Scientist, Analytical Development, Molecular Assays (Gene Therapy)

Randstad USA

Pennington, NJ

JOB DETAILS
HEADQUARTERS
Pennington, NJ, US
LOCATION
Pennington, NJ
POSTED
6 days ago
job summary:

This role actively contributes to, and provides scientific Subject Matter Expertise (SME) for, assays (qPCR, ddPCR, cell-based, immunoassay) in support of the gene therapy analytical development group. This involves collaborating with scientific leadership within the analytical development organization to help establish, and routinely run, the characterization assays necessary to support the discovery, formulation development, process development and manufacturing of gene therapy products..

 
location: Pennington, New Jersey
job type: Contract
salary: $50 - 55 per hour
work hours: 9 to 5
education: Masters
 
responsibilities:
  • Actively contributes to the development and execution of the product characterization analyses (qPCR, cell-based assay, immunoassay) required to support method development activities associated with the process development and manufacturing of gene therapy products.
  • Contributes to the scientific advancement of activities conducted in-house or by Contract Research Organizations (CROs)/Contract Manufacturing Organizations (CMOs).
  • Provides technical expertise within the analytical development team to review and trend analytical data for product characterization.
  • May contribute to authoring and/or reviewing method development reports, SOPs, validation protocols/reports, comparability protocols and reports, justification of specifications, and other relevant sections of regulatory filings. These include, but may not be limited to, INDs, IMPDs and BLAs.
  • Assists in advancing scientific and regulatory capabilities by maintaining and actively advancing his/her knowledge regarding relevant topics. S/he may also participate in industry trade groups and conferences.
  • May oversee or mentor junior scientists. This includes providing scientific and technical support to help troubleshoot and solve scientific challenges.
  • Builds the scientific knowledge, capabilities, and strategies in gene therapy product characterization that enable fast to clinic/fast to market product development and commercialization.
  • Actively contributes to, and assures the development of, science-driven, phase appropriate, and risk-based analytical development strategies to support development projects from candidate nomination to clinical development and commercial manufacture.
  • Performs other tasks and assignments as needed and specified by management.
 
qualifications:
  • PhD in molecular biology, virology, biochemistry or related field OR a Master's degree in these same disciplines and a minimum of 5 years of relevant and progressively responsible experience in biologics and/or gene therapy analytical roles.
  • Hands-on/applied experience with the development of analytical assays for virus products.
  • Demonstrated understanding of other analytical methods used for gene therapy characterization.
  • Experience in CMC analytical and regulatory requirements are preferred - including the determination of product specifications and extended analytical characterization.
  • Excellent verbal and written communication skills.
  • Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
  • Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
  • Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects at various stages of development.

Preferred:

  • Experience in interacting with CROs/CMOs.
  • Small company and/or start-up experience.
 
skills: Molecular Biology, Assay Development

For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

About the Company

Randstad USA

Randstad was founded in 1960 by Frits Goldschmeding. We've never let go of his passion or the values that he established. By staying true to those fundamentals, we've expanded to represent more than 90 percent of the HR services market.

We provide outsourcing, staffing, consulting and workforce solutions within the areas of engineering, accounting and finance, healthcare, human resources, IT, legal, life sciences, manufacturing and logistics, office and administration and sales and marketing. We can’t wait to tell you all about it.

Our mission is to be a world leader in matching demand for, and supply of, labor and HR services. We believe in the value of work as a unifying force that shapes society for the better. We live by the core values established early in our company's history: to know, serve and trust, striving for perfection and simultaneous promotion of all interests.

COMPANY SIZE
10,000 employees or more
INDUSTRY
Staffing/Employment Agencies
FOUNDED
1960
WEBSITE
https://www.randstadusa.com/