Director, Process Development- Drug Product

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

Job summary

Amgen Inc. in Hyderabad, India seeks a Director, Process Development to lead Drug Product Technologies and scale a new DPT-focused team. You will partner with global stakeholders to define capabilities, governance, and delivery across Amgen’s portfolio.

You will recruit, coach, and develop talent, manage resources, and drive digital transformation while ensuring regulatory readiness and timely, high-quality drug product deliverables.

Qualifications

• Doctorate degree and 8 years of drug product biotech experience.
• Master's degree and 15 years of drug product biotech experience with 4 years of managerial experience.
• Bachelor's degree and 20 years of drug product biotech experience with managerial experience directing teams and resources.

Responsibilities

• Lead a diverse Process Development team focusing on Drug Product Technologies.
• Build capabilities, operating model, governance, and cross-site partnerships.
• Recruit, onboard, coach, and develop talent; manage performance.
• Plan and manage resources, including budget, contractors, and staff.
• Drive continuous improvement using performance metrics and issue trends.

Skills

Leadership

Team building

Communication

Agile

Data analytics

Automation

AI/ML

Regulatory filings

Project management

Education

PhD in Biotech/related field

M.S. in Biochemical/Engineering

B.E./B.Tech in related field

Tools

AI tooling

Automation tooling

Regulatory documentation software

Job description

Career Category Process Development Job Description

Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

What you will do

Let’s do this. Let’s change the world. 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 Report dotted line to DPT leadership, leading a team at AIN that is focused on advancing drug product capabilities and deliverables. 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 escalation 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 AND 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.

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided 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. Please contact us to request accommodation.

About Amgen

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakthrough potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.