- Responsible for helping to develop robust, scalable, and cost-effective upstream (cell-free) procedures for the GMP manufacture of early and late stage clinical trial material
- Assist in technology transfer activities for processes developed at Vaxcyte to external CMOs for GMP production
- Require 80-90% time in the lab
- Interface closely with the Research group, write detailed technical reports, make presentations to the development team, and author internal publications
- BS in Biochemical or Chemical Engineering with 3+ years of industry experience; MS with 1+ years of industry experience
- In-depth practical experience with microbial fermentation
- Theoretical knowledge of cell free systems; practical experience a plus
- Ability to optimize expression of proteins, especially difficult to make non-antibody proteins
- Understanding of engineering principles involved in scaling processes from development lab to pilot / manufacturing plant
- Working knowledge of the requirements of GMP manufacturing; hands-on GMP experience a plus
- Experience working with CMOs; ability to effectively transfer processes to CMO, and assist in overseeing development and manufacturing activities performed at CMO; ability to travel to CMO (some international travel required) to perform person-in-plant oversight activities
- Solid understanding of the principals of DoE (Design of Experiments); practical experience with DoE software; proficient in the design and interpretation of statistically-modelled experiments
- Experience with depth and membrane filtration; experience with tangential flow filtration a plus
- Demonstrated success working in a cross-functional team environment; ability to work effectively as a member of a team to deliver impactful results
- Strong interpersonal skills, with excellent written and verbal communication skills
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Gilead Sciences, Inc. Foster City, United StatesFor Current Gilead Employees and Contractors: · Please log onto your Internal Career Site to apply for this job. · At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - workin ...
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Associate Scientist I, Upstream Process 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 purposing the Xpress CF technology to produce best-in-class conjugate vaccines and novel antigen-based vaccines. For the production of best-in-class conjugate vaccines, Vaxcyte is conjugating antigenic polysaccharides to specific sites on a proprietary nnAA-containing polypeptide uniquely produced via the platform. The open cell-free system also permits manipulation of multiple parameters (pH, temperature, redox potential etc) that govern protein folding. High fidelity control of these conditions unlocks a cache of "tough to make proteins" by permitting the optimal folding of complex antigens into their most immunogenic conformation leading to the production of novel complex antigen-based vaccines.
Vaxcyte is looking for an energetic and talented individual to assist in the Upstream Process function within the Protein Process Development group. The successful candidate would partner with the other members of the PD team, collectively providing rigorous scientific leadership.
Essential Functions:
Requirements:
Location: Foster City, CA
Compensation: The compensation package will be competitive and includes comprehensive benefits and an equity component.
