Manager – MS&T (Manufacturing Science & Technology)
Location: Hyderabad, India
Category: Operations / Production & Manufacturing
Employment Type: Full-Time, Regular
Experience Required: Minimum 12 years in MS&T, Quality Assurance, or Biologics Manufacturing
About Novartis
Novartis is a global healthcare leader committed to reimagining medicine to improve and extend people’s lives. With a focus on innovation, quality, and patient-centric solutions, Novartis combines scientific expertise with a collaborative culture to deliver breakthrough therapies in biologics, small molecules, and advanced therapies.
Role Overview
The Manager – MS&T will serve as a subject matter expert in deviation management, investigations, and quality operations within Novartis’ Radio Ligand Therapy (RLT) platform. This role ensures robust deviation handling, root cause analysis (RCA), and corrective/preventive action (CAPA) implementation across production sites. The manager will coordinate with cross-functional teams to drive quality compliance, process improvements, and inspection readiness.
Key Responsibilities
Manage deviation, complaint, and out-of-specification (OOX) investigations using the 1QEM system, adhering to Novartis’ quality management framework.
Conduct root cause analyses using tools such as Fishbone diagrams, 5 Whys, and process mapping.
Collaborate with cross-functional teams, including Production, QA, Engineering, and site leadership, ensuring effective communication and timely resolution of deviations.
Facilitate Deviation and RCA review meetings, translating findings into actionable documentation.
Track and report metrics related to change control, CAPA, effectiveness checks (EC), and compliance.
Support quality management system (QMS) actions, including risk assessments, trend reporting, and continuous process improvement initiatives.
Ensure inspection readiness for regulatory audits and Health Authority (HA) inspections.
Develop, review, and maintain GxP documentation, including SOPs, working procedures, and deviation reports.
Provide technical and scientific expertise to ensure compliance with cGMP, SOPs, HSE, and NOSSCE standards.
Support regulatory filings and post-approval changes, ensuring alignment with product quality standards and internal quality guidelines.
Required Qualifications
Bachelor’s degree in Pharmacy, Pharmaceutical Technology, Chemical Engineering, Biotechnology, Biomedical Engineering, or related science field. Advanced degrees (M.Tech, M.Sc./M.S.) preferred.
12+ years of experience in MS&T, Quality Assurance, Regulatory, or Biologics Manufacturing.
Minimum 5 years of experience in MS&T or Manufacturing operations.
Expertise in deviation handling, RCA, CAPA, risk assessment, and change control management.
Familiarity with regulatory requirements, product filings, GxP compliance, and cGMP standards.
Experience in data analysis and statistical evaluation using tools such as Minitab or Statistica.
Strong communication, presentation, and interpersonal skills with ability to collaborate cross-functionally.
Preferred Skills
Knowledge of continuous process improvement and technology transfer processes.
Experience in drug substance manufacturing, process design, and process control.
Ability to lead gap assessments, risk analysis, and quality audits.
Proven project management skills and ability to meet KPIs effectively.
Why Join Novartis
At Novartis, employees are part of a mission-driven, innovative organization that values collaboration, inclusion, and personal growth. Benefits include:
Comprehensive health and wellness programs including medical, dental, and vision coverage.
Competitive retirement plans and 401(k) contributions.
Paid time off, including holidays and flexible leave options.
Opportunities for career development, training, and skill enhancement.
Inclusive and diverse workplace culture committed to employee well-being and growth.
Novartis is an Equal Opportunity Employer, committed to diversity, equity, and inclusion. All qualified candidates will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, national origin, disability, or veteran status.
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