Job Description

A subject matter expert with 5-7 years of experience who will lead microbiology-related activities for the development, manufacturing, and release of blood collection tubes and other IVD products. This role requires extensive knowledge of microbiological techniques, regulatory standards (e.g., FDA, ISO), and quality systems (e.g., cGMP, GLP). The candidate will be responsible for designing and executing validation protocols, troubleshooting contamination issues, and mentoring junior staff.

Key responsibilities:

Microbiological Testing and Analysis:

Design, conduct, and review advanced microbiological testing on raw materials, in-process samples, and finished products, including bioburden, sterility, biocompatibility, and endotoxin testing (LAL assay).

Method Development and Validation:

Lead the development, verification, and validation of new microbiological test methods and procedures in accordance with industry standards.

Environmental Monitoring (EM):

Oversee and manage the environmental monitoring program for cleanrooms and laboratory facilities. This includes developing sampling schedules, analyzing data, and investigating results that exceed limits.

Sterilization Validation:

Serve as a key resource for the validation of sterilization processes for medical devices, particularly blood collection tubes. Prepare and review sterilization protocols and reports.

Investigation and Root Cause Analysis:

Lead and manage microbiological investigations into product failures, out-of-specification (OOS) results, and quality deviations. Propose and implement corrective and preventive actions (CAPAs).

Documentation and Reporting:

Maintain meticulous and accurate laboratory records following Good Documentation Practices (GDP). Prepare and present technical reports, research findings, and investigation summaries for internal and external stakeholders, including regulatory bodies.

Quality and Regulatory Compliance:

Ensure all microbiology lab operations and testing are compliant with cGMP, GLP, FDA, EU, CDSCO regulations, and ISO standards (e.g., ISO 13485). Participate in internal and external audits.

Mentorship and Training:

Provide technical guidance and training to junior microbiologists and laboratory technicians, fostering a culture of scientific excellence and continuous improvement.
Qualifications

Education:

Bachelor's or Master's degree in Microbiology, Biology, Molecular Biology, or a closely related scientific field. A Master's degree is preferred.

Experience:

5-7 years of demonstrated experience as a microbiologist in the medical device or IVD industry, with specific exposure to blood collection products.

Certifications:

Professional certifications in quality systems such as GMP/GLP are a plus.

Skills

Technical skills:

Extensive knowledge of GLP (Good laboratory practice) Extensive knowledge of aseptic techniques, microbial culture, and isolation methods. Proficiency in sterility testing, bioburden analysis, biocompatibility, and endotoxin testing (LAL). Expertise in method validation and sterilization validation protocols for medical devices. Strong understanding of regulatory guidelines, including ISO 13485, and relevant USP/EP requirements. Experience with advanced molecular techniques, such as PCR, for microbial identification and testing. Proficiency with laboratory equipment, including incubators, microscopes, stability chamber, BOD, and automated testing systems.

Soft skills:

Attention to detail:

Meticulous approach to laboratory work, record-keeping, and analysis.

Analytical and problem-solving skills:

Ability to interpret complex data, investigate deviations, and perform root cause analysis.

Communication:

Excellent written and verbal communication skills for preparing reports, presenting findings, and interacting with cross-functional teams.

Leadership and mentorship:

Ability to guide and train junior staff and lead projects effectively.

Organizational skills:

Strong ability to manage multiple tasks, prioritize projects, and meet tight deadlines.

Teamwork:

Capability to collaborate effectively with R&D, Quality Assurance, and Manufacturing teams
Job Type: Full-time

Pay: ₹40,000.00 - ₹50,000.00 per month

Benefits:

Paid time off Provident Fund
Work Location: In person