- Leading formulation activities related to process scale up (e.g. filter investigation and mixing system development
- Leading 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 >7 years of industrial experience; or PhD in Pharmaceutics, Chemistry, Biophysics or Biochemistry with >5 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 optimisation 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
- Managerial experience is of notable benefit
- 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 navigates Vaxcyte's 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
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Senior Scientist, Formulation Development - San Mateo, United States - Vaxcyte Inc
Description
Job Description
Job DescriptionCompany Profile:Vaxcyte, Inc. (Nasdaq: PCVX) is a next-generation vaccine company seeking to improve global health by developing superior and novel vaccines designed to prevent some of the most common and deadly infectious diseases worldwide. Our exclusively licensed cell-free protein synthesis platform and our proprietary know how enable us to design and produce optimized protein carriers and antigens, the critical building blocks of vaccines, in ways that we believe conventional vaccine technologies cannot. Our pipeline includes pneumococcal conjugate vaccine, or PCV, candidates that we believe are the most broad-spectrum PCV candidates currently in development, targeting the $7 billion global pneumococcal vaccine market. Our lead vaccine candidate, VAX-24, is a preclinical, 24-valent broad-spectrum pneumococcal conjugate PCV with preclinical proof-of-concept demonstrating potential to replace the standard of care that we expect to advance into clinical trials in the second half of 2021. Our pipeline also includes VAX-XP, a PCV with an expanded breadth of coverage of at least 30 strains, including newly emerging strains responsible for invasive pneumococcal disease and antibiotic resistance; VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; and VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease by targeting the keystone pathogen responsible for this chronic, oral inflammatory disease. We completed our initial public offering in June 2020, raising $287.5 million in gross proceeds.
Summary:Vaxcyte 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 partly lab based, which will require excellent scientific judgement, independence, rigor and thorough record keeping. It will also require management of junior scientists.
The primary responsibility for the incumbent will be to co-ordinate formulation development activities of Vaxcyte's lead product candidate post Ph1/2, through Phase 3 and culminating in BLA filing and commercial manufactures.
Essential Functions:
Requirements:
