Technical Senior Program Advisor
Apply By: 29 May 2019
Location: New Delhi(Delhi)
About the Organization
Path is an international organization that drives transformative innovation to save lives and improve health, especially among women and children. It accelerates innovation across five platforms-vaccines, drugs, diagnostics, devices, and system and service innovations-that harnesses its entrepreneurial insight, scientific and public health expertise, and passion for health equity. By mobilizing partners around the world, it takes innovation to scale, working alongside countries primarily in Africa and Asia to tackle their greatest health needs. Together, it delivers measurable results that disrupts the cycle of poor health.
PATH CVIA is looking to hire a Technical Senior Program Advisor to serve as a subject matter expert to participate in and work closely with various CMC partners (e.g., emerging market vaccine manufacturers, and contract manufacturing organizations) on biologics (mainly vaccine, but also mAb) process development projects, and to monitor & evaluate process development projects across the CVIA portfolio, focusing on mammalian cell culture-based production systems for virus-based live/inactivated/recombinant subunit vaccines (including baculovirus) and mAbs, but also, at times, bacterial- and yeast-produced immunogens. Reporting to the Global Head of the CMC Functional Team, the Technical Senior Program Advisor will lead CMC development efforts and CMC subteams and will be responsible for a diverse set of activities on one or more product or technical assistance projects.
Job Duties and Responsibilities:
- Responsible for working with the Project Director(s), project team members, and partners to develop and execute the CMC strategy in integrated product development and lifecycle management plans consistent with the overall project goals across the entire CVIA CMC portfolio.
- Provide subject matter expertise to partners in the design, development, and implementation of process and product development (in the context of all CMC activities) for vaccines and biologics from the laboratory-scale through pilot plant and commercial manufacturing-scale.
- In conjunction with Project Management, ensure all CMC information is accounted for within project documentation including the Charter, project(s) scope, deliverables, schedules, and budget.
- Serve as primary point-of-contact with CMC partners and CMOs in the context of process development, ensuring both quality and timeliness of work.
- Oversee all aspects process development as it relates to the manufacturing and delivery of vaccines(s) for clinical trials.
- Active participant in the vendor/partner selection and manage/guide activities at vendor/partner, working closely and in partnership with CVIA CMC Quality Assurance and Commercialization Officers.
- Provide clinical development stage appropriate strategic direction, tactical oversight and technical expertise in up-stream and down-stream product/process
- In partnership with the CMC lead for tech transfer and lifecycle management formulate and recommend manufacturing approaches to maximize yields and reduce
- Represent CMC function as needed, including on project teams, task forces, audits and business or technical meetings with internal and external
- Write and/or review CMC sections for regulatory filings, including final technical review of CMC sections of regulatory
- Contribute to developing budgets for labor and capital
- Conduct technical (process development/manufacturing) due diligence of vaccines and mAb manufactures as
- Provide technical review of pharmaceutical plans and technical documentation relative to vaccine and mAb manufacturing facilities.
- Requires PhD in Biological Sciences with 15+ years of biopharma industry experience in all aspects of process/product
- Experience in upstream and downstream process development and validation for drug substance (DS) consistent with cGMP/ICH
- Demonstrated extensive experience in mammalian cell culture-based production systems for virus-based live/inactivated/recombinant subunit vaccines and mAbs for therapeutic use. Experience in bacterial- and yeast-based production systems is highly desired.
- Knowledge of and experience in selecting technologies appropriate for bacterial, viral and recombinant protein-based vaccines and mAbs.
- Demonstrated understanding and risk identification associated with process/product development and propose risk-mitigating solutions to internal/external stakeholders.
- Experience in guiding optimization of manufacturing of existing products for reduction of risks and/or costs and increase in robustness and capacity for
- History of working with partners in diverse geographic regions and
- Strong interpersonal skills including negotiations and conflict management are highly
- Willingness to travel (domestic and international) approximately 30%.
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