Senior Engineer, Conjugation Development

Vaxcyte; San Carlos (CA); On-site; USD 170,000 - 198,000; Full time

Job summary

Vaxcyte is seeking a Sr. Engineer in Conjugation Development to lead TFF and filtration operations, transfer conjugation processes to CMOs, and generate regulatory-supportive documentation.

Requirements include PhD/MS/BS with extensive GMP experience, DoE knowledge, and strong cross-functional collaboration skills; onsite in San Carlos, CA with multi-project responsibility.

Qualifications

• PhD/MS/BS with hands-on experience scaling processes from development to manufacturing.
• Hands-on GMP manufacturing knowledge or experience.
• Experience transferring processes to CMOs and overseeing development/manufacturing at CMOs.

Responsibilities

• Lead pre-commercial CDMO TFF and filtration operations across conjugation network.
• Oversee document authoring, review, and person-in-plant activities at CMOs.
• Develop data analytics platforms to trend GMP and process performance.
• Support scale-up activities and tech transfer of early phase candidates to CMOs.
• Facilitate cross-functional risk analyses (FMEA) and identify CPPs/CQAs.
• Present data to Conjugation Development and broader CMC teams.
• Collate data and author supplementary docs for regulatory filings (BLA/CPV).
• Mentor junior team members.

Skills

GMP experience

TFF

Dead-end filtration

Scale-up

DoE

Cross-functional teamwork

Technical communication

Education

PhD in Chemical/Biochemical Eng

MS in relevant field

BS with 10+ years experience

Tools

DoE

CMO transfer

Job description

Join our Mission to Protect Humankind!

Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.

WHAT we do is every bit as important as HOW we do it! Our work together is guided by four enduring core values:

• *RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.
• *AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.
• *LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.
• *MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.

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:

Salary Range: $170,000 - $198,000 (SF Bay Area). Salary ranges for non-California locations may vary.

Equal Opportunity

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.