Director, Process Development- Drug Product

Amgen Technology; Hyderabad; On-site; INR 4,500,000 - 7,500,000; Full time

Job summary

Amgen Technology in Hyderabad, India, seeks a Director of Process Development to build and lead the Drug Product Technologies team, shaping capabilities, operations, and cross-site partnerships for drug product deliverables. You will ensure quality and align with Amgen values, reporting to the Executive Director with dotted lines to DPT leadership.

You will recruit and develop talent, set priorities, and drive digital transformation across DPT workflows, leveraging AI and data analytics to

Qualifications

• Doctorate, 8+ years in drug product biotech.
• Master's degree, 15+ years in drug product biotech.
• Bachelor's degree, 20+ years in drug product biotech.
• 4+ years of managerial or leadership experience.

Responsibilities

• Build and lead the Drug Product Technologies organization at AIN.
• Define roles, operating model, governance, and engagement frameworks with DPT leadership.
• Develop and scale capabilities across docs, regulatory authoring, data analytics, AI tools, automation, in-silico modeling, and process monitoring.
• Champion digital transformation across DPT workflows with cross-functional teams.
• Set strategic priorities, timelines, and execution plans for initiatives.
• Recruit, onboard, coach, and develop talent; foster inclusive culture.
• Plan and manage resources, including budget, contractors, and staff.
• Use metrics and insights to drive continuous improvement and elevate risks.

Skills

People management

Cross-functional leadership

Regulatory knowledge

AI/ML tooling

Data analytics

Agile methodologies

Strategic planning

Stakeholder management

Communication

Budget management

Process improvement

Education

Doctorate degree

Master's degree

Bachelor's degree

Job description

Role overview

In this vital role you will lead a diverse team within our Process Development organization, maintaining accountability for its daily operations with a focus on Drug Product Technologies (DPT). You will build a new team, creating the capabilities, operating model, and cross-site partnerships needed to advance drug product deliverables for Amgen products. You will ensure a high level of quality in the work performed. You will partner with key internal stakeholders to build this new organization, define the required capabilities, and resource it with a team of qualified personnel who have the education, experience, and training needed to perform the work in alignment with Amgen values.

As Director, Process Development, you will report to the Executive Director, Process Development and have a dotted line to DPT leadership, leading a team at AIN that is focused on advancing drug product capabilities and deliverables.

Responsibilities

• Build and lead the Drug Product Technologies organization at AIN, establishing a high-performing team that expands global DPT capabilities and supports delivery across Amgen's product portfolio.
• Establish AIN as an integrated extension of the global DPT organization by defining roles, responsibilities, operating model, governance, and engagement frameworks in partnership with DPT leadership, AIN stakeholders, and global site teams.
• Develop and scale team capabilities across technical documentation, regulatory authoring and support, data analytics, AI-enabled tools, automation, in-silico modeling, and process monitoring.
• Champion digital transformation across DPT workflows by translating scientific, business, and regulatory needs into requirements and partnering with Technology, Data/AI, and functional teams to develop, deploy, and continuously improve digital capabilities.
• Set strategic priorities, project timelines, and execution plans for key initiatives, ensuring timely delivery of goals and alignment with portfolio and organizational objectives.
• Recruit, onboard, coach, and develop talent; build future leaders; manage performance; and foster an inclusive culture of accountability, collaboration, and continuous learning.
• Plan and manage resources, including budget, contractors, and staff, to ensure effective delivery of team priorities and sustained organizational performance.
• Use performance metrics, process insights, and issue trends to drive continuous improvement, resolve barriers, and elevate risks as appropriate.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients.

Basic Qualifications

• Doctorate degree and 8 years of drug product biotech experience
• Master's degree and 15 years of drug product biotech experience
• Bachelor's degree and 20 years of drug product biotech experience
• 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources

Preferred Qualifications

• 14+ years of drug product process development or manufacturing experience in biotech or pharmaceutical industry
• Advanced Degree in Biochemistry, Biochemical Engineering, Chemical Engineering, or related discipline
• Knowledge of cGMP regulations (FDA, EMEA, Health Canada)
• Working knowledge of applicable drug product manufacturing/testing processes (process development, process validation, commercial manufacturing)
• Experience applying automation, artificial intelligence, machine learning, or large language model-enabled tools in a compliant environment
• Experience with regulatory filings
• Knowledge of statistics, data analytics tools and methods
• Knowledge of project management tools and Agile methodologies
• Strong leadership skills with the ability to build new teams and implement new processes
• Demonstrated ability leading and coaching cross-functional teams, consistently deliver on-time, and with high-quality results
• Strong verbal and written communication. Ability to communicate effectively with Senior and Executive Leadership, including communicating level of risk, urgency, or impact to the business
• Ability to operate in an international matrix or team environment with site, functional, and executive leadership
• Ability to flex working hours to maximize interactions with global teams