Production manager

Position: Filter Production- Manager

A career with Ami Polymer is an ongoing journey of discovery: our >1700 people are shaping global healthcare by spearheading the One Health Initiative. For last 40 years we have passionately pursued our mission “ P artnering with Life-Sciences Community through Innovative Polymer Solutions for Affordable Healthcare ”.

Who we are: Ami Polymer Private Limited (APPL) is the market leader in veterinary and human biologicals in India. It manufactures over 150+ products. IIL operates one of the largest plants in the world for veterinary vaccines. APPL has adequate infrastructure and cold chain distribution capability to reach out to various parts of India and world market. This flexibility in logistics has ensured many products of APPL occupy top slots in the market. APPL is a major player in the human vaccine market in India, focusing on the paediatric and rabies vaccine segments. APPL is also a major supplier of paediatric vaccines to India’s large Universal Immunization Programme.  APPL exports a nimal and human vaccines to more than 60 countries. We collaborated with several national and international institutes of repute in vaccines. This has enabled development of top novel products for overall wellbeing.

Ami Polymer was established in 1998. The Kala unit New Greenfield project was operational as 1 st April in the year 2025

Your role: Lead the end-to-end establishment, validation, and continuous improvement of a sterile filter manufacturing facility (pleated filters, capsule filters). The role combines project management, process engineering, quality compliance and validation.

Incumbent of this position will report to Chandan Kumar Sah and have the following responsibility:

1) Manufacturing Line Setup & Project Management

• Lead the complete setup of filter manufacturing lines including pleated and capsule filters.
• Define cleanroom and production layout aligned with ISO cleanroom classifications.
• Coordinate with vendors, contractors, and internal stakeholders.

2) Process Engineering & Documentation

• Design robust and scalable manufacturing processes.
• Prepare and maintain:
  • SOPs
  • Batch records
  • Process flow diagrams
• Support material selection and product design feasibility.

3) Validation & Regulatory Compliance

• Ensure compliance with:
  • GMP requirements
  • ISO 13485 and ISO 9001
  • Regulatory expectations for biopharma single-use components
• Lead validation activities:
  • IQ / OQ / PQ for equipment
  • Cleanroom validation
  • Equipment calibration programs
• Conduct process trials and validation batches.
• Ensure smooth scale-up from development to commercial production.

4) Quality & Testing Support

• Establish quality control checkpoints across production.
• Support and participate in validation studies:
  • Extractables & Leachables
  • Bacterial retention testing
  • Filter integrity testing
• Participate in customer and certification audits.

The above list of duties is not exclusive or exhaustive and the post holder will be required to undertake such tasks as may reasonably be expected within the scope of the post. Job descriptions will be regularly reviewed to ensure they are an accurate representation of the post.

Who you are:

Education

·        M.Sc./ M. Pharm/ M.Tech/ B.Tech ( Biotech / Microbiology / Biochemistry)

·        Advanced degree strongly preferred ( Ph.D)

Experience

·        Minimum of 10+ years of experience at Team leader position in reputed Filtration product handling.

·        Should have good knowledge about Filter manufacturing process.

·        Understanding of polymer materials & membrane technologies

·        Should have Strong leadership and ownership mindset

·        Should have Ability to work in fast-growing manufacturing environment

·        Should be well versed with Process validation & statistical analysis.

Personality Traits

·        Strong people management and collaboration skills.

·        Fluent in both written and spoken English

·        High science/engineering, regulatory and compliance orientation

·        Good communicator, dealing directly and effectively with 10+ teams size.

·        Strong analytical and problem-solving abilities.

·        Structured, organized, and logical in defining workload and delivering projects.

Additional Needs

·        The post holder may be required to travel between sites and on occasion visit based on organizational needs

·        Global mindset and to be willing to engage in conference calls at out-of-office hours and odd hours of working.