Staff Technical Operations Manager - Kochi

Beckman Coulter Diagnostics; Kolkata District; On-site; INR 1,500,000 - 2,100,000; Full time

Job summary

Beckman Coulter Diagnostics is seeking a Staff Technical Operations Manager to ensure manufacturing of Beckman Coulter products in India by an OEM partner. The role covers technical operations, transfer, setup and validation of equipment and processes at the Kochi site.

You will report to the Director- Manufacturing Operations and work in a fast-paced team focused on product realization, transfer and ongoing support. Experience in IVD/Diagnostics and regulatory compliance is essential.

Qualifications

• Bachelor’s degree with 9+ years experience OR Master’s degree with 7+ years experience.
• Experience in IVD/Diagnostics/Medical devices industry in Operations/Manufacturing/Projects.
• Strong problem solving and leadership to deliver commitments.

Responsibilities

• Provide technical direction and support for third party manufacturing activities including coordination with cross-functional roles.
• Lead full project life cycle from initiation to deployment for multiple products, including equipment setup validation and process transfer.
• Coordinate with Manufacturing Support, Project Management, Technical Transfer, Supply Chain & Validation to ensure timely delivery.
• Drive and implement Supply Chain activities in compliance with local/global change processes and procedures.
• Ensure adherence to GMP compliance and regulatory requirements across activities.

Skills

Technical leadership

Project management

Regulatory compliance

Manufacturing operations

Problem solving

Education

Bachelor’s degree

Master’s degree

Job description

Bring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

Bring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
At Beckman Coulter Diagnostics, one of Danaher's 15+ operating companies, our work saves lives—and we're all united by a shared commitment to innovate for tangible impact.
You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life.
As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory's role in improving patient health for more than 90 years. Our diagnostic solutions are used in routine and complex clinical testing, and are used in hospitals, reference and research laboratories, and physician offices around the world. Every hour around the world, more than one million tests are run on Beckman Coulter Diagnostics systems, impacting 1.2 billion patients and more than three million clinicians per year. From uncovering the next clinical breakthrough, to rapid and reliable sample analysis, to more rigorous decision making-we are enabling clinicians to deliver the best possible care to their patients with improved efficiency, clinical confidence, adaptive collaboration, and accelerated intelligence.
Learn about the Danaher Business System which makes everything possible.
This Staff Technical Operations Manager for Beckman Coulter Diagnostics is responsible for ensuring the successful establishment of Beckman Coulter products being manufactured in India by an OEM partner. The role willinclude aspects of Technical Operations, Design & tech transfer Transfer, setup and validation of equipment and manufacturing processes.
This position is part of the Made in India transfer team located in India and will be located at the OEM manufacturing site Kochi. At Beckman Coulter, our mission is to Relentlessly Reimagine Healthcare, One Diagnosis at a Time.
You will be a part of the technical operations team and report to the Director- Manufacturing Operations who is responsible for successful implementation of BC products being manufactured in India.
If you thrive in a multifunctional, fast paced & supporting role and want to work in a Technical Operations Team and be involved in product realization, read on.

In This Role, You Will Have The Opportunity To

• Provide Technical direction and support for third party manufacturing activities including coordination of activities with cross-functional roles from Manufacturing Support, technical Operations, Project Management, Technical Transfer, Supply Chain & Validation.
• Be involved in the full project life cycle - successful project completion will include full implementation from initiation to deployment for multiple products, including equipment setup validation, manufacturing process transfer and validation, Test method transfer and validation, and post launch support.
• Support activities to ensure continuity and timely delivery of products to the market and ensure projects are effectively set up and meet their timelines.
• Use of DBS tools and techniques to streamline processes eg SW, TPI, VPM, Daily Management, etc. Support and coordinate development and technical approval for local sourcing of Raw and Packing Material
• Responsible for driving and implementing the Supply Chain Activities in compliance with the local and global design change process and relevant procedures.
• Coordinate with relevant groups across the Company to ensure that procedures / specifications, raw materials, resources and facilities are in place support the contractor manufacturing activities.
• Ensuring that all these activities are performed in a manner that ensures compliance with the relevant policy, procedures, regulatory authorities and GMP.

The Essential Requirements For The Role Include

• Bachelor’s degree with 9+ years experience OR Master’s degree with 7+ years experience.
• Proven experience in IVD/Diagnostics/ Medical devices industry in Operations/Manufacturing/ Projects ; Technical Acumen, problem investigation and problem solving skills are essential. Demonstrated ability to effectively prioritize and lead a team to deliver on commitments and meet the needs of the business.
• Prior experience managing similar projects.
• A good working understanding of cGMP and ISO/FDA requirements.

Beckman Coulter Diagnostics, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.
At Beckman Coulter Diagnostics we believe in designing a better, more sustainable workforce.
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.
For more information, visit www.danaher.com.