Manager, Lab Systems

Amgen; Hyderabad; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

Amgen seeks a seasoned Manufacturing Site Technology Sustainment leader to direct a cross‑functional team delivering 24/7 support for core manufacturing tech. You will ensure uptime, data integrity and regulatory compliance while driving continuous improvement across global sites.

The role emphasizes end‑to‑end tech operations in a highly regulated biotech setting, with collaboration across QA, IT and site operations, and a focus on scalable, compliant processes.

Qualifications

• Experience leading technology operations in a regulated biotech environment.
• Proven track record with lab systems from deployment to maintenance.
• Strong knowledge of GMP, CSV and Annex 11/21 CFR Part 11.

Responsibilities

• Serve as System Owner for lab systems ensuring reliability and GMP compliance.
• Execute configuration changes under formal change control.
• Maintain documentation, validation deliverables and inspection readiness.
• Collaborate with global teams on system improvements and CAPAs.
• Support audits, data integrity assessments and root cause analysis.

Skills

Lab systems management

GMP/regulatory compliance

Scaled Agile (SAFe)

ITIL framework

Change control/process optimization

Cross-functional collaboration

Education

Bachelor's degree in Science/Engineering

Tools

Change control tools

Validation tooling

Job description

About Amgen

Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today.

About Amgen

Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today.

About The Role

Role Description

The role will be part of the Manufacturing Site Technology Sustainment team that provides “follow the sun” support to the technology capabilities deployed at the Manufacturing sites that positively impacts business outcomes. This individual will be responsible for developing and leading a highly talented team that is built for delivering best in class operational support.

The ideal candidate will have a proven track record of leadership in technology-driven environments for the Manufacturing Technology area and has a passion for fostering continuous improvement and service excellence in the biotechnology industry. Additionally, collaboration with cross-functional and global teams is required to ensure seamless integration and operational excellence. The ideal candidate will have a strong background in end to end technology operations support in a highly regulated environment and a Scaled Agile practitioner, coupled with leadership and transformation experience. This role plays a critical role in maintaining manufacturing uptime, product quality, and regulatory compliance while driving operational excellence and continuous improvement.

Roles & Responsibilities

• Serve as System Owner for a number of different Lab systems, ensuring reliability, data integrity, and continuous GMP compliance.
• Execute configuration and system changes under formal change control to optimize performance while maintaining validated state.
• Ensure system documentation, configuration records, and validation deliverables remain inspection-ready at all times.
• Ancillary support to internal and external audits, inspections, and data integrity assessments.
• Maintain alignment with global computer systems validation (CSV) and Annex 11 / 21 CFR Part 11 requirements.
• Provide complex functional support to RunOps team
• Facilitate escalation and resolution of complex system issues with global product owner and/or application vendor as needed
• In collaboration with business performance, OE/CI Analyst, site PM, scrum master, to effectively schedule, communicate and implement changes to sites
• Provide SME inputs to support root cause analysis and implement corrective/preventive actions (CAPA) to ensure system reliability.
• Monitor system performance and proactively identify opportunities to improve system efficiency and user experience.

Basic Qualifications and Experience

• Any degree with 8 - 13 years of experience in Business, Engineering, IT or related field

Functional Skills

Must-Have Skills (Not more than 3 to 4)

• The lab system manager should have hands on experience working with computer systems from inception to deployment to maintenance. A general to good understanding of Quality processes, Laboratory, benchtop, and manufacturing systems.
• General IT architecture and hardware knowledge and general understanding of project management, customer service, and conflict resolution skills.
• Must be flexible and able to manage multiple activities and priorities with minimal direction in a rapidly changing and demanding environment.
• Exceptional collaboration, communication and interpersonal skills to effectively manage stakeholder relationships and build new partnerships.
• Experience in applying technology best practice methodologies: Scaled Agile (SAFe), ITIL, etc.
• Demonstrate deep understanding of biopharmaceutical industry, GMP regulated environment

Good-to-Have Skills

• Experience in a leadership role within a pharmaceutical or technology organization
• Extensive experience in the software development lifecycle.
• Experience using and adoption of Scaled Agile Framework (SAFe)
• Strong analytic/critical-thinking and decision-making abilities.
• Ability to work effectively in a fast-paced, dynamic environment.
• Established business partnerships and IS governance practices involving senior business stakeholders
• Broad working knowledge of key IS domains and layers

Professional Certifications

• ITIL (preferred)
• Scaled Agile Framework (SAFe) for Teams

Soft Skills

• Excellent leadership and team management skills.
• Strong transformation and change management experience.
• Exceptional collaboration and communication skills.
• High degree of initiative and self-motivation.
• Ability to manage multiple priorities successfully.
• Team-oriented with a focus on achieving team goals.
• Strong presentation and public speaking skills.
• Excellent analytical and troubleshooting skills
• Strong verbal and written communication skills
• Ability to work effectively with global, virtual teams

Shift Information

This position requires you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements.

EQUAL OPPORTUNITY STATEMENT

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.