PhD in Chemical/Biochemical Engineering or similar with 2+ years of industry experience; MS with 5+ years; or BS with 10+ years.
Practical and theoretical knowledge of engineering principles for scaling processes.
Working knowledge of GMP manufacturing requirements, with hands-on experience preferred.
Experience with CMOs and ability to oversee development and manufacturing activities.
Solid understanding of Design of Experiments (DoE) principles.
Experience with late-stage process development activities and risk assessments is a plus.
Expertise in tangential flow filtration (TFF) and dead end filtration.
Responsibilities
Lead pre-commercial CDMO TFF and filtration operations across the conjugation network.
Contribute to CMO manufacturing preparation and oversight through document authoring and troubleshooting.
Develop data analytics platforms for GMP and commercial process performance.
Support scale-up activities and tech transfer of clinical candidates to external CMOs.
Facilitate cross-functional process risk analysis using tools like FMEA.
Present data to the Conjugation Development team and broader CMC team.
Author supplementary documents for regulatory interactions.
Benefits
Comprehensive benefits package.
Equity component included.
Full Job Description
Summary:
The Development organization is comprised of four Process teams: Protein, Polysaccharide, Conjugate Drug Substance (Conjugation), and Drug Product. These Process Development teams are supported by Analytical Development and Formulation Development teams. Vaxcyte is looking for a Sr. Engineer with experience in campaign support, tech transfer, and GMP/regulatory authoring to join the Conjugation engineering team. The candidate will manage the TFF and dead end filtration operations of our CMO partners, transfer new conjugation processes from the San Carlos labs to a CDMO, and generate documentation supporting our regulatory filings.
Essential Functions:
Lead all pre-commercial CDMO TFF and filtration operations across our conjugation network, and provide technical support to our commercial operation partners
Contribute to CMO manufacturing preparation and oversight via document authoring, document review, person in plant responsibilities, and troubleshooting when necessary
Develop data analytics platforms to trend and summarize GMP and Commercial process performance, enabling both process optimization as well as Continued Process Verification
Support scale-up activities and tech transfer of early phase clinical candidates to an external CMO
Facilitate cross-functional process risk analysis using appropriate tools such as FMEA
Present/communicate data to the Conjugation Development team as well as broader CMC team
Collate data and author supplementary documents for BLA, CPV, and other regulatory interactions
Serve as a guide and mentor to junior team members
Requirements:
PhD in Chemical/Biochemical Engineering or similar, with 2+ years of industry experience; MS with 5+ years of industry experience; or BS with 10+ years of industry experience
Both 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, preferably with hands on GMP experience through either a Manufacturing or MSAT role
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-plant oversight activities
Solid understanding of the principals of DoE (Design of Experiments)
Experience with late-stage process development activities such as risk assessments (e.g., FMEA) and identification of CPPs and CQAs is a plus
Experience writing IND, BLA, or CPV sections is a plus
General regulatory experience is a plus
Expertise in tangential flow filtration (TFF) and dead end filtrations
Bioconjugate or protein purification knowledge and experience, process scaling and optimization, and reactor scale up is a plus
Demonstrated success working in a cross-functional team environment on multiple projects; ability 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: Associate Director, Conjugation Development
Location: San Carlos, CA
Work Arrangement (may be adjusted based on business needs, job responsibilities, or changes to company policy): Onsite (minimum of 4 days per week onsite)
Compensation: The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $170,000 - $198,000 (SF Bay Area). Salary ranges for non-California locations may vary.
About Vaxcyte
Vaxcyte is a clinical-stage biotechnology company developing a new generation of vaccines to address some of the most important and deadly infectious diseases worldwide. The company's cell-free protein synthesis platform, comprising the XpressCFTM platform, is capable of rapidly generating protein antigens that can be used in vaccines to protect against bacterial and viral pathogens. Vaxcyte's lead vaccine candidate, VAX-24, is a preclinical, 24-valent pneumococcal conjugate vaccine (PCV) being developed for the prevention of pneumococcal disease. The company is also developing VAX-XP, a PCV with expanded serotype coverage, as well as vaccines for Group A Streptococcus, Group B Streptococcus, and Lyme disease.
