Sr DGM

1 week ago

Mumbai, Maharashtra, India USV PRIVATE LIMITED Full time

USV Biologics is hiring

We are a 63 year old healthcare company recognized for our leadership in the oral antidiabetic & cardiovascular disease therapeutic segments in India. Our Biologics Program comprises molecular biology, upstream and downstream, analytical and bioanalytical teams and biologics regulatory affairs operating out of Govandi, Mumbai. USV's first commercialized biosimilar, Pegfilgrastim (GRASUSTEK) has received marketing authorization in the EU and some other countries and has been marketed for the past 5 years.

USV Biologics is expanding into mammalian biosimilars and is building a team for the Mammalian program in R&D.

We invite applications from Sr leaders with a strong background in biotechnology, cell biology, bioprocessing with around 20 years of significant experience. This position will be based at our Corporate Office and R&D Center at Govandi ( East), Mumbai.

The said position is a Senior role requiring strong scientific leadership, strategic planning skills, excellent communication & interpersonal skills and a proven track record in mammalian cell culture process development, optimization and scale up.

Key Responsibilities :

  • Develop and implement long-term strategies for mammalian process development, ensuring alignment with business goals.
  • Support the development, optimization, and scale-up of mammalian cell culture processes for various mammalian biosimilars, from early research to commercial manufacturing.
  • Lead and mentor a team of upstream and downstream scientists, fostering a culture of collaboration, innovation and excellence.
  • Work closely with cross-functional teams –analytical, formulation, regulatory affairs, production, quality and program management –to ensure seamless process transfer and compliance.
  • Monitor and evaluate process performance, identify and resolve technical challenges, drive innovation in process development and implement process improvements.
  • Manage budgets and allocate resources effectively to support process development activities.
  • Identify new technologies and application of latest scientific knowledge
  • Author/review process development documents, regulatory dossiers etc
  • Ensure compliance with R&D QA, relevant regulatory requirements and guidelines for biosimilars
  • Identify and develop team leads to the capable level of leaders in future.
  • Guiding the team to develop a process feasible to regulated and non regulated markets.

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