Enzene - QC Analytical Manager - 1130 Works

About Our Client - Enzene
Enzene Inc. is an emerging Contract Development and Manufacturing Organization (CDMO) with a strong operational footprint in India. We are a subsidiary of Enzene Biosciences, a leading biotechnology company. Our mission is to provide high-quality biologics manufacturing services to our clients, contributing to the advancement of the pharmaceutical industry.

Website: www.enzene.com

Position Overview
We are seeking a Quality Control Analytical Manager to oversee the quality control processes within our laboratory, ensuring that all analytical procedures meet regulatory standards and produce accurate results.

Key Responsibilities

• Quality Control Oversight: Manage and oversee the quality control activities in the laboratory, ensuring compliance with regulatory standards.
• Problem Solving: Investigate and resolve any quality control issues or OOS or deviations, implementing corrective actions as needed.
• Method Development and Validation: Develop, validate, and implement analytical methods for testing raw materials, intermediates, and finished products.
• Team Leadership: Supervise and train QC analysts and chemists, fostering a culture of continuous improvement.
• Compliance: Ensure all laboratory activities comply with GMP and regulatory requirements. Oversee CAPAs, deviations, and change controls within Analytical group.
• Data Analysis and Reporting: Review and approve analytical data and reports, ensuring accuracy and reliability. Familiarity with LIMS for data tracking and management.
• Equipment Management: Ensure proper maintenance, calibration, and operation of analytical instruments and equipment.
• Documentation: Author Procedures, Protocols and Reports, maintain accurate and detailed records of all QC activities, including test results and equipment logs.

Qualifications

• Education: Bachelor’s Degree in relevant fields such as Chemistry, Biochemistry, Biotechnology or a related discipline. Advanced degrees preferred.
• Experience: 7-10 years of leadership experience in analytical method development, validation, and transfer in the biopharmaceutical industry. Regulatory compliance, particularly in OOS results, also required.
• Skills: Proficiency in HPLC, UPLC, Gas Chromatography, Atomic Absorption, Mass Spectrophotometry, pH, CCIT, Water Testing (TOC), Karl Fischer, CIEF, CE-SDS, ELISA and other analytical methods.

Why Join Enzene?
At Enzene, we foster a collaborative and innovative environment where science and business intersect. Our team is dedicated to pushing the boundaries of biosimilar manufacturing, and we are constantly striving to improve processes and patient outcomes. Joining Enzene means being part of a company that values integrity, innovation, and collaboration in pursuit of scientific excellence.

We offer an environment of growth, learning, and opportunity in a sector that is driving change in healthcare.

Equal Opportunity Employer
Enzene is an equal opportunity employer, committed to fostering a diverse and inclusive work environment where all employees can thrive.