Sr. Director, Global Drug Product Commercialization Lead
1 month ago
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:
The Drug Product (DP) Commercialization lead develops and facilities DP manufacturing (formulation, fill/finish and container closure) and DP analytical (tech transfer and lifecycle) strategy, program prioritization, and execution to drive the successful launch of products. This role also provides leadership to ensure that the teams are equipped to effectively communicate the scientific and commercial rationale for DP processes/analytical characterization to the manufacturing and quality organization and to the Boards of Health for regulatory submissions for commercialization. This role focuses on technical launch planning and execution by bringing best-practices and coordinating cross-functional efforts to ensure necessary steps are started at the appropriate times and resourced optimally. Works in alignment with network organization to ensure on-time execution and appropriate planning for commercial lifecycle management.
Reporting into the Vice President of Global MSAT, the Senior Director (SD) position will be responsible for providing Process Leadership to MSAT DP functions and relevant DP cross-functional teams across the network. The SD will be a key member of the Global Manufacturing team where they will coordinate and collaborate on overall program strategy, with primary responsibility and accountability for the DP strategy.
Manufacturing Science and Technology (MSAT) is responsible for successfully and seamlessly transitioning the vaccine processes and analytical methods from Process Development to Commercial, developing and executing technical launch and commercialization strategy, continuously improving process robustness through to end of lifecycle, and ensuring Vaxcyte, Inc. Page 2 of 4 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 aspects of analytical and process support for end-to-end commercial manufacturing, including Polysaccharides, Carrier Proteins, Conjugation across all Drug Substances (DS) and Drug Products (DP).
The range of activities will include DP technology transfer support, process characterization experiments in support of validation, process improvement, evaluation of novel process technologies, and investigation of process related manufacturing issues, ensuring continuous improvement in process robustness throughout the product life cycle etc. The MSAT organization will also include analytical sciences and technology (ASAT) for analytical technology transfer support and DS/DP characterization. The ASAT team will support commercial operations as well as the quality chemistry (QC) on all aspects of analytical methodology and heightened characterization studies.
Essential Functions:DP Commercialization - Provide strategic and scientific advice for internal and external stakeholders and ensure successful execution of launch plans and post-launch commercial activities.Organization development - Build a strong and scalable MSAT DP Process organization (including DP ASAT) for the global network with special focus on conjugation science and technologies.Process robustness - Optimize the use of resources (human, and laboratory equipment) across the organization in support of DP lifecycle. Product Characterization - provide analytical support for in-process, release and heightened characterization across the organization in support of the DP lifecycle.Technical agenda - The leader will also be responsible for developing and managing a network-level technical agenda in support of each DP life-cycle planInterface - Manage the technical interface with Process Development, providing technical representation into initial technology transfer, product launch, product lifecycle, to the end of life/product retirement and for defining/developing the next generation of production technologies. Collaboration with cross-functional teams across the network to drive the successful development and commercial launch of pipeline productsStewardship - Ensure stewardship for key modalities (Drug Products), with sufficient process oversight and expertise for each process stepTech-transfer new technologies - Ensure robust processes exist to support technical transfers and integration of new technologiesSupport technical services - Support of our internal and external manufacturing network, including materials management and data analyticsProcess validation and comparability - Provide leadership for the execution of process validation and process comparability activities. Effectively communicate the scientific and commercial rationale for DP processes to the Manufacturing organization for commercializationRegulatory - Engage In technical reviewing and authoring of regulatory filings and responding to questions received from health authorities. Effectively communicate the scientific and commercial rationale for DP processes to the Boards of Health for regulatory submissions for commercializationCommunicate - Effectively and efficiently communicate process performance to key stakeholders (internal-facing and external-facing)DP thought partner - Serve as a thought partner with Regulatory, CMC, Quality, Supply Chain, Procurement, and Process Engineering colleagues.Leadership - Contribute as Global MSAT DP lead and as member of the Global Manufacturing Operations, with an aim to ensure effective and efficient delivery of our life-enhancing therapies to our patients.Travel - 10-30% travel required.
Requirements:Ph.D. degree in Chemical or Biochemical Engineering, Chemistry, Biochemistry, Analytical Chemistry or related discipline is required. Extensive experience in complex multivalent conjugation formulation and analytical technology highly preferred. Minimum of 12-15 years of relevant biotechnology or pharmaceutical industry (Process Development, MSAT, Operations, Quality, Supply Chain). At least 12 years of leadership experience in MSAT or other Process Development function in a Supervisory, People Leader role. Extensive experience in tech transfer, commercial launch, and lifecycle management of glycoconjugate vaccines preferred.The ability to create and articulate an inspiring vision for the global organization. The inclination to seek and analyze data from a variety of sources to support decisions and to align others with the organization's overall strategy. An entrepreneurial and creative approach to developing new, innovative ideas that will stretch the organization and push the boundaries within the industry. The ability to effectively balance the desire/need for broad change with an understanding of how much change the organization is capable of handling, to create realistic goals and implementation plans that are achievable and successful.
Executing for Results:The ability to set clear and challenging goals while committing the organization to improved performance, tenacious and accountable in driving results. Comfortable with ambiguity and uncertainty; the ability to adapt nimbly and lead others through complex situations. A leader who will be able to take calculated risks founded on data and input from others to foresee possible threats or unintended circumstances from decisions. A leader who is viewed by others as having a high degree of integrity and forethought in his/her approach to making decisions; the ability to act in a transparent and consistent manner while always considering what is best for the organization.
Leading Teams:The ability to attract and recruit top talent, motivate the team, delegate effectively, celebrate diversity within the team, and manage performance; widely viewed as a strong developer of others. The ability to persevere in the face of challenges and exhibit a steadfast resolve and relentless commitment to higher standards, which commands respect from colleagues.A leader who is self-reflective and aware of his/her own limitations; leads by example and drives the organization's performance with an attitude of continuous improvement by being open to feedback and self-improvement.
Relationships and Influence:Naturally connects and builds strong relationships with others, demonstrating strong emotional intelligence and an ability to communicate clearly and persuasively. An ability to inspire trust and followership in others through compelling influence, powerful charisma, passion in his/her beliefs, and active drive. Encourages others to share the spotlight and visibly celebrates and supports the success of the team. Creates a sense of purpose/meaning for the team that generates followership beyond his/her own personality and engages others to the greater purpose for the organization. Able to skillfully leverage deep technical knowledge in a collaborative manner to achieve collective goals.
Reports to: Vice President, MSAT
Location: San Carlos, CA
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
-
San Carlos, California, United States Vaxcyte, Inc. Full timeJoin 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...
-
San Carlos, California, United States Vaxcyte, Inc. Full timeJoin 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...
-
San Carlos, United States Vaxcyte, Inc. Full timeJoin 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...
-
San Carlos, California, United States Vaxcyte, Inc. Full timeJoin 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...
-
San Carlos, United States Vaxcyte, Inc. Full timeJoin 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...
-
Director, Drug Product Engineering
3 months ago
San Mateo, United States Vaxcyte Inc Full timeJob DescriptionJob DescriptionCompany Profile:Vaxcyte, Inc. (Nasdaq: PCVX) is a next-generation vaccine company seeking to improve global health by developing superior and novel vaccines designed to prevent some of the most common and deadly infectious diseases worldwide. Our exclusively licensed cell-free protein synthesis platform and our proprietary know...
-
Sr. Director, US Voxzogo Marketing Lead
4 days ago
San Rafael, United States BioMarin Pharmaceutical Inc. Full timeWho We Are Our Commercial organization leads our global sales and marketing strategies around the world. Our integrated team continues to solidify BioMarin’s commercial presence in the United States and Europe and is rapidly growing in other regions, such as Latin America, the Middle East and Asia-Pacific. The North America Brand Management...
-
Director, Quality Assurance Drug Product
1 month ago
South San Francisco, United States GQR Full timeTitle: Director, Quality AssuranceLocation: South San Francisco, CAHybrid: 3-4 days a week onsiteCompensation: Annual Salary of $230,000Annual bonus of 20%plus equity in shares of optionsWe are seeking an experienced professional to join our team as Director, of Quality Assurance.This candidate will be responsible for Quality Operations and oversight of...
-
Director, Quality Assurance Drug Product
1 month ago
South San Francisco, United States GQR Full timeTitle: Director, Quality AssuranceLocation: South San Francisco, CAHybrid: 3-4 days a week onsiteCompensation: Annual Salary of $230,000Annual bonus of 20%plus equity in shares of optionsWe are seeking an experienced professional to join our team as Director, of Quality Assurance.This candidate will be responsible for Quality Operations and oversight of...
-
San Francisco, United States SAIGroup Full timeAbout SAI GroupSAI Group is a private investment firm that has committed $1 billion to incubate and scale revolutionary AI-powered enterprise software application companies. Our portfolio, a testament to our success, comprises rapidly growing AI companies that collectively cater to over 2,000+ major global customers, approaching $600 million in annual...
-
Global Commercial Strategy Lead
11 hours ago
San Mateo, California, United States BeiGene Full timeAbout the RoleBeiGene is seeking a highly motivated and experienced Senior Manager to join our team as a Global Commercial Strategy Lead. As a key member of our commercial organization, you will play a critical role in developing and implementing global commercial strategies for our innovative oncology products.Key ResponsibilitiesSupport the development and...
-
Sr. Director, Global Sales Enablement
2 weeks ago
San Mateo, United States Visa Full timeCompany Description Visa is a world leader in payments and technology, with over 259 billion payments transactions flowing safely between consumers, merchants, financial institutions, and government entities in more than 200 countries and territories each year. Our mission is to connect the world through the most innovative, convenient, reliable, and secure...
-
Director, Global Marketing, Achondroplasia
4 weeks ago
San Rafael, California, United States BioMarin Pharmaceutical Inc. Full timeDirector Global Marketing, Achondroplasia For more than two decades, going our own way has led to countless breakthroughs, bettering the lives of those suffering from rare genetic disease. In 1997 we were founded to make a big difference in small patient populations. Now we seek to make an even greater impact by applying the same science-driven,...
-
Director, Global Marketing, Achondroplasia
4 weeks ago
San Rafael, United States BioMarin Pharmaceutical Inc. Full timeDirector Global Marketing, Achondroplasia For more than two decades, going our own way has led to countless breakthroughs, bettering the lives of those suffering from rare genetic disease. In 1997 we were founded to make a big difference in small patient populations. Now we seek to make an even greater impact by applying the same science-driven,...
-
Director of Regulatory Affairs
3 weeks ago
San Carlos, United States HealthCare Recruiters International Full timeOur client is a global leader in the development and commercialization of first-in-class robotic systems for the diagnosis and treatment of patients in need of advanced surgical interventions, including solid tumors. They have immediate need for a well-qualified Director of Regulatory Affairs to support an R&D team charged with developing effective small...
-
Director of Regulatory Affairs
3 weeks ago
San Carlos, United States HealthCare Recruiters International Full timeOur client is a global leader in the development and commercialization of first-in-class robotic systems for the diagnosis and treatment of patients in need of advanced surgical interventions, including solid tumors. They have immediate need for a well-qualified Director of Regulatory Affairs to support an R&D team charged with developing effective small...
-
Senior Director, Global Product Counsel
3 days ago
San Jose, California, United States eBay Full timeAbout the RoleeBay is a global commerce leader that connects millions of buyers and sellers around the world. We exist to enable economic opportunity for individuals, entrepreneurs, businesses, and organizations of all sizes.We are seeking a Senior Director, Global Product Counsel to join our legal team. As a key member of our team, you will provide legal...
-
Sr. Study Manager, Global Study Operations
5 days ago
San Rafael, United States BioMarin Pharmaceutical Inc. Full timeWho We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a...
-
Executive Director of Global Marketing
18 hours ago
San Mateo, California, United States Gilead Sciences Full timeAbout the RoleGilead Sciences is seeking a highly skilled and experienced Executive Director to lead our Global Commercial Strategy for HIV Global Strategic Marketing. As a key member of our team, you will be responsible for developing and executing a global commercial strategy that maximizes the overall value and access in current and pending...
-
**Product Director
5 days ago
San Francisco, California, United States SAIGroup Full timeAbout SAI GroupSAI Group is a private investment firm that has committed $1 billion to incubate and scale revolutionary AI-powered enterprise software application companies. Our portfolio, a testament to our success, comprises rapidly growing AI companies that collectively cater to over 2,000+ major global customers, approaching $600 million in annual...
