Great opportunity for QC Analytical Senior Manager at Enzene- Apply before 28th February 2025

Senior Manager – QC Analytical
Enzene Biosciences, Pune, India

About Enzene Biosciences

Enzene Biosciences is a technology-driven biopharmaceutical company based in Pune, India. We are dedicated to harnessing innovation to enhance global health by providing high-quality, affordable medicines for individuals with debilitating conditions. Our world-class R&D infrastructure and cutting-edge technologies enable us to accelerate the development of pre-clinical and clinical drug candidates. Enzene’s end-to-end development platform, encompassing proprietary CHO Duos cell lines, advanced upstream and downstream processing, and state-of-the-art analytical technologies, ensures speed and efficiency in biologics manufacturing.

Job Title: Senior Manager – QC Analytical

Job Location: Pune, Maharashtra
Industry: Pharmaceuticals / Biologics / Healthcare
Functional Area: Quality Control
Experience Required: Minimum 15 years in a QC laboratory, with at least 5 years in a managerial role
Qualification: Master’s degree or advanced degree in Chemistry, Biology, or a related field
Application Deadline: 28th February 2025

Job Summary

We are seeking an experienced and highly skilled Senior Manager – QC Analytical to lead our Quality Control (QC) team in a biologics manufacturing facility. The ideal candidate should possess extensive expertise in chromatography-based methods, plate-based assays, and team management. This role is crucial in maintaining the highest standards of quality, compliance, and operational efficiency within our laboratory environment.

Key Responsibilities

1. Leadership and Team Management

• Lead, mentor, and develop a team of QC analysts and technicians.
• Design and implement training programs to enhance team skills and knowledge.
• Foster a culture of continuous improvement and teamwork within the QC department.

2. Quality Control Operations

• Oversee daily laboratory operations, ensuring compliance with cGMP, FDA, and other regulatory requirements.
• Validate and implement analytical methods, including HPLC, plate-based assays, and general quality tests.
• Ensure accurate and timely testing of raw materials, packaging materials, in-process samples, and finished products.

3. Data Management and Reporting

• Maintain accurate and complete records of all QC activities.
• Analyze data and generate reports for senior management and regulatory submissions.
• Implement and manage Laboratory Information Management Systems (LIMS) for efficient data tracking.

4. Compliance and Audits

• Conduct internal audits to ensure adherence to quality standards.
• Prepare for and facilitate external audits and inspections by regulatory agencies.
• Develop and implement Corrective and Preventive Actions (CAPAs) as required.

Candidate Profile

Qualifications & Skills

• Master’s degree or higher in Chemistry, Biology, or a related field.
• Extensive experience with HPLC and plate-based methods.
• Strong knowledge of cGMP, FDA, and regulatory compliance standards.
• Excellent leadership, communication, and team management skills.
• Proficiency in data analysis and laboratory information systems (LIMS).

Preferred Qualifications

• Experience in a biologics manufacturing environment.
• Knowledge of advanced analytical techniques such as ELISA, PCR, and cell-based assays.
• Strong understanding of GMP, GLP, GDP, and regulatory frameworks (FDA, EMA, ICH).
• Demonstrated ability to manage complex quality projects efficiently.
• Analytical mindset with strong problem-solving and decision-making skills.
• Ability to collaborate effectively with internal and external stakeholders.

Why Join Enzene?

• Work with cutting-edge technologies in a dynamic and innovative environment.
• Opportunity to contribute to global healthcare solutions.
• Competitive compensation and career growth opportunities.
• Collaborative and research-driven work culture.

Apply Now!
If you are an experienced QC professional looking to make a significant impact in biologics manufacturing, we encourage you to apply before 28th February 2025.

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