- Develop and execute upon a high-level plan for validating the upstream commercial manufacturing process for the polysaccharide components of Vax-24.
- Work with Process Development SMEs within the group and at CMO to complete risk assessments for critical process parameter identification.
- Design process characterization studies to assess the criticality of parameters and manage a team to execute these studies.
- Lead the authoring of PC reports and review PPQ protocols along with CMO counterparts.
- Collaborate with CMOs to develop a validation plan for at-scale validation of the polysaccharide manufacturing process and drive the execution of that plan.
- Work with internal stakeholders (e.g., Regulatory) to ensure that the Polysaccharide Upstream validation strategy fits within the program-wide strategy.
- Collaborate with project management to maintain a detailed timeline for the activities that must be completed prior to a commercial PPQ campaign – communicate to team when activities are at risk of causing delays to timeline.
- Lead the development of the upstream processes for pipeline vaccine-based polysaccharides (transferred from the Research team).
- Mature early-stage polysaccharide fermentation processes to be commercially ready.
- Manage a group of scientists and engineers that develop upstream processes from early stage to late stage within a world class upstream laboratory.
- Collaborate effectively with the downstream groups within polysaccharide development and manufacturing team.
- Be an outstanding teammate and collaborate across groups both internal and external to Vaxcyte.
- Represent upstream development at CMC meetings and with external partners.
- Cultivate a cohesive, innovative, nimble and productive team environment.
Requirements: - PhD in Chemical/Biochemical Engineering or similar, with 7+ years of industry experience; MS with 10+ years of industry experience; or BS with 15+ years of industry experience.
- In depth experience with upstream process characterization work. i.e. risk assessments, identification of pCPPs, PC reports etc.
- Strong understanding of design and interpretation of multi-variate development experiments (e.g. Design of Experiments) with practical experience using software required for these experiments.
- Excellent judgment when assessing risk – strong understanding of when to expend resources to reduce risk and when the level of risk is acceptable to move forward.
- Excellent background in fermentation development demonstrated through years of industrial experience.
- Experience working with BSL2 organisms, Streptococcus pneumoniae and Escherichia coli a plus.
- Strong ability to motivate, mentor, and connect with junior team members.
- Strong sense of organization, preferably with experience managing timelines using a tool such as Microsoft Project.
- Ability to work across several teams to pull required information from SMEs and integrate it into centralized plan.
- Curiosity and drive to quickly come up to speed; creativity to solve challenging problems.
- Strong interpersonal skills, with excellent written and verbal communication skills.
- All Vaxcyte employees require vaccination against COVID-19.
Reports to: Senior Director, Polysaccharide Process Development & Manufacturing
Location: San Carlos, CA
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $211,000 – $225,000
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Director, Upstream Polysaccharide Process 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 a Director/Associate Director with significant experience in early-stage fermentation development and late-stage Process Characterization (PC) to join the Polysaccharide process team. The candidate will take a leading role in designing upstream PC studies that will enable a timely and successful PPQ campaign. In addition, this person will organize, oversee and drive the upstream early phase pipeline programs. This is a critical role for the polysaccharide team which will require someone who is creative, flexible and can adapt in a fast-paced environment.
Essential Functions:
