BioSpace, Inc.
Sr. Manager, Global Drug Product Commercialization
BioSpace, Inc., San Carlos, California, United States, 94071
Job Details
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:
*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.
Summary:
The Senior Manager for Drug Product (DP) Commercialization has the accountability for launch readiness and commercial supply of the Drug Product. The drug product strategy will transition from the Process Development organization to this role during late-stage product development. 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 support to ensure that the organization is equipped to effectively communicate the scientific and commercial rationale for DP 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.
This position will be reporting into the Senior Director for Global DP Commercialization. The Sr. Manager will collaborate on overall program strategy, with primary responsibility and accountability DP analytical and fill finish strategy.
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, Conjugation across all Drug Substances (DS). 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.Essential Functions:
DP Commercialization
- Provide strategic and scientific leadership for fill finish and analytical methods with internal and external stakeholders and ensure successful execution of launch plans and post launch commercial activities.Organization
- Provide technical representation for protein manufacturing processes. Support resourcing recommendations on staffing requirements to meet organizational goals.Process robustness
- Continuously improve process understanding and process robustness by putting systems in place to monitor, trend, and optimize operations.Interface
- Collaboration with cross-functional teams across the network, including Regulatory, CMC, Quality, Supply Chain, Procurement, and Process Engineering, to drive the successful development and commercial launch of carrier proteins for pipeline products.Tech-transfer new technologies
- Ensure robust processes exist to support technical transfers and integration of new technologies.Support technical services
- Support of our internal and external manufacturing network, including materials management and data analytics.Process validation and comparability
- Provide support for the execution of process validation and process comparability activities.Regulatory
- 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 commercialization.Communicate
- Effectively and efficiently communicate process performance to key stakeholders (internal-facing and external-facing). Connect and build strong working relationships with others, demonstrating strong emotional intelligence and an ability to communicate clearly and persuasively.Executing for Results
- Set clear and challenging goals and take accountability for driving results. Comfortable with ambiguity and uncertainty; the ability to adapt nimbly and move forward through complex situations.Leadership
- Provide technical leadership for DP Commercialization and contribute as a member of the Global Manufacturing Operations organization, with an aim to ensure effective and efficient delivery of our life enhancing therapies to our patients.Travel
- 10-30% travel required.
Requirements:
BA/BS in Chemical or Biochemical Engineering, Chemistry, Biochemistry, or related discipline with a minimum of 10 years relevant experience in the biotechnology/pharmaceutical industry. 8+ years with MA/MS and 5+ years with Ph.D.Broad experience in process characterization, product development, multivalent vaccines, and relevant fill finish unit operations across multiple operational scales.Experience with adjuvant physicochemical properties and interactions (specifically ALPO), resuspension and support of CMO's is a plus.Technical leadership experience in MSAT or Process or Product Development supporting technology transfer, project management and regulatory documentation.Able to leverage deep technical knowledge in a collaborative manner to achieve collective goals.Excellent organization, problem solving and strategic planning skills.Highly skilled in both verbal and written communication with the ability to interact effectively with people of diverse backgrounds and perspectives.Proactively recognizes needs and potential challenges and collaborates to implement effective solutions.The ability 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.
Reports to:
Senior Manager, Global Drug Product Commercialization Lead
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 (SF Bay Area). Salary ranges for non-California locations may vary.
Vaxcyte, Inc.825 Industrial Road, Suite 300San 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.
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:
*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.
Summary:
The Senior Manager for Drug Product (DP) Commercialization has the accountability for launch readiness and commercial supply of the Drug Product. The drug product strategy will transition from the Process Development organization to this role during late-stage product development. 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 support to ensure that the organization is equipped to effectively communicate the scientific and commercial rationale for DP 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.
This position will be reporting into the Senior Director for Global DP Commercialization. The Sr. Manager will collaborate on overall program strategy, with primary responsibility and accountability DP analytical and fill finish strategy.
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, Conjugation across all Drug Substances (DS). 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.Essential Functions:
DP Commercialization
- Provide strategic and scientific leadership for fill finish and analytical methods with internal and external stakeholders and ensure successful execution of launch plans and post launch commercial activities.Organization
- Provide technical representation for protein manufacturing processes. Support resourcing recommendations on staffing requirements to meet organizational goals.Process robustness
- Continuously improve process understanding and process robustness by putting systems in place to monitor, trend, and optimize operations.Interface
- Collaboration with cross-functional teams across the network, including Regulatory, CMC, Quality, Supply Chain, Procurement, and Process Engineering, to drive the successful development and commercial launch of carrier proteins for pipeline products.Tech-transfer new technologies
- Ensure robust processes exist to support technical transfers and integration of new technologies.Support technical services
- Support of our internal and external manufacturing network, including materials management and data analytics.Process validation and comparability
- Provide support for the execution of process validation and process comparability activities.Regulatory
- 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 commercialization.Communicate
- Effectively and efficiently communicate process performance to key stakeholders (internal-facing and external-facing). Connect and build strong working relationships with others, demonstrating strong emotional intelligence and an ability to communicate clearly and persuasively.Executing for Results
- Set clear and challenging goals and take accountability for driving results. Comfortable with ambiguity and uncertainty; the ability to adapt nimbly and move forward through complex situations.Leadership
- Provide technical leadership for DP Commercialization and contribute as a member of the Global Manufacturing Operations organization, with an aim to ensure effective and efficient delivery of our life enhancing therapies to our patients.Travel
- 10-30% travel required.
Requirements:
BA/BS in Chemical or Biochemical Engineering, Chemistry, Biochemistry, or related discipline with a minimum of 10 years relevant experience in the biotechnology/pharmaceutical industry. 8+ years with MA/MS and 5+ years with Ph.D.Broad experience in process characterization, product development, multivalent vaccines, and relevant fill finish unit operations across multiple operational scales.Experience with adjuvant physicochemical properties and interactions (specifically ALPO), resuspension and support of CMO's is a plus.Technical leadership experience in MSAT or Process or Product Development supporting technology transfer, project management and regulatory documentation.Able to leverage deep technical knowledge in a collaborative manner to achieve collective goals.Excellent organization, problem solving and strategic planning skills.Highly skilled in both verbal and written communication with the ability to interact effectively with people of diverse backgrounds and perspectives.Proactively recognizes needs and potential challenges and collaborates to implement effective solutions.The ability 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.
Reports to:
Senior Manager, Global Drug Product Commercialization Lead
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 (SF Bay Area). Salary ranges for non-California locations may vary.
Vaxcyte, Inc.825 Industrial Road, Suite 300San 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.