Senior Scientist, Protein Process Development

Location
Foster City, CA, United States
Posted
Jan 01, 2021
Ref
1588996112
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time
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, candidate s 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 wi th 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:

The Development organization is comprised of four Process teams: Protein, Polysaccharide, Conjugate Drug Substance, and Drug Product. These Process Development teams are supported by Analytical Development and Formulation Development teams. Vaxcyte is look ing for a S enior Scientist to join the Protein Process Development team and take the lead in developing the downstream purification processes for multiple protein antigens that are part of VAX - A1 vaccine .

Essential Functions:

• Take the lead in developing downstream purification process for multiple protein antigens that comprise the VAX - A1 vaccine, an early stage clinical candidate; purification process must be robust, scalable , and cost - effective
• Spend ~5 0- 80% time in the lab
• M anage at least one direct report
• Collaborate with Analytical Development to develop and implement assays to assess product quality, including product concentration assays utilizing MSD technology
• Participate in cross -functional project teams and provide regular progress updates
• Lead technology trans fer activities for the process developed at Vaxcyte to an external CMO for GMP production

Requirements:

• PhD in Chemical Engineering , Biochemistry, or a related discipline, with 2 + year s of industry experience ; MS with 5 + years of industry experience ; or BS with 1 0 + years of industry experience
• In depth protein purification knowledge and experience, including familiarity with AKTA lab - scale and preparative chromatography systems and Unicorn software
• B oth practical experience with and theoretical knowledge 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 highly desired; ability to effectively transfer processes to CMO, and to oversee development and manufacturing activities performed at CMO; ability to travel to CMO (some international travel required) to perform person - in -plan t oversight activities
• Extensive h ands- on experience purifying untagged protein s from crude lysate to high purity
• 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, nominal , and tangential flow filtration
• Ability and desire to learn upstream cell -free production system used to express proteins
• Proficiency running gel - and column - based analytical methods a plus; such methods may include SDS - PAGE, Western blotting , IEF, SEC, HIC, IEX , RP, Mass Spec, and binding affinity or activity assays (such as MSD or ELISA)
• Experience writing IND section(s) a plus
• Demonstrated success working in a cross -f unctional team environment on multiple projects ; a bility to work both on a team (as member and/or leader) and independently to deliver results
• Strong interpersonal skills, with excellent written and verbal communication skills

Reports to: Director, Protein Process Development and Manufacturing

Location: Foster City, CA

Compensation:

The compensation package will be competitive and includes comprehensive benefits and an equity component.