Product Transfer Scientist

1 month ago

Bengaluru Karnataka, India Cepheid Full time

At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development.

Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Together, we’re working at the pace of change on diagnostic tools that address the world’s biggest health challenges, driven by knowing that behind every test there is a patient waiting.

Learn about the Danaher Business System which makes everything possible.

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

**It would be a plus if you also possess previous experience in**:

- ** 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.**:
Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

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