Senior Production Executive Full Time NEW

Astam Diagnostics

Position

Senior Production Executive

Department

Manufacturing / R&D

Location

Bhiwadi, Rajasthan

Joining

Immediate

Join us in building world-class rapid diagnostic solutions

ABOUT ASATAM DIAGNOSTICS

• About Astam Diagnostics

Astam Diagnostics is a dynamic and fast-growing in-vitro diagnostics (IVD) company committed to developing high-quality, affordable diagnostic solutions. Our product portfolio spans Rapid Diagnostic Tests (RDTs), ELISA kits, and Urine Test Strips serving markets across healthcare, clinical research, and point-of-care diagnostics. We are looking for a hands-on, technically proficient Production Executive to drive our manufacturing operations forward.

ABOUT ASTAM DIAGNOSTICS

• Overview

ROLE OVERVIEW

The Production Executive will be responsible for end-to-end manufacturing of lateral flow-based rapid tests, ELISA kits, and urine test strips. The ideal candidate is a skilled lab professional with deep expertise in immunoassay production, conjugation chemistry, and quality-compliant manufacturing. This is a highly technical, hands-on role requiring immediate availability.

• Key Responsibility

KEY RESPONSIBILITIES

Rapid Diagnostic Test (RDT) Production

•     Manufacture lateral flow-based rapid diagnostic test strips (e.g., antigen, antibody, and combo tests) from raw material to finished product

•     Perform nitrocellulose membrane preparation, sample pad treatment, and conjugate pad processing

•     Carry out test assembly, housing, and packaging operations in compliance with SOPs

•     Optimize and troubleshoot RDT sensitivity, specificity, and line intensity

ELISA Kit Production

•     Manufacture ELISA kits including plate coating, blocking, washing, and conjugate preparation steps

•     Prepare and standardize antibody-enzyme conjugates (HRP, AP) and calibrators/controls

•     Conduct in-process quality checks (OD validation, reproducibility, cut-off validation)

•     Manage batch documentation and ensure compliance with ISO 13485 / CE-IVD standards

Urine Test Strip Production

•     Prepare and dispense reagent formulations onto test strips using automated or semi-automated dispensing equipment

•     Perform drying, cutting, and assembly of urine dipstick strips

•     Execute quality testing against reference standards for parameters such as glucose, protein, pH, ketones, nitrites, etc.

•     Calibrate and maintain production equipment and log maintenance records

Conjugation & Biochemistry

•     Perform colloidal gold synthesis and gold nanoparticle conjugation with antibodies/antigens

•     Execute protein conjugation techniques including NHS-ester, EDC, and streptavidin-biotin chemistry

•     Characterize conjugates using UV-Vis spectrophotometry, OD readings, and functional assays

•     Maintain conjugate stability studies and shelf-life data

Quality, Documentation & Compliance

•     Maintain batch records, production logs, and deviation reports in accordance with GMP/QMS requirements

•     Participate in internal audits and support regulatory documentation activities

•     Monitor raw material inventory, initiate procurement requests, and ensure uninterrupted supply

•     Train and guide junior lab staff or production assistants as required

• Required Qualification

REQUIRED QUALIFICATIONS

•     B.Sc. / M.Sc. in Biochemistry, Microbiology, Biotechnology, Life Sciences, or a related discipline

•     Minimum 3–4 years of hands-on experience in an IVD manufacturing environment

•     Proven experience in the production of at least two of: Rapid Tests, ELISA Kits, or Urine Test Strips

•     Demonstrated expertise in colloidal gold conjugation and/or enzyme conjugation techniques

•     Familiarity with ISO 13485, GMP, and IVD regulatory requirements

•     Proficiency in pipetting, spectrophotometry, and membrane-based assay techniques

• Preferred Skills

PREFERRED SKILLS & COMPETENCIES

•     Experience with automated dispensing or lamination equipment for LFA/strip production

•     Knowledge of CE-IVD, CDSCO, or WHO-PQ documentation requirements

•     Strong analytical mindset with the ability to troubleshoot production failures

•     Excellent attention to detail and commitment to product quality and patient safety

•     Ability to work in a fast-paced startup environment and manage multiple SKUs simultaneously

•     Good documentation skills — comfortable with ERP/LIMS or manual batch record systems

WHAT WE OFFER

💼  Competitive Compensation

Market-aligned CTC with performance incentives

🚀  Growth Opportunity

Be part of a growing IVD company with rapid career advancement

🔬  State-of-the-Art Lab

Access to modern production equipment and R&D infrastructure

🌍  Meaningful Work

Contribute to affordable diagnostics reaching underserved markets

HOW TO APPLY

If you have the skills and passion to build life-saving diagnostics, we want to hear from you.

Send your resume and a brief cover letter to: hr@astamdiagnostics.com

Subject Line: Application – Production Executive | [Your Name]

Experience Required: 3–4 Years minimum in IVD / Diagnostics Manufacturing

Availability: Immediate joiners ONLY will be considered, 10-15 days

⚠  Only shortlisted candidates will be contacted. Applications without relevant IVD manufacturing experience will not be processed.