Technical Advisor - Chemistry Manufacturing
- United States
- 10 - 15 years
- Hyderabad
- 5 years ago
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Job Description
Summary of the Position
- This a strategic level position in order to expand competencies in vaccines and other medical products manufacturing.
- The incumbent will be responsible for providing technical assistance and oversight to manufacturers and regulators to achieve the objectives of increasing the supply of quality-assured vaccines and essential medical products.
- The incumbent will interface with internal USP departments as well as regulators and manufacturers of medical products.
Roles and Responsibilities
- Lead in the provision of PQM+ technical assistance and oversight to manufacturers and regulators to achieve the objectives of increasing the supply of quality-assured vaccines and essential medical products.
- Provide technical assistance to manufacturers in GLP, GMP, technology transfer, and dossier development and submission through audits, trainings, and deployment of tools and approaches to ensure adoption of international quality standards.
- Provides oversight for local CMC staff, local partners and consultants involved in delivery of manufacturing support
- Identify CMC risks and support the development of mitigations and contingency plans.
- Conduct audits to assess compliance with international standards from WHO Technical Report Series of the Expert Committee of Biological Standardization, WHO Prequalification process for vaccines and biotherapeutic products and support manufacturers to develop strategies and tools to address deviations and non-compliance identified.
- Support LMIC regulatory inspectorates to develop manuals and SOPs for inspection of vaccines and sterile manufacturing facilities.
- Work closely with teams to support development and deployment of strategies in vaccine sector development
- Supports the work and efforts of the Senior Technical Advisor, Product Supply Management and CMC to develop technical documents on the manufacturing of quality vaccines and other medicines
- Keep abreast of the latest analytical technology in industry and regulation requirements
- Technical POC at global level
- Recognized leader actively advancing and deploying new technologies and trends in vaccines manufacturing
- Represents USP and PQM+ Program in local and regional forums on manufacturing
- Actively contribute to annual programmatic and resource planning process and contribute to programmatic growth.
Basic Qualifications
- Minimum of 10 years of experience in vaccines and biologics manufacturing
- Subject matter expert in vaccine/biopharmaceutical manufacturing processes, comparability/feasibility studies, stability studies, analytical development, and regulatory filings
- Thorough understanding of Chemistry, Manufacturing and Controls and Good Manufacturing Practices for medicines and vaccines e.g. fill and finish, packaging and other relevant areas
- Experience working with vaccine technologies
- Knowledge of regulatory requirements related to the development and manufacture of medicines and/or biologics in all phases of clinical development
- Direct experience with regulatory authority registration processes
- Bachelors degree in pharmacy, pharmaceutical science, chemistry, engineering or science related field of study required
- Strong written (especially technical writing) and oral communication skills
- Willingness to travel up to 25% of the time
Preferred Qualifications
- Direct experience implementing USAID-funded programs
- Minimum of 5 years people management experience and skills
- Experience in at least one of the following health areas: HIV/ AIDS, malaria, TB, NTDs, AMR, MNCH
- Experience with including water systems, sterility, HVAC, contamination, analytical chemistry, cleaning procedures, validation, bioprocessing, separation, purification, formulations and other relevant areas
- Experience working with a range of vaccine technologies that can include bacterial fermentation, egg-based vaccines, protein sub-units, viral vectors, and mRNA
- Direct experience with and understanding of WHO vaccine pre-qualification and/or other regulatory authority registration processes
Job Classification
Industry: Pharmaceutical & Life SciencesFunctional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology, Role Category: R&DRole: R&DEmployement Type: Full timeEducation
Under Graduation: Any GraduatePost Graduation: Post Graduation Not RequiredDoctorate: Any DoctorateContact Details:
Company: United StatesLocation(s): Hyderabad+ View Contact
Keyskills: HVAC Technical writing Pharma Pharmacy Stability studies Packaging clinical development GLP GMP Subject Matter Expert
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