About the Role
The purpose of this role is to ensure a consistent and reliable supply of complex sterile biological and biosimilar products by supporting contract manufacturers with expert technical guidance. It involves troubleshooting manufacturing challenges, conducting detailed due diligence, and delivering key projects such as site transfers, material changes, and process improvements. The role also provides critical technical support to internal stakeholders, ensures compliance with licensing and manufacturing standards, and serves as a subject matter expert who can communicate complex concepts, anticipate risks, and influence strategic decisions.
What You’ll Do:
Expert knowledge in the technical/manufacturing domain for sterile, biological / biosimilar products and beyond the specific area / across a wide range of the GxPs.
Capable of presenting as a subject matter expert during health authority inspections / cross-functional discussions. Point of contact for cross-functional teams for the associated technical area.
Author,
review and approval of technical documentation independently e.g., technical justifications, RFI responses, technical summary reports for complex regulatory submissions.
Provide technical solutions during troubleshooting and provide expertise for associated activities across business units for the lifecycle management of routinely manufactured products or new products
Lead due diligence risk analysis / due diligence for current products/acquisitions and manufacturing changes, including an overview of process/packing validation-related activities
Deliver specific projects that include site transfers, changes to material sources, reformulation, and process improvement with a high degree of complexity. Project management of assigned life cycle maintenance activities and ensure timely reporting of updates.
Provide technical services to support internal stakeholders, and provide expert inputs to License
📌 Technical Support Specialist (Mumbai)
🏢 Advanz Pharma
📍 Mumbai
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