoassays; Bioinformatics experience is a plus
  • Experience writing and performing method qualification/validation protocols, data analysis, performing method transfer, and writing method qualification/validation reports; experience in cell and gene therapy is a plus.
  • Direct experience in the following activities related to Analytical Method Qualification and/or Validation:

o  Designing studies

o  Drafting and Executing protocols

o  Analyzing results to define assay performance characteristics based on regulatory guidance and fit-for-purpose best-practices

o  Writing reports

  • Excellent communication, interpersonal, and leadership skills, with the ability to collaborate effectively with cross-functional teams and stakeholders at all levels.
  • Proven ability to problem-solve, prioritize tasks, and make decisions in a fast-paced and dynamic environment.
  • Experience working in GMP environment beneficial.
  • Proficiency in statistical data analysis software (e.g., JMP, GraphPad, Minitab, etc.) and Microsoft Office Suite (Word, Excel, PowerPoint, etc.).

 

Benefits:

  • A competitive salary and potential for annual bonus
  • Opportunities for learning and growth
  • Company-paid holidays and paid time off
  • Health, dental, and vision care
  • 401K plan
  • Short-Term and Long-Term Disability benefits
  • Life insurance
  • On-site gym

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