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Genezen

Viral-vector and cell-therapy CDMO provider

Scientist 1 - Analytical Development

Bioprocess & BiomanufacturingConfirmed live in the last 24 hours
Full-timeLexington, MA, USA$85k - $110k /yrIn-person

About the Job

Requirements

  • A Bachelor of Science in a scientific or technical discipline is required.
  • Two to four years of CRO/CDMO experience designing, developing, and executing bioanalytical methods, including method development, qualification, validation, and transfer, is required.
  • Direct hands-on experience with MALS and CAD detectors in AAV analytics is required.
  • Expertise in the biophysical characterization of AAV particles and associated impurities is required.
  • Experience with LC-MS-based assay development is required.
  • Experience documenting and reporting results using electronic laboratory notebooks is required.
  • People training and leadership skills are required.
  • Ability to maintain multiple projects and timelines is required.
  • Excellent verbal and written communication skills are required.
  • High levels of initiative, adaptability, tenacity, and troubleshooting skills are required.
  • Ability to adapt to work schedule changes based on business needs is required.
  • A criminal background check is required.
  • The role requires working frequently in a BSL2 environment with personal protective equipment and aseptic gowning.
  • The role requires frequently standing, sitting, handling objects, reaching, and using close vision; it occasionally requires walking, climbing or balancing, stooping, kneeling, crouching, crawling, and lifting or moving up to 25 pounds.
  • The role requires eligibility to work in the United States; visa sponsorship is unavailable.

Responsibilities

  • Establish methods in the Analytical Development and Quality Control laboratories from the bench.
  • Design and execute experiments for the biophysical characterization of viral vector particles.
  • Develop and validate analytical and Quality Control assays, and specify and select equipment.
  • Transfer analytical methods from the Analytical Development laboratory to the Quality Control laboratory while operating under current Good Manufacturing Practice standards and guidance from department and Quality Control leadership.
  • Collaborate with the team to establish and implement regulatory and laboratory practices, and lead complex experiments.
  • Develop and establish high-performance liquid chromatography methods using charged aerosol detection and multi-angle light scattering detectors to characterize adeno-associated virus vectors.
  • Operate high-performance liquid chromatography equipment and troubleshoot it as required.
  • Use ASTRA software for analysis.
  • Maintain familiarity with flow cytometry, enzyme-linked immunosorbent assays, quantitative polymerase chain reaction, and droplet digital polymerase chain reaction assays in lentiviral, retroviral, and adeno-associated virus platforms.
  • Maintain familiarity with current equipment used in the Analytics laboratory.
  • Help management evaluate new technology and bring new platforms in-house.
  • Qualify and validate analytical methods to support current Good Manufacturing Practice testing.
  • Facilitate the transfer of analytical and bioassays from clients to the Analytical Development laboratory and from that laboratory to Quality Control.
  • Assist with training Analytical Development Associates and other team members, and work with other departments on project planning.
  • Support the establishment of site electronic record-keeping systems such as laboratory information management systems or electronic laboratory notebooks.
  • Work with Process Development, Manufacturing, Quality Assurance, and Quality Control as needed.
  • Advise site and Quality management of actual or potential actions that could adversely affect the business, create quality exposures, or represent opportunities.
  • Provide weekly reports to the department head in one-on-one meetings.
  • Meet physical demands of the role, including frequently lifting or moving up to 10 pounds and occasionally up to 25 pounds.

Desired Qualifications

  • Familiarity with OpenLab software for analysis of high-performance liquid chromatography readouts is desired.

About the Company

Genezen

Viral-vector and cell-therapy CDMO provider

Genezen is a contract development and manufacturing organization (CDMO) focused on gene and cell therapies, specializing in viral vectors and transduced cells. It provides end-to-end, fee-for-service development and cGMP manufacturing, from early development through clinical-grade vector production for trials. The company differentiates itself by offering a global, single-partner solution that covers the entire viral vector and cell-therapy pipeline. Its goal is to help clients advance gene and cell therapy programs by delivering reliable development, manufacturing, and testing support toward clinical trials.

Company size
201-500
Company stage
Growth Equity (Venture Capital)
Total funding
$18.5M
Headquarters
Lexington, MA
Founded
2014

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