Scientist II, Formulation Development

 Our client is looking for an energetic and talented individual to join our Formulation and Drug Product Development team. The candidate will have extensive knowledge and practical experience in formulation development of vaccines, preferably adjuvant containing formulations, complemented with a broad range of vaccines analytical techniques and in particularly in-depth experience in biophysical characterization of formulations. The candidate will have a strong industry based experience in bringing a product from early to late-stage development, including process scale-up and manufacturing. Having worked with external analytical and manufacturing CMOs would be beneficial as well as a good understanding of GxP testing and manufacturing guidelines.   This position is for a scientific role which will be mostly lab based, which will require excellent scientific judgement, independence, rigor and thorough record keeping.   The primary responsibility for the incumbent will be to facilitate formulation development activities of company’s lead product candidate post Ph1/2, through Phase 3 and culminating in BLA filing and commercial manufactures.

Essential Functions:

• • Progressing formulation activities related to process scale up (e.g. filter investigation and mixing system development.
  • Progressing formulation development activities, including stability studies for thermal, freeze/thaw, and agitation as well as container closure system evaluation for both Drug Substance (DS) and Drug Product (DP) materials.
  • Work with external analytical and manufacturing CMOs to enable tech transfer and implementation of processes and analytical methods.
  • Apply biophysical characterization techniques to fully understand antigen/adjuvant interactions and to assess formulation matrix optimization options.

• • BSc or MSc in Pharmaceutics, Chemistry, Biophysics or Biochemistry preferred, with >4 years of industrial experience; or PhD in Pharmaceutics, Chemistry, Biophysics or Biochemistry with >2 years of relevant experience.
  • Experience of manufacturing within GxP environments either directly or through CMOs.
  • The candidate will have had extensive experience in developing proteins, polysaccharides and/or protein conjugates formulations for vaccines, preferably vaccine systems containing adjuvants (other biological experience also considered).
  • Experience leading stability studies is required and the use of DoE for complex system optimization would be beneficial.
  • Experience in spectrometric methodologies, HPLC/UV, particle light scattering analysis, quantitative subvisible particle analysis, visible analysis, is needed.
  • Strong scientific leadership is required: critical thinking, ability to present complex data sets and to independently propose and design follow-up experiments.
  • The candidate should have high degrees of both flexibility and organizational skills as well as an eagerness and ability to learn in order to effectively navigate multiple projects and timelines.
  • Strong interpersonal skills; ability to communicate effectively both verbally and in written formats (must be able to work with managerial and lab team in remote setting when needed) are necessary to collaborate effectively with the rest of the Formulation and Drug Product Development team and well as across other teams.
  • Detail oriented, rigorous and excellent skills in record keeping/documentation.
  • All employees require vaccination against COVID-19.