Location
Secunderabad | India
Job description
Main purpose of the Job: Lead the Vaccines and Biologics R&D which have the industry's broadest pipeline of vaccine/novel biologics development programs & excel in cost intensive research for development of pharmaceuticals - dedicated to progressing vaccine science and technologies and increase access to affordable medication to mankind across the globe.
Responsbilities
- Lead product development (Early & Later Development stages) of products from aiding conception of ideas, to development and finally managing the life cycle from submission to approval.
- Should have experience in discovery and development of Vaccines or Biologics) in the US through USFDA, other continents like EU, Africa, Rest of the world would be an added advantage.
- Should have a fair understanding and should have worked with big R&D team (200+ or more) including broad segments like: Discovery, Product Development & Clinical Development which includes Molecular Biology, mRNA, Bioprocess Development (Fermentation, Virology, Downstream, Analytical, Conjugation, Formulation R&D), Immunology, Serology and Clinical Development.
- Should have experience in product development of novel biologics related to Vaccine / Oncology / Gene Therapy/ mRNA / A Chimeric Antigen Receptor Targeting C Type Lectin
- Experience in end-to-end product development, design and development, scale up, in-vitro and in-vivo clinical study design
- Good learning and strong knowledge preferred on health care segment globally to understand the target markets in various countries with vision towards future on upcoming needs and advise business on the product portfolios which may be the need of the world in future
- To sustain & make the company as a preferred world best Vaccine/Biologics Organisation by being future ready for various types of diseases and Pandemics including non-communicable diseases like Cancer
- Hands on experience on Regulatory Audit agencies like USFDA, WHO, UNICEF, Health Ministries of various countries in handling the R&D clearance
- Develop strategies and absolute discipline on products cycle management by fostering strong execution plans inclusive of backup plans to mitigate the risk of delivering the product beyond planned timelines which is inclusive of project management to ensure there is no loss of any opportunity
- Align with business plan as per the product portfolio requirements in alignment with the business plan of products and their commercialisation with strict adherence to business timelines.
- Ensure highest level of Compliance as applicable to various products, stake holders / committee / forums etc. as required
Desired experience:
- Professional with over 15-20+ years of extensive experience in Product Development & commercialisation.
- Should have relevant experience in setting up R&D – Discovery Research Labs in the US in the near future.
- Strong high level of business written communication skills.
- Strong understanding and empathy for various stakeholders.
- Should be highly communicative & reciprocative to clients which is very crucial.
- High level of Quality delivery standards to enhance the place in international market.
Job tags
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