- Help to define the scope of late-stage process development activities such as process characterization and development of scale-down models.
- In concert with CMO, help to define the scope of PPQ activities.
- Support scale-up activities and manufacture of Phase 3 and Commercial scale quantities of the VAX-24 Conjugate Drug Substances.
- In concert with CMO, implement the appropriate equipment required to perform late-stage manufacturing.
- Contribute to CMO Manufacturing oversight via document review, person in plant responsibilities, and troubleshooting when necessary.
- Facilitate cross-functional process risk analysis using appropriate tools such as FMEA, leading to the identification of CPPs and CQAs.
- Present/communicate data to the Conjugation Development team.
Requirements: - PhD in Chemical/Biochemical Engineering or similar, MS with 2+ years of industry experience, or BS with 5+ 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) and practical experience with DoE software.
- Experience with late-stage process development activities such as risk assessments (e.g., FMEA) and identification of CPPs and CQAs is a plus.
- Bioconjugate or protein purification knowledge and experience, including expertise in tangential flow filtration (TFF) 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 and independently to deliver results.
- Strong interpersonal skills, with excellent written and verbal communication skills.
Reports to: Associate Director, Conjugation Development and Clinical Manufacturing
Location: San Carlos, CA
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $129,000 – $146,000
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Engineer II, Conjugation Development - San Carlos, United States - Vaxcyte, Inc.
Description
Join our Mission to Protect HumankindVaxcyte 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, periodontitis 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:
*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.
*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.
*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 an Engineer II with experience in Process Characterization (PC) and Process Validation (PV) Stage 1&2 to join the Conjugation process team. The candidate will execute PC strategy for the Conjugation portion of the manufacturing process that will enable a timely and successful PPQ campaign. The candidate will also be responsible for CMO oversight.
Essential Functions:
