GenScript

Scientist, Analytical Development

GenScript • $90K — $120K *
Pennington, NJ 08534In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
1 month ago
Job Overview by Ladders

Qualifications

  • Master's degree with 2+ years of relevant experience, Bachelor's with 5+ years, or Ph.D. with relevant experience.
  • Degree in Chemistry, Biochemistry, Molecular Biology, or related field; gene and cell therapy experience is a plus.
  • Hands-on experience with UPLC/HPLC, CE-SDS, and/or AUC; familiarity with MALS and CAD detectors is advantageous.
  • Experience executing assays under SOPs in a regulated environment.
  • Strong problem-solving skills for independent and collaborative work in a fast-paced setting.
  • Familiarity with Good Documentation Practices, Data Integrity, and ALCOA+.
  • Strong interpersonal, verbal, and written communication skills.

Responsibilities

  • Apply bioprocessing knowledge to aid in method development and troubleshooting.
  • Establish and optimize Analytical Development and Quality Control labs for GMP and Non-GMP testing.
  • Design and execute analytical methods including method development and product testing.
  • Own the lifecycle management of analytical methods, including documentation and protocol review.
  • Support procedure lifecycle activities by authoring and reviewing SOPs and forms.
  • Perform and interpret various analytical assays such as UPLC/HPLC and AUC.
  • Identify and drive continuous improvement initiatives in assay development and quality control.
  • Analyze data sets and communicate findings and recommendations to stakeholders.
  • Collaborate cross-functionally with development and manufacturing teams for product advancement.
  • Perform additional duties as assigned, involving up to 15% travel for projects.

Benefits

  • Opportunity to lead and evolve the analytical function within a dynamic CDMO environment.
  • Engagement with a broad portfolio of clinical trial materials potentially impacting patient lives.
  • Chance to collaborate cross-functionally, enhancing professional networks and skill sets.
  • Continuous improvement culture that supports innovation and efficiency in processes.
Full Job Description
Position Overview:

The position reports to the Sr. QC Manager 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:
  • Apply knowledge of bio separation techniques to support method development, troubleshooting, and process characterization
  • Support the establishment, development and optimization of Analytical Development (AD) and Quality Control (QC) laboratories to enable both Non-GMP and GMP testing•
  • Design, develop, and execute analytical methods, including method development, method qualification/validation, technology transfer, and product testing.
  • Own method lifecycle management activities, including authoring and reviewing protocols, reports, and technical documentation.
  • Support procedure lifecycle activities, including authoring and reviewing Standard Operating Procedures (SOPs) and associated forms. Perform
  • and interpret a broad range of analytical assays, including but not limited to UPLC/HPLC, CE-SDS, and analytical ultracentrifugation (AUC).
  • Drive continuous improvement initiatives across AD and QC, identifying opportunities to enhance assay robustness, efficiency, and data quality.
  • Analyze complex datasets and effectively communicate results, observations, and recommendations to internal and external stakeholders
  • Collaborate cross-functionally with Process Development, Manufacturing, and Quality teams to support product and process advancement.
  • Perform other duties as assigned based on business needs
  • Up to 15% traveling to support CDMO projects or business development activities.

Qualifications:
  • Master's degree with 2+ years of relevant industry experience, or Bachelor's degree with 5+ years, or Ph.D. with relevant experience.
  • Degree in Chemistry, Biochemistry, Molecular Biology, or related scientific field; experience in gene and cell therapy is a plus.
  • Hands-on experience with analytical techniques such as UPLC/HPLC, CE-SDS and/or AUC; experience working with MALS and/or CAD detectors is a plus.
  • Experience executing assays in accordance with Standard Operating Procedures and protocols in a regulated or controlled environment.
  • Strong problem-solving skills with the ability to work independently and collaboratively in a fast-paced environment.
  • Familiar with principles of Good Documentation Practices, Data Integrity, and ALCOA+.
  • Strong interpersonal, verbal, and written communication skills.
  • Experience with Next-Generation Sequencing (NGS) is a plus.
  • Experience with Microsoft Office tools. Experience with statistics, coding, programming, troubleshooting, and/or data management software is a plus.

Pay range is estimated between $90k - $120k based on skill set and experience.

# LW

# PB

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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