Vacancies at IAVI

Key Responsibilities:

Project and budget management

• Provide coordination and project management support for the Global Access team in executing a wide range of activities and initiatives.
• Support the contracting process for Global Access projects, including preparing background information, drafting scopes of work, managing inputs into Contract Central, preparing documentation, and ensuring timely progress. 
• Provide support for both virtual and in person meetings, including scheduling, preparing participant lists, sending invitations, tracking participants, identifying venues, coordinating meeting logistics.
• Support grant management, reporting, and proposal development for Global Access team.

Competitive intelligence and data analytics

• Conduct desk research, collate, and help analyze data including performing market intelligence; product and disease landscaping; partner and stakeholder mapping; literature reviews; mapping of funding and collaboration opportunities; and collection of other Access-related evidence, as needed.
• Support preparation of presentations, updates, briefs, proposals, and reports to support IAVI Global Access efforts.

Communications

• Provide general support to the team, including help with preparing background information and pre-reads for convenings, meeting minutes and summaries, tracking and leading select action items, and reporting. Develop PowerPoint presentations, for internal and external use.
• Manage feedback and approval processes for key materials shared externally.

Education and Experience:

• MPH/MA/MBA in a public health, life sciences, or a related field is required.
• Minimum of 5 years’ experience in global health, public health, health economics, market research or a related field is required.

Qualifications and Skills:

• Experience working for, or with, leading global organizations such as CHAI, USAID/PEPFAR, WHO, GAVI, the Wellcome, or other agencies as well as philanthropic organizations like the Bill and Melinda Gates Foundation is required.
• Demonstrated knowledge of global public health; access & delivery considerations; vaccines or monoclonal antibodies; HIV, TB, and EID prevention; and/or product development.
• Strong research and writing experience, with the ability to quickly research, analyze, and provide synthesized summaries of relevant data and information.
• Detail-oriented with a proven track record in managing complex, cross functional and multi-country projects and meeting deadlines.
• Proficiency in Microsoft Office (Excel, Word, Powerpoint) is required.
• Demonstrated ability to translate key Global Access content into compelling, visually appealing, and broadly accessible messaging is highly desirable.
• Self-motivated with strong interpersonal skills and a demonstrated ability to facilitate team interactions.
• Strong judgement, and the ability to take initiative and work independently, while identifying and escalating concerns as needed, are required.
• A team player with strong interpersonal skills and demonstrated ability to work collaboratively with others at all levels.

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Position Summary:

• Are you an ambitious Analytical Scientific Leader, experienced in Assay development, eager to lead vaccine and therapeutic development in a mission-driven organization?  
• IAVI is seeking an Associate Director OR Director, Analytical Science and Assay Development Viral vaccines to strategize and lead activities for the development of vaccines and biologics candidates important to human health for prophylactic and/or therapeutic use. This leader will address analytical needs of transitioning viral vectors from discovery into clinical testing in an effort to bring solutions to critical global health challenges. 

Key Responsibilities:

• Advise the relevant internal stakeholders with the FDA, EMA, ICH, WHO, regulatory, and pharmacopeia guidelines and compliance requirements for biologics.
• Develop and implement evolving analytical packages that span all the way through from research to a regulated compliance environment (R&D and GXP).
• Build assay packages that ensure product CQAs are maintained during expression, purification, and storage of DS and DP of biologics.
• Translate research techniques from in-house and external developers into SOPs for tech transfer.
• Participate within the Product Development Project teams, developing technical work plans through different phases of development through to cGMP manufacturing and product release to support IND enabling activities.
• Collaborate on grant applications, writing grants, and developing budgets to secure funding.
• Author and review technical and scientific documents including but not limited to method development reports, qualification/ validation protocols and reports, SOPs, and test methods.
• Author and review CMC IND sections for regulatory submission.
• Maintain analytical data integrity in compliance with industry good documentation practices (GDP).
• Ensure that testing methodologies meet phase-appropriate cGMP requirements.
• Work with internal subject matter experts to write and review analytical test method, protocols, and development reports.
• Perform any other duties as assigned by the Manager.

Education and Experiences:

• PhD in analytical chemistry or a related field is highly preferred; Advanced degree is required.
• Educational experience focused on biological analysis is highly preferred.
• Minimum 8 years of experience in biologics CMC development with PhD OR minimum of 10 years’ experience with advanced degree required Level to be determined based on expertise and experience in field.
• Experience in vaccine development and outsourcing pharma bioanalysis, with an emphasis on virus-based vaccines is required.

Qualifications and Skills:

• Experience in cGxP (e.g. GRP, GMP, GLP) is required.
• Experience with the testing of Vaccines and Therapeutics, consistent with International Standards e.g., ICH, US FDA and EMA requirements is required; Experience with live attenuated viruses and/or gene therapy vectors highly preferred.
• Experience working in an FDA Regulated Environment (Pharmaceuticals or Biologics) for analytical development of cGMP biologicals for pre-clinical, and clinical evaluation is required.
• Experience with the development, qualification, and validation of standard analytical tests for viral vaccines (e.g., virus infectivity, qPCR, RT-PCR, SDS-PAGE, western blots, sequencing, Next Generation Sequencing, ELISA) for Late-Stage development is highly preferred.
• Experience in developing, qualifying, and validating large molecule analytical methods including HPLC, capillary electrophoresis (CE), and biologics characterization is required.
• Experience in writing SOPs and technical transfer and training is required.
• Experience developing and implementing an evolving analytical package that spans all the way through from research to a regulated compliance environment (R&D and GXP) is required.
• Understands the scientific principles underpinning the critical quality attributes (CQA) of drug substance (DS) and drug product (DP). Experience in building an assay package that ensures that CQAs are maintained during expression, purification, and storage of DS and DP of biologics is required.
• Technical understanding of Vaccines and Therapeutics development and knowledge of Quality Assurance (QA) considerations for cGxP activities.
• Excellent verbal, written, and presentations skills are required.
• Track record of working in a multi-cultural environment with the ability to influence and generate consensus is required.

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Key Responsibilities:

• Collaborate with the scientific project leaders to develop an integrated project plan.
• Lead task order projects and/or internal projects to ensure on time delivery with a high level of stakeholder engagement and communication.
• Assist in the development of vaccine/therapeutics, in collaboration with another PM (Director or above) , the scientific leader and internal and external cross-functional teams.
• Lead and facilitate cross-functional team communications and project meetings with internal and external stakeholders with respect to project/product strategy, tactics, key performance indicators, budget, deadlines, deliverables, constraints, and risks.
• Drive and synergize cross-functional collaboration to achieve project milestones as defined by the baseline plan.
• Routinely generate score cards using metrics such as key performance indicators (KPI’s) to analyze, measure project performance, derive lessons learnt with a sharp focus on continuous improvement of project metrics.
• Provide project status reporting (progress, budget, issues) with internal, external stakeholders, and funders, as well as prepare status reports as required for each funder/stakeholder group (e.g., monthly, quarterly, annually).
• Support best project management practices in a fast project/product development environment including continuous improvement.

Education and Work Experience:

• Bachelor's degree in Project Management and/or Life Sciences or related degree is required. Master's degree is preferred.
• Minimum 8 years of biopharmaceuticals (vaccines or biologics or therapeutics) experience in product development and/or project management is required.
• Project Management Professional certification is highly desirable.

Qualifications and Skills:

• Demonstrated leadership experience, including experience influencing, engaging, and coordinating cross-functional teams of scientists, clinicians, executives, and funders is required.
• Excellent organizational, written, verbal, and presentation skills are required.
• Excellent judgment skills with the ability to present programs to scientific and non-scientific stakeholders.
• Results-driven, focused, and detail oriented.
• Strong negotiation experience are required.
• Proficient in MS Office (Outlook, Word, PowerPoint, Excel) and MS Project is required. Smart Sheet proficiency is desirable.
• Knowledge of GXPs, quality assurance, and regulatory affairs associated with biopharmaceutical development is highly desirable.
• Experience with international projects is highly desirable.