Vice President, Head of Manufacturing at International AIDS Vaccine Initiative
1 month ago
The International AIDS Vaccine Initiative is a global not-for-profit, public-private partnership working to accelerate the development of vaccines to prevent HIV infection and AIDS.
Position Summary:
Are you a passionate Life sciences manufacturing leader in who’s eager to translate science into global health solutions? If you are a GMP manufacturing expert with extensive leadership experience as well as vaccine experience, learn more and apply below
IAVI is seeking an Experienced Leader who has depth of expertise in all phases of manufacturing processes, including drug substance, drug product, and development of analytical control strategies. The Head of Manufacturing is accountable for process design, leading internal and external partners to establish critical quality attributes of drug substance, drug product, qualifying raw materials throughout the R&D life-cycle. The Head of Manufacturing is a GMP expert, as well as a seasoned leader who drives strategic decisions impacting the scale-up and development of best-in-class vaccines and treatments.
Key Responsibilities:
Accountable for product and process development, scientific and engineering quality, and ensures all product quality attributes are understood and controlled through manufacturing and analytical controls.
Partners with leadership on cross-functional teams to deliver and maintain processes and controls that are timely, phase-appropriate, and compliant, to meet clinical and commercial supply needs.
Understands and responds to business priorities and translates these into tactical objectives and work direction.
Mitigates risks to production schedules and program deliverables when necessary and ensures an effective tech transfer/process.
Develops and executes a plan for validating the manufacturing process for IAVI’s portfolio of programs, each at various stages of development.
Work with functional expertise throughout IAVI to conduct risk assessments for critical processes and develop mitigations plans.
Collaborate with internal and external partners to develop and validate plans for at-scale production and drive the execution of these plans.
When required, define protocols for tech transfers and facilitate evaluation and processes to ensure successful design of production, ensuring GMPs are fully integrated.
Work with internal stakeholders (e.g., Regulatory) to ensure validation strategies fit within IAVI and our funders strategy.
Collaborate with project management to maintain a detailed timeline for the activities that must be completed – communicate to team when activities are at risk of causing delays to timeline.
Manage manufacturing to support commercial production.
Understand process and analytical requirements for the entire process.
Communicate process requirements to facilities engineers fit for purpose design.
Creatively apply experience to ensure process design specifications are met on time and with high quality standards.
Manage contract manufacturing oversight activities, such as reviewing of pre-campaign documentation, batch records, deviations, and approving batch release documentation.
Requirements
Education and Work Experience:
Advanced degree or PhD in Biochemistry, Chemistry, Chemical or Bioprocess Engineering, Biology, or related field is required.
Minimum of 15 years’ experience in biopharmaceutical/pharmaceutical manufacturing environment, with a minimum of 5 years’ senior management experience.
Experience in early and late-stage product development, ideally having successfully been involved with bringing a product(s) to licensure.
Qualifications and Skills:
Prior vaccines manufacturing experience is required.
In depth experience with technology transfer and process validation is required.
Experience overseeing CMOs and partnering with these organizations to drive results is required.
Ability to dissect a manufacturing issue, conduct root cause assessments, and design experiments to test hypotheses stemming from manufacturing observations.
Strong ability to motivate, mentor, and connect with peers and team members.
Experience with CRO oversight, ensuring compliance with relevant regulatory standards required.
Experience successfully managing and utilizing project management tools
Ability to work across teams and SMEs to integrate information into centralized plans.
Curiosity and drive to quickly come up to speed; creativity to solve challenging problems.
Strong interpersonal skills, with excellent written and verbal communication skills.
Ability to travel domestically and internationally as needed.
A mission-driven individual with high energy and high levels of perseverance; works towards both individual and team goals.
-
Nairobi, Kenya International AIDS Vaccine Initiative (IAVI) Full timeThe International AIDS Vaccine Initiative is a global not-for-profit, public-private partnership working to accelerate the development of vaccines to prevent HIV infection and AIDS. Position Summary: Are you an experienced Medical Writer who is eager to help translate science into global health solutions? Summary IAVI is seeking an experienced...
-
Nairobi, Kenya International AIDS Vaccine Initiative (IAVI) Full timeThe International AIDS Vaccine Initiative is a global not-for-profit, public-private partnership working to accelerate the development of vaccines to prevent HIV infection and AIDS. Position Summary: Are you an ambitious and experienced Global Access professional eager to make a positive impact in public health? IAVI is seeking a Manager, Global...
-
Nairobi, Kenya International AIDS Vaccine Initiative (IAVI) Full timeThe International AIDS Vaccine Initiative is a global not-for-profit, public-private partnership working to accelerate the development of vaccines to prevent HIV infection and AIDS. Summary IAVI is seeking Legal Counsel to support our Africa operations. The Legal Counsel will serve in the General Counsel’s office, providing legal support across a...
-
Associate, Advocacy, Policy
3 weeks ago
Nairobi, Kenya International AIDS Vaccine Initiative (IAVI) Full timeThe International AIDS Vaccine Initiative is a global not-for-profit, public-private partnership working to accelerate the development of vaccines to prevent HIV infection and AIDS. Position Summary: IAVI is seeking an ambitious Associate, Advocacy, Policy & Communications to help drive and execute critical initiatives critical to IAVI’s mission of...
-
Nairobi, Kenya International AIDS Vaccine Initiative (IAVI) Full timeThe International AIDS Vaccine Initiative is a global not-for-profit, public-private partnership working to accelerate the development of vaccines to prevent HIV infection and AIDS. Position Summary: IAVI is seeking an Associate Director, Resource Mobilization who’s experienced in fundraising, proposal management, and eager to help us advance our...
-
Nairobi, Kenya International AIDS Vaccine Initiative (IAVI) Full timeThe International AIDS Vaccine Initiative is a global not-for-profit, public-private partnership working to accelerate the development of vaccines to prevent HIV infection and AIDS. Position Summary: IAVI is seeking an Associate Director, Resource Mobilization who’s experienced in fundraising, proposal management, and eager to help us advance our...
-
Nairobi, Kenya International AIDS Vaccine Initiative (IAVI) Full timeThe International AIDS Vaccine Initiative is a global not-for-profit, public-private partnership working to accelerate the development of vaccines to prevent HIV infection and AIDS. Summary IAVI is seeking a highly motivated Senior Clinical Trial Manager (CTM) who manages, oversees and executes day-to-day operational activities for the conduct of...
-
Nairobi, Kenya Safety and Security Consultant at International AIDS Vaccine Initiative (IAVI) Full timeThe International AIDS Vaccine Initiative is a global not-for-profit, public-private partnership working to accelerate the development of vaccines to prevent HIV infection and AIDS. Responsibilities The consultancy deliverables include, but are not limited to: Producing a detailed Security Risk Assessment report for West Africa that entails a risk...
-
Vice President, Africa at
5 days ago
Nairobi, Nairobi Area, Kenya Conservation International Full timeConservation International is an American nonprofit environmental organization headquartered in Arlington, Virginia. Its goal is to protect nature as a source of food, fresh water, livelihoods and a stable climate.SummaryReporting to the Senior Vice President (SVP), the Vice President (VP) for the Africa Field Division assumes a pivotal role in providing...
-
Nairobi, Kenya Conservation International Full timeConservation International is an American nonprofit environmental organization headquartered in Arlington, Virginia. Its goal is to protect nature as a source of food, fresh water, livelihoods and a stable climate. Summary Reporting to the Senior Vice President (SVP), the Vice President (VP) for the Africa Field Division assumes a pivotal role in...
-
Vice President
4 weeks ago
Nairobi, Nairobi Area, Kenya International Rescue Committee (IRC) Full timeThe International Rescue Committee is a global humanitarian aid, relief and development nongovernmental organization.Job OverviewThe Vice President of Talent & Organizational Effectiveness is a pivotal leadership position, blending innovative strategic oversight with hands-on operational acumen to reshape and enhance our organizational structure and talent...
-
Nairobi, Kenya International Vaccine Institute (IVI) Full timeThe International Vaccine Institute (IVI) is an nonprofit International Organization IVI, through its mission to discover, develop and deliver safe, effective and affordable vaccines, enables the world’s most vulnerable people to live full, productive lives by accelerating R&D for crucial vaccines with partners in the Republic of Korea, across Asia, and...
-
Associate Director, Medical Writing at
4 weeks ago
Nairobi, Nairobi Area, Kenya International AIDS Vaccine Initiative (IAVI) Full timeThe International AIDS Vaccine Initiative is a global not-for-profit, public-private partnership working to accelerate the development of vaccines to prevent HIV infection and AIDS.Position Summary:Are you an experienced Medical Writer who is eager to help translate science into global health solutions?SummaryIAVI is seeking an experienced Medical Writer to...
-
Associate, Advocacy, Policy
3 weeks ago
Nairobi, Nairobi Area, Kenya International AIDS Vaccine Initiative (IAVI) Full timeThe International AIDS Vaccine Initiative is a global not-for-profit, public-private partnership working to accelerate the development of vaccines to prevent HIV infection and AIDS.Position Summary: IAVI is seeking an ambitious Associate, Advocacy, Policy & Communications to help drive and execute critical initiatives critical to IAVI's mission of...
-
Vice President
4 weeks ago
Nairobi, Kenya International Rescue Committee (IRC) Full timeThe International Rescue Committee is a global humanitarian aid, relief and development nongovernmental organization. Job Overview The Vice President of Talent & Organizational Effectiveness is a pivotal leadership position, blending innovative strategic oversight with hands-on operational acumen to reshape and enhance our organizational structure and...
-
Manager, Global Access at
4 weeks ago
Nairobi, Nairobi Area, Kenya International AIDS Vaccine Initiative (IAVI) Full timeThe International AIDS Vaccine Initiative is a global not-for-profit, public-private partnership working to accelerate the development of vaccines to prevent HIV infection and AIDS.Position Summary:Are you an ambitious and experienced Global Access professional eager to make a positive impact in public health?IAVI is seeking a Manager, Global Access to...
-
Country Office Head, Kenya at
4 weeks ago
Nairobi, Nairobi Area, Kenya International Vaccine Institute (IVI) Full timeThe International Vaccine Institute (IVI) is an nonprofit International Organization IVI, through its mission to discover, develop and deliver safe, effective and affordable vaccines, enables the world's most vulnerable people to live full, productive lives by accelerating R&D for crucial vaccines with partners in the Republic of Korea, across Asia, and...
-
Associate Director, Resource Mobilization at
2 days ago
Nairobi, Nairobi Area, Kenya International AIDS Vaccine Initiative (IAVI) Full timeThe International AIDS Vaccine Initiative is a global not-for-profit, public-private partnership working to accelerate the development of vaccines to prevent HIV infection and AIDS.Position Summary:IAVI is seeking an Associate Director, Resource Mobilization who's experienced in fundraising, proposal management, and eager to help us advance our mission of...
-
Legal Counsel at
4 weeks ago
Nairobi, Nairobi Area, Kenya International AIDS Vaccine Initiative (IAVI) Full timeThe International AIDS Vaccine Initiative is a global not-for-profit, public-private partnership working to accelerate the development of vaccines to prevent HIV infection and AIDS.SummaryIAVI is seeking Legal Counsel to support our Africa operations. The Legal Counsel will serve in the General Counsel's office, providing legal support across a wide range of...
-
Senior Clinical Trial Manager at
4 weeks ago
Nairobi, Nairobi Area, Kenya International AIDS Vaccine Initiative (IAVI) Full timeThe International AIDS Vaccine Initiative is a global not-for-profit, public-private partnership working to accelerate the development of vaccines to prevent HIV infection and AIDS.SummaryIAVI is seeking a highly motivated Senior Clinical Trial Manager (CTM) who manages, oversees and executes day-to-day operational activities for the conduct of clinical...
