GenScript

CMC Analytical Scientist

GenScript • $80K — $110K *
Pennington, NJ 08534In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
1 week ago
Job Overview by Ladders

Qualifications

  • Ph.D. with 2+ years or M.S. with 3+ years in a relevant field.
  • Proven experience in lentiviral vector release testing and characterization.
  • In-depth knowledge of molecular and cell biology techniques like qPCR and ELISA.
  • Hands-on expertise in Western blotting and flow cytometry.
  • Exposure to NGS methods for vector characterization is advantageous.
  • Understanding of Good Documentation Practices and data integrity principles.
  • Strong problem-solving abilities and team collaboration skills.

Responsibilities

  • Support the development and maintenance of a GMP QC-Analytics Lab.
  • Generate and characterize engineered cell lines for assay development.
  • Develop and execute molecular assays to evaluate vector performance.
  • Independently perform and analyze experiments, presenting data clearly.
  • Prepare technical reports and presentations for decision-making support.
  • Collaborate with teams to assist in technology transfer and CMC activities.
  • Drive continuous improvement by implementing new tools and best practices.

Benefits

  • Opportunity to lead and evolve the function within a CDMO business.
  • Work on projects that positively impact patient lives.
  • Collaborative work environment across cross-functional teams.
  • Continuous improvement culture focused on innovation in analytics.
Full Job Description
Position Overview:

The position reports to the Sr. Scientist, is ideally suited for a professional with extensive technical knowledge, and a proven track record of developing and carrying out processes, that are suitable for use in GMP manufacturing of a wide range of clinical trial materials, and participating in the technology transfer. There is a great opportunity to lead and evolve this function within a CDMO business, to support a broad portfolio and advance the manufacturing capabilities to deliver products to the client projects that transform the lives of patients.

Responsibilities:
  • Support the set-up, development and maintenance of a GMP QC-Analytics Lab
  • Generate and characterize engineered cell lines, including production of MCB and WCB for cell-based assay development.
  • Develop, optimize, and execute molecular and cellular assays to assess vector performance using qPCR/ddPCR based assay, Western blot, ELISA and Flow cytometry.
  • Independently plan, perform, analyze, and interpret experiments, present clear data summaries and recommendations to cross-functional teams and clients.
  • Prepare technical reports, study summaries, and presentation materials to support decision-making.
  • Collaborate closely with other teams in CMC and coordinate cross-functional activities to support tech transfer and CMC activities.
  • Drive continuous improvement by identifying and implementing new tools, technologies, and best practices in CGT CMC analytics.
  • Ensure compliance with BSL-2 biosafety standards, cGMP, and applicable regulatory requirements.

Qualifications:
  • Ph.D. with 2+ years or M.S. with 3+ years in Molecular Biology, Cell & Gene Therapy, Biochemistry, or related field.
  • Demonstrated hands-on experience in lentiviral vector release testing and characterization (required).
  • Expertise in molecular and cell biology techniques, including qPCR, ddPCR, ELISA or DNA Sequencing/Analysis.
  • Hands-on experience with Western blotting and flow cytometry for protein and cell-based analyses.
  • Exposure to NGS-based methods for vector or genome characterization is a plus.
  • Working knowledge of Good Documentation Practices, data integrity, and ALCOA+ principles.
  • Strong problem-solving skills with the ability to work independently and collaboratively in a team environment.
  • Excellent interpersonal, verbal, and written communication skills.
  • Familiarity with regulatory requirements and guidance from agencies such as FDA and ICH; experience with EU Annex 1 and laboratory audits is a plus.


Pay range is estimated between $80k - $110k based on skill set and experience.

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About GenScript

GenScript Biotech Corporation is a global biotechnology group headquartered in Piscataway, New Jersey, United States. The company provides biological research services and products to scientists in pharmaceutical, biotechnology, agricultural, and academic settings. The company's services include gene synthesis, peptide synthesis, protein expression, antibody development, and in vitro and in vivo pharmacology studies. The company's products include molecular biology reagents, peptides, proteins, antibodies, and cell line development services. The company has subsidiaries in the United States, Europe, Japan, and China. GenScript was founded in 2002 by Frank Zhang and has grown to become a leading provider of gene synthesis services and other biotechnology products and services.
Learn more about GenScript
Size
3,000 employees
Industry
Pharmaceuticals & Biotech
Founded
2002
* Ladders Estimates

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