Director, Manufacturing
Vor 3 Tagen
**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**:
As Vaxcyte’s products progress towards late stage and commercialization, Vaxcyte is initiating development of dedicated biologics manufacturing facilities. This position will lead all aspects of manufacturing activities related to Process Validation, commercial Launch, and routine GMP Manufacturing to ensure the efficient and compliant production of Vaxcyte's products.
Working closely with Process Development, MSAT, Supply Chain, Quality, Project Management, Business Development and Regulatory functions as well as with CDMOs; this position will oversee all hands-on operations of Vaxcyte’s GMP manufacturing locations and support the implementation of the global manufacturing network strategy. This role will be responsible for timely, compliant, secure, and uninterrupted supply of Vaxcyte’s innovative therapies. It is necessary to possess solid knowledge of GxP (GMP, GLP, GCP) regulations as well as expertise in running GMP facilities. Cross-functional teamwork and working with CDMOs is paramount in this role. This position will report to the Executive Director, Operations of Vaxcyte Switzerland.
**Essential Functions**:
- Oversee commercial production, implementation and execution to ensure that production schedules are met, and products are manufactured according to current Good Manufacturing Practice guidelines.
- Directs and leads a team of manufacturing managers to accomplish the goals of the manufacturing department, consistent and with established manufacturing and safety procedures.
- Collaborates closely with Senior Management, Functional/Department Heads, and project team members.
- Coordinates resource planning across programs to ensure adequate resources are available, escalate and resolve issues.
- Supports CDMO in setting up and maintaining operational capabilities to maximize reliability of production.
- Builds confidence and then maintains relationships with the involved CDMOs
- Fosters an environment of performance, efficiency, compliance, continuous improvement, and exceptional quality standards at the CDMOs.
- Regularly ensures manufacturing operations are running efficiently and that all level of manufacturing personnel at CDMO are appropriately trained and qualified to perform work assigned.
- Implement and monitor key performance indicators, highlighting progress, risks, and mitigation options.
- Ensure that manufacturing equipment is properly maintained, calibrated, and qualified to guarantee consistent and reliable operation.
- Works closely with Quality Control and Supply Chain to ensure that raw materials, intermediate products, and finished pharmaceutical products meet quality standards and specifications.
- Closely tracks planned and scheduled manufacturing activities at CDMOs to optimize resource utilization and meet production targets while minimizing downtime and waste.
- Ensures together with Supply Chain the timely availability of raw materials, packaging components, and other resources required for manufacturing operations.
- Makes sure that accurate and up-to-date records of manufacturing processes, quality control testing, and regulatory compliance activities are available.
- Ensures compliance with regulatory requirements, including GMP, safety and environmental regulations, and other relevant guidelines.
- Supports validation and qualification activities for equipment, processes, and facilities to ensure compliance with regulatory requirements and industry standards.
- Reviews batch production records to ensure completeness, accuracy, and compliance with established procedures and specifications.
- Manages technical input to batch records and other quality documents according
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