Enzene is a technology driven company based in Pune, India. We strive to harness disruptive innovation to enhance global health. Our aim is to provide, affordable, quality medicine for aiding lives with debilitating conditions. Enzene has invested in world class R&D infrastructure which allow access to technologies of the future. Enzene has end to end development platform from our own propriety CHO duos cell lines, to high throughput upstream and downstream platforms, comprehensive drug product development capabilities backed by state of the art advanced analytical technologies supports speedy development of pre-clinical and clinical drug candidates.
Post : Senior Manager - QC Analytical
Seeking a highly skilled and experienced Quality Control Analytical Laboratory Senior Manager to lead our QC team in a biologics manufacturing facility. The ideal candidate will have extensive experience with Chromatography based methods, plate-based methods, and managing large teams. This role is critical in ensuring the highest standards of quality and compliance in our laboratory operations.
Job Description
Key Responsibilities
1. Leadership and Management
• Lead, mentor, and manage a team of QC analysts and technicians.
• Develop and implement training programs to enhance team skills and knowledge.
• Foster a culture of continuous improvement and teamwork.
2. Quality Control Operations :
• Oversee daily QC laboratory operations, ensuring compliance with cGMP, FDA, and other regulatory requirements.
• Validate, and implement analytical methods, including HPLC and plate-based assays as well as General assays.
• 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.
• Analyse data and generate reports for senior management and regulatory submissions.
• Implement and manage laboratory information management systems (LIMS).
4. Compliance and Audits
• Conduct regular internal audits to ensure compliance with quality standards.
• Prepare for and host external audits and inspections by regulatory agencies.
• Develop and implement corrective and preventive actions (CAPAs) as needed.
Candidate Profile
Qualifications and Requirements
• Master’s degree or advanced degree in Chemistry, Biology, or a related field.
• Extensive experience with HPLC and plate-based methods.
• Strong knowledge of cGMP, FDA, and other regulatory requirements.
• Excellent leadership, communication, and interpersonal skills.
• Proven ability to manage and develop large teams.
• Strong analytical and problem-solving skills.
• Proficiency with laboratory information management systems (LIMS).
Preferred Qualifications
• Experience in a biologics manufacturing environment.
• Knowledge of additional analytical techniques such as ELISA, PCR, and cell-based assays.
• A strong knowledge of GMP, GLP, GDP, and other relevant quality standards and regulations, such as FDA, EMA, ICH, etc.
• A demonstrated ability to plan, execute, and oversee complex quality projects and initiatives, ensuring timely and successful completion
• A high level of analytical, problem-solving, and decision-making skills, with a data-driven and risk-based approach
• A customer-oriented and results-driven mindset, with a focus on quality excellence and customer satisfaction
• A strong leadership and interpersonal skills, with the ability to influence, motivate, and inspire others
• Excellent oral and written communication skills, with the ability to communicate effectively with internal and external stakeholders at all levels
Experience : 15 years of experience in a QC laboratory, with at least 5 years in a managerial role.
Experienced in managing QC Analytical Laboratory
Additional Information
Experience : 5 years
Qualification : Master’s degree or advanced degree
Location : Pune, Maharashtra
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Quality Control
End Date : 28th February 2025
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