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

Vector BioMed jobs

Vector BioMed | Quality Control Assay Development Scientist | gaithersburg, md