Group Leader- Regulated market products and in-silico Fresher's job
1 year ago Engineering Mumbai 90 views Reference: 28574Job Details
Job Purpose
Leads the diagnostic device development journey from design, minimum viable product and manufacturing of the approved portfolio devices. Seamlessly drive people management, cost management and approvals of external manufacturers, thereby contributing to IPD’s overall product strategy and ensuring on time, within budget delivery of these devices.
Key Accountabilities (1/6)
Act as an in-house expert on medical devices to support the IPD growth strategy
- Provide inputs related to medical devices to internal departments within IPD which can be factored and shared with the product selection committee
- Operate as the point of contact for all queries related to medical devices from internal departments
Key Accountabilities (2/6)
Cost management of combination products and in-silico programs at the department
- Define and integrate Cost of development, acquisition, venturing, scale up/tech-transfer and cost of production for all pipeline programs
- Work with HoD to build clean sheet costing for strategic priorities so that procurement and sourcing teams can drive the relevant negotiations
Key Accountabilities (3/6)
Lead the cross functional group of pharmaceutical, engineering associates to deliver combination product projects
- Support the delivery of key strategic products for IPD by expanding the portfolio of medical devices to accompany the various drugs
- Interact with departments across IPD to understand the requirements for different devices as per the various drugs
- Ensure compliance of devices to relevant regulations and quality norms
- Identify and select design houses related to the specific device, provide inputs to develop the product and submit for approval
- Coordinate the flow of inputs between internal departments and design houses in order to align on the specifications of the required device
- Ensure on time and accurate documentation of the design and development process across its various stages
- Conduct root-cause analysis of product rejections and recommend measures to reduce rejection rates
Key Accountabilities (4/6)
Develop and monitor new vendor partnerships for the in-silico methods including inhouse capability building to carry out these methods
- Introduce shortlisted vendors to the Dept. Head
- Conduct due diligence of vendors to ensure compliance to standards, in-silico method accuracies.
- Coordinate on the different parts/equipment required for each device, identify and shortlist providers for the same and share with the procurement team
- Monitor the production process of each of the devices with existing vendors to ensure OTIF delivery
Key Accountabilities (5/6)
People Management for the group
- Define growth trajectories, career ladder, development plans for the group leaders, associates and the incumbents and align with HR partners.
- Work closely with HoD for skillset mapping, identify technical and soft skill development opportunities and design training plans
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