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Product Transfer Scientist
OTT HydroMet
posted 1mon ago
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Flexible timing
Key skills for the job
Job Description
We are currently seeking a Product Transfer Scientist who will be responsible for key role in Manufacturing Science/Operations located in Bengaluru, Karnataka (on-site) by combining proficiency in molecular biology/real-time PCR and a technical understanding of Cepheid assays to implement key changes to raw materials, reagents, processes, and/or product structure. Partners with multiple departments to create/sustain robust processes that support molecular diagnostics assay manufacturing. Implements product improvements to ensure product quality, sustain manufacturability, and improve margins of Cepheid assays.
In this role, you will be responsible for:
- Lead the development and implementation of reagent and process improvements required for ensuring post-launch product quality, manufacturability, scale-up, and cost effectiveness.
- Oversee the execution of manufacturing transfer for assays and the launch of new product introductions (NPI).
- Effectively collaborate on cross-functional projects with an efficient use of resources and timelines. Act as liaison and align with functions such as manufacturing, engineering, R&D, quality, supply chain, and regulatory to ensure processes are robust and sustainable.
- Conduct experiments in support of test method and or process validation/qualification activities and process improvement projects. Complete plans/reports and update all relevant documentation (e.g., BOMs, SOPs, batch records, design history files, etc.).
The required qualifications for the job include:
- Bachelor s degree with 3+ years of related work experience OR master s degree in field with 0-2 years of related work experience.
- Experience with and proficient knowledge of real-time PCR and molecular diagnostic assays.
- Experience in authoring documentation such as SOPs and reports.
Physical requirements/abilities:
- Ability to work in office, laboratory and production environment
- Flexible to work in shifts and weekends
- Hands-on experience in Operations functions, including an understanding of specifications, batch records, bills of materials, logistics and inventory parameters, costing parameters, document management systems, and/or ERP systems.
- Experience working in a regulated manufacturing operations environment under cGMP, ISO and/or FDA regulations.
- Experience with any of the following: control materials, enzyme/protein production, and lyophilization.
Employment Type: Full Time, Permanent
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