Sr Scientist Formulation

Gaithersburg, MD 20879

Posted: 07/03/2019 Industry: Biotech/R&D/Science Job Number: 49210

Assay validation/qualification, protein assay experience, assay development.

Conduct pre-formulation and formulation studies for liquid and lyophilized vaccines adsorbed to aluminum based adjuvants. Coordinate preparation, storage and testing of pre-clinical samples for multiple projects simultaneously. Maintain electronic and physical inventory of pre-clinical and stability samples prepared by FD and coordinate sample submissions to the analytical department (AD) for physicochemical testing or to the Potency Assay Unit (PAU) group for pre-clinical studies in animals. Perform stability and characterization studies for R&D and clinical vaccine samples.

Responsibilites
  • Develop appropriate assays to characterize the content and the purity of the biological and adjuvant molecules in the liquid and dry presentation
  • Identify formulations matrices that ensure the stability of targeted biological and the adjuvant molecules at the desired storage conditions
  • Determine primary degradation pathways for biological and adjuvant molecules, including proteins adsorbed to alum and other adjuvants
  • Utilize appropriate analytical techniques for optimization of formulation and process parameters for liquid or dry vaccine presentation
  • Provide support to formulate small and large scale lots of liquid, frozen or lyophilized vaccine samples
  • Provide support to formulate small and large scale lots of liquid, frozen or lyophilized vaccine samples
  • Run tests and assays such as % moisture content, particle size distribution analysis, SDS-PAGE, Western Blot, ELISA, Bradford and BCA
  • Help maintain laboratory equipment up-to-date for maintenance and calibration schedules

Technical Skills required:

Knowledge of the following techniques or formulation methods are preferred:
  • Hands-on experience in the use of freeze-drying equipment, lyo cycle design and problem solving related to lyophilization process
  • Some knowledge in protein and immunological assays such as ELISA, SDS-PAGE, Western Blot, Southern Blot, protein staining, Bradford, cell based toxin neutralizing assays
  • Hands-on experience in dry formulation assays such as the Karl Fischer residual moisture content analysis and Differential Scanning Calorimetry
  • Understanding of biophysical techniques such as Dynamic light scattering, UV-visible and fluorescent spectroscopy
  • Hands-on and problem solving in analytical methods and equipment


Additional Responsibilities Include:

Support lead formulation selection by designing and conducting pre-formulation studies to analyze stability, solubility, effects of pH and temperature, and compatibility of vaccine components.
Develop and characterize parenteral formulations for preclinical and early clinical studies in dry and liquid presentations
Design and conduct stability studies at various stages of formulation development
Transfer formulation processes and analytical methods across groups
Support testing of new drug formulations at various stages of development
Optimize formulations and characterization assays for late-stage clinical trials.
Documentation
Ensuring that laboratory notebooks are used to adequately and accurately document technical work and are reviewed and signed for content and intellectual property
Writing internal reports, technical documentation and other appropriate documents as required
Work within internal and external quality systems to ensure documentation trails are maintained throughout
Writing and reviewing of appropriate technical SOPs for use both internally and at CMO and/or CROs
Communication
To communicate ideas and strategies with colleagues and the Process & Analytical Development Director
To work closely with colleagues and/or mentors for acquiring direction and reporting progress on assigned projects
To report progress on a regular basis to the appropriate Process & Analytical Development Director
To monitor and communicate progress, and highlight delays or potential risks to project timelines
Present technical data and information to the function as appropriate
The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.

Education, Experience & Skills
Masters or PHD

Self-motivated, the candidate will have the ability to work with tight deadlines and adapt to changing priorities in a fast paced environment
Some experience in performance of analytical assays to support formulation development for parenteral administration in both pre-clinical and clinical studies
Ability and understanding in the selection of appropriate stability indicating techniques for evaluation of formulations for adjuvants and proteins
Some understanding and hands-on experience in running stability programs
assay development

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