Production Operations Manager

4 days ago

Bengaluru, Karnataka, India Cambrian Bioworks Full time

As a key member of our team at Cambrian Bioworks, you will play a crucial role in ensuring the smooth operation of our manufacturing processes. This exciting opportunity allows you to leverage your expertise in production management and contribute to the success of our cutting-edge medical devices.

About the Role

We are seeking an experienced Production Operations Manager to oversee the daily activities of our production team. In this role, you will be responsible for maintaining high-quality standards, adhering to regulatory requirements, and driving process improvements. Your extensive knowledge of cleanroom protocols, buffer preparation, and automated filling machinery will be invaluable assets to our team.

The ideal candidate will possess strong leadership skills, excellent communication abilities, and a passion for quality control. If you are a motivated and results-driven professional looking for a challenging role that offers opportunities for growth and development, we encourage you to apply.

About the Job Description
  • Job Title: Production Operations Manager
  • Location: Bangalore, India

Our company designs and manufactures automated medical devices for precision diagnostics. We take pride in innovation, quality, and compliance in all aspects of our operations. As a Production Operations Manager, you will work closely with cross-functional teams to ensure seamless collaboration and effective problem-solving.

Key Responsibilities:

  • Prepare buffers and solutions according to pre-approved standard operating procedures (SOPs) and batch production records.
  • Measure and weigh chemicals with precision using calibrated equipment.
  • Accurately measure, mix, and prepare reagents according to standardized formulation, procedures, and specifications.
  • Perform Buffer Filtration. Monitor and adjust pH levels, as required, ensuring compliance with batch specifications.
  • Assist in investigations and deviations related to buffer preparation processes.
  • Operate within a classified cleanroom environment while adhering to proper aseptic techniques and gowning procedures.
  • Maintain cleanliness of the workspace, ensuring compliance with GMP, GLP, and ISO standards.
  • Perform manufacturing operations, such as automation machine setup & functional checks, periodic inspection of filling, and packaging, in a controlled clean room environment following standard work instructions.
  • Adhere to strict gowning and de-gowning procedures to maintain cleanliness and prevent contamination of the clean room environment.
  • Handle and transport materials, components, and finished products within the clean room environment, following proper procedures to prevent contamination and maintain product integrity.
  • Ensuring that the manufactured products meet quality standards by conducting visual inspections, measurements, and other quality checks as per SOP throughout the manufacturing process.
  • Identifying and addressing any issues that arise during the manufacturing process, such as equipment malfunctions or deviations from quality standards.
  • Performing routine maintenance and cleaning of production equipment to ensure optimal performance.
  • Accurately complete manufacturing documentation, including batch records, log sheets, and inspection reports, to ensure traceability and compliance with regulatory requirements.
  • Contributing to continuous improvement efforts by suggesting process enhancements, participating in problem-solving initiatives.
  • Adhere to safety protocols, clean room procedures, and regulatory guidelines, including Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and ISO standards, to ensure a safe working environment and product quality.
About Cleanroom Awareness and Knowledge Requirements

In this role, you will require comprehensive understanding of cleanroom classifications and respective standards. You will also need to adhere to aseptic techniques and sterile gowning procedures to maintain environmental integrity. Additionally, awareness of contamination sources (e.g., particulates, microbes) and methods to prevent them is essential. Familiarity with chemical handling procedures, including storage, labeling, and disposal within a controlled environment, is also necessary.

About Qualification

To be successful in this role, you will need to have a Bachelor's degree in Biotechnology/Biochemistry or equivalent. A minimum of 2-3 years of experience in IVD or related fields is required, with prior experience in buffer preparation, cleanroom operations being mandatory. Previous experience in manufacturing, automated filling machinery, and the medical device industry is preferred.

About Salary and Benefits

We offer a competitive salary commensurate with experience, ranging from ₹8,00,000 to ₹12,00,000 per annum. Our benefits package includes comprehensive health insurance, paid time off, and opportunities for professional development and advancement within the company. The salary range is based on industry standards and takes into account factors like location, qualifications, and experience.

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