layiq
worthy; deserving; fitting; suitable.
A role, opportunity, or path that merits attention, time, and pursuit.
Loading LAYIQ…Job opportunity
Vaxcyte
San Carlos, California, United States
Source: Vaxcyte careers · View original posting
From Vaxcyte's posting. “We” and “our” refer to the employer.
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.
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.
The Director for Drug Substance (DS) Commercialization of Conjugation will lead and facilitate launch readiness and commercial supply of glycoconjugate drug substances, including the polysaccharide activation, conjugation, and associated raw materials. This role focuses on technical launch planning and execution by bringing best-practices and coordinating cross-functional efforts for regulatory filings, facility readiness, and launch supplies.
This role also provides leadership to ensure that the organization is equipped to effectively communicate the scientific and commercial rationale for critical raw material manufacturing processes to internal stakeholders, relevant CMOs, and to regulatory agencies. The incumbent will work with the organization to ensure on-time execution and appropriate planning for commercial lifecycle management.
Manufacturing Science and Technology (MSAT) is responsible for successfully and seamlessly transitioning the vaccine process from Process Development to Commercial, developing and executing technical launch and commercialization strategy, continuously improving process robustness through to end of lifecycle, and ensuring best possible patient outcomes while creating value for the enterprise.
As part of the Commercial Manufacturing and Supply Chain organization, MSAT will lead the technical and process support for end-to-end commercial manufacturing, including Polysaccharides, Carrier Proteins, and Conjugation across all Drug Substances (DS).
The range of activities will include technology transfer support, process characterization experiments in support of validation, process improvement, evaluation of novel process technologies, investigation of process related manufacturing issues, ensuring continuous improvement in process robustness throughout the product life cycle, etc.
DS Commercialization –
Provide strategic and scientific leadership for polysaccharide activation and conjugation processes with internal and external stakeholders and ensure successful execution of launch plans and post-launch commercial activities.
Organization
– Build a strong and highly-skilled team for the global network with special focus on conjugation manufacturing processes. Support resourcing recommendations on staffing requirements to meet organizational goals.
Process robustness
– Continuously improve process understanding and process robustness using staff and laboratory resources across the organization to monitor, trend, and optimize operations.
Interface
Tech-transfer new technologies
Support technical services
Process validation and comparability
Regulatory
Communicate
Leadership
Travel
Compensation
The compensation package will be competitive and includes comprehensive benefits and an equity component.
$210,000 - $245,000 Remote Salary Range
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.
Recruitment Fraud Notice
Please be aware of fraud or scams from individuals, organizations and/or internet sites claiming to represent Vaxcyte in recruitment activities. Vaxcyte has an established recruitment process for all positions prior to issuing an offer for employment and we will never extend unsolicited employment offers or ask candidates to provide financial or sensitive personal information as part of the application process. All legitimate communication from Vaxcyte will come from an official @vaxcyte.com email address.
Qualified and interested candidates should apply to current openings at vaxcyte.com/careers.
LAYIQ is an independent job-discovery service. This listing does not imply a partnership with or endorsement by the employer. Review the original posting for current details and availability.
Employer posted: