Research Associate, Vaccine Stabilization

Location
Rockville, MD
Salary
$43=47k based on degree and experience
Posted
Apr 02, 2021
Required Education
Bachelors Degree
Position Type
Full time

Sanaria is an innovative biotechnology company working on a novel malaria vaccine.

Position: 

In this position you will be involved in research and product manufacture as part of the Vaccine Stabilization and Logistics (VS&L) team. The principal areas of responsibility are the cryopreservation of malaria sporozoites (SPZ) for research and for the cGMP manufacture of SPZ clinical products, maintenance of SPZ product inventory, and support of the vaccine vialing operation. Additionally, you will be involved shipping products in liquid nitrogen vapor phase (LNVP) to clinical sites and for research, in foam drying for stabilization of the Salmonella Ty21a-based products and with cryopreservation of mosquito eggs.

Sanaria’s departments are organized as a matrix and personnel also work with other teams as needed: principal areas of responsibility in other departments may include verification of mosquito rearing and gametocyte culture operations, radiation-attenuation of SPZ, SPZ extraction by micro-dissection of mosquito salivary glands and Quality Control assays.

Sanaria’s main mission is the development of a highly protective vaccine against malaria caused by Plasmodium falciparum (Pf), the species responsible for most deaths from malaria. PfSPZ Vaccine, which will soon enter phase 3 clinical trials, comprises whole, aseptic, attenuated, purified, and cryopreserved Pf SPZ. Plasmodium spp are eukaryotes and therefore must be stabilized by cryopreservation, a process involving controlled cooling to below -150 °C and storage in LNVP cryobanks. PfSPZ Vaccine is shipped using LNVP cryogenic dry shippers to clinical trial sites where the cryovials of vaccine are thawed and prepared for inoculation.

Specific Responsibilities:

Duties and responsibilities include the following:

Vaccine Stabilization: Cryopreservation and Foam Drying

  • Cryopreserve PfSPZ (including in vitro produced PfSPZ) for research and cGMP production
  • Cryopreserve other species of Plasmodium: P. yoelii, P. knowlesi, P. vivax
  • Participate in cryopreservation studies with the eggs of Anopheles mosquitoes
  • Perform endpoint assays on Pf, Py, Pk, and Pv SPZ for release, stability timepoints, and research
  • Run foam drying experiments and perform residual water analyses

PfSPZ product manufacture

  • Work in Sanaria’s clean room Clinical Manufacturing Facility
  • Provide support to the vaccine fill-finish operations
  • Follow cGMP and Aseptic Technique procedures
  • Support the attenuation of PfSPZ, dosimetry
  •   Storage and Retrieval Participate in storage of cryovials in LNVP cryobanks for all teams Assist in maintenance of inventory of cryopreserved stocks for research and cGMP
  • Retrieve cryovials for all groups for research, cGMP assays and clinical trials
  • Train personnel on thawing cryopreserved products and dilution of PfSPZ products
  •   Logistics: Shipping
  • Assist with the logistics of shipping to clinical trial sites
  • Ship materials using LNVP cryoshippers, dry ice, and ambient shipping cartons, thermometers and temperature data loggers
  • Assist in training of teams from clinical trial sites in LNVP storage and maintenance of vaccine
  • Assist in shipments of Pf-infected mosquitoes to trial sites and to other researchers

Viability Assay

  • Perform the sporozoite membrane integrity assay (SMIA) for research and cGMP
  • Train personnel on thawing, dilution of PfSPZ products and SMIA

Record Keeping and Presentation

  • Assist in the creation of SOPs and Batch Records for cGMP processes
  • Generate and maintain equipment logs
  • Track and record equipment and supplies usage
  • Follow Good Documentation Practice and Good Distribution Practice
  • Organize and collate clinical trials logistics documentation in coordination with Pharmaceutical Operations
  • Maintain Lab Notebook(s) for experiments (manual written entries)
  • Management of data using Excel and Microsoft Word
  • Knowledge and Abilities:
  • To perform the responsibilities of this job successfully, an individual must be able to perform each essential duty satisfactorily at a minimum. Requirements are representative of the necessary knowledge, skills and abilities. Under the Americans with Disabilities Act, (ADA), reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education, Work Experience

  • BS or MS in biology, biotechnology, bio/engineering, or related discipline
  • Experience working in a biotechnology environment
  • Experience in operating specialized laboratory and pilot scale manufacturing equipment
  • Possess good analytical skills
  • Knowledge of Good Laboratory Practice and application in lab duties
  • Good inter-personal skills and communication (written and oral)
  • Proficient at writing and at oral presentations
  • Proficient in the use of a standard desktop computer and software programs including MS Office
  • Ability in computer-aided design software, such as Solidworks, a bonus
  • Effective project and time management skills
  • Good team player

Sanaria is an equal opportunity employer that has a diverse workforce. Applicants must have long-term authorization to work in the US without visa sponsorship. We offer a competitive benefits packing including health, dental, vision, 401k with employer match, company paid life, short-term and long-term disability.