Sr. Manager @ Vaxcyte | Simplify Jobs

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, 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:

This senior level position will provide process validation leadership for vaccine drug substance manufacturing processes. The position leads and/or participates in the planning, preparation, execution, and summarization of process validation activities in the Protein Sciences Department as part of the company’s overall process validation program. The role also provides input into validation assessments supporting investigations, change controls, and periodic reviews associated with the process validation lifecycle for a manufacturing process/product. The incumbent should be able to execute work independently, work with various groups across the organization, coach junior level staff members and/or contractors, be a self-starter, and be able to oversee, lead projects and teams.

Essential Functions:

Leading process validation activities: defining PV strategies in a process validation master plan.
Generating protocols, evaluating data, and writing final reports (PPQ, filter qualification, media/buffer mixing, column or membrane cycling, hold time, etc).
Process validation sampling oversight or coordination.
Generating of regulatory submission document subsections.
Project management of overall and individual PV projects and activities.
Authoring validation impact assessments for investigations.
Authoring justifications for the assessment of change controls for process impact.
Ability to manage multiple projects and activities of moderate complexity simultaneously.
Liaise with functions such as Development, Manufacturing, Supply Chain, Project Management, QA, QC, and Regulatory Affairs as well as off-site functions such as external partners.
Support regulatory inspections through the preparation, defense, and interaction with auditors in areas related to process validation.
The position requires execution and management of multiple projects at the same time and good communication skills to keep customers, peers, area management and senior leadership up to date with progress of all projects in order to ensure validations are completed in a timely manner and on schedule.

Requirements:

Applicants must have a Bachelor’s degree with at least five years of experience; OR a Master’s degree with more than three years of experience; OR a Ph.D. with 0-2 years of experience.
Excellent written and verbal communication skills (high level of English language proficiency).
Previous process validation experience within the pharmaceutical industry and strong knowledge of FDA and ICH guidelines.
High proficiency in Word, Excel and have demonstrated aptitude for computerized systems.
High proficiency in validation technical writing.
Ability to independently manage different projects, deadlines.
Previous tech transfer experience.
Experience with defending validation packages to boards of health/regulators.
Background in problem solving, negotiations, data integrity principles and project management/support in a matrixed reporting environment.
Prior experience in other areas of validation (including equipment validation).
Good understanding of risk management methodologies (e.g. FMEA), with a proven ability to apply to Bio-pharmaceutical operations.

Reports to: Director, Protein 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: $180,000 – $187,000

Send resumes to:

[email protected]

Vaxcyte, Inc.

825 Industrial Road, Suite 300

San Carlos, CA 94070

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.

Sr. Manager

Process Validation MSAT Protein Sciences

Vaxcyte

Compensation Overview

Essential Functions:

Requirements:

6 month growth

1 year growth

2 year growth

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