Director, Process Development - Drug Substance

amgen; Hyderabad; On-site; INR 5,000,000 - 7,500,000; Full time

Job summary

Amgen is seeking a Director, Process Development to lead a new Drug Substance Technologies team at the AIN site. You will oversee a diverse group focused on advancing drug substance deliverables, governance, and cross-site partnerships, while building capabilities in documentation, analytics, and automation.

The role demands strategic planning and exceptional leadership across global teams. You will report to DST leadership, manage timelines and budgets, and drive continuous improvement.

Qualifications

• Doctorate or Master’s or Bachelor’s with long-term biotech/substance experience and leadership experience.
• Senior leadership experience required: managing teams, projects, and resources.
• Background in biotech drug substance development with cGMP knowledge preferred.

Responsibilities

• Lead a diverse DST team at the AIN site to advance drug substance deliverables.
• Define roles, hire, and build new teams; implement new processes across DST.
• Develop capabilities across documentation, data analytics, and automation tools.
• Establish strong communication with existing DST teams to share knowledge.

Skills

Leadership

Cross-functional teams

Project management

Data analytics

Education

Doctorate in Biotech

Master’s in Biochemical/Engineering

Bachelor’s in related field

Tools

Process development tools

Automation tools

Statistical tools

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 youwill do

Let’s do this. Let’s change the world. In this vital role you will lead adiverse team within our Process Development organization,maintaining accountability for its daily operationswith a focus on Drug Substance Technologies (DST). You willbuild a new team, creating the capabilities, operating model, and cross-site partnerships needed to advance drug substance deliverables for Amgen products. You will ensure a high level of quality in the work performed. You will partner with key internal stakeholders tobuild this new organization, define the required capabilities, and resource it with ateam of qualified personnel who have the education, experience, and training needed to perform the work inalignment with Amgen values.

AsDirector,Process Development,you willreport to the Executive Director,Process Developmentand:

• Report dotted line toDST leadership, leading a teamat AIN thatis focused on advancingdrug substance deliverables for all Amgen products

• Work with functional partnerswithin AIN as well as other Amgen sites and teamsto define roles and responsibilities, hire and build new teamsand implement new processes

• Build and lead a new DST team at AIN with capabilities across technical documentation, regulatory authoring and support, data analytics, automation/digital tools, and process monitoring

• Creation of strong communication channels with existing DST teamsacross the Amgen sitesto establish and driveknowledge sharing, learning and networking

• Work with cross-functional teams to establish and improve digital tools as voice of customer

• Manage the team for Drug Substance Technologiesat AIN to ensure timely completion of goals and objectives

• Set project timelines and priorities for key initiatives and/or team activities

• Lead and developtheteam, providing staff member supervision and on-going coaching

• Strategically plan, analyze, and manage resources to include budget, contractors, staff, etc.

• Actupon performance metrics and process issues, implementing actions to drive continuous improvement and escalation to management if needed

• Partner to establish the operating model, governance, and engagement framework for the AIN DST team in partnership with DST leadership and AIN site stakeholders

• Translate business, technical, and regulatory needs into team capabilities, priorities, and execution plans

What we expectofyou

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

Basic Qualifications:

Doctorate degree and 8 years ofdrug substance biotechexperienceOR

Master’s degree and 15 years ofdrug substance biotechexperience OR

Bachelor’s degree and 20 years ofdrug substance biotechexperienceAND

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 ofdrug substance process development ormanufacturing 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 substance 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 enterprise environment.

• Knowledge ofstatistics,data analyticstools and methods

• Knowledge ofproject management toolsand Agile methodologies

• Strong leadership skillswiththe ability tobuild new teams and implement new processes

• Demonstrated ability leading and coachingcross-functional teams, consistentlydeliveron-time, and with high-quality results

• Strong verbal and written communication. Ability to communicate effectively with Senior and Executive Leadership, includingcommunicatinglevel of risk, urgency, or impact to the business

• Ability to operate in an internationalmatrix or team environment with site, functional, and executive leadership

• Ability to flex working hours to maximize interactions with global teams

What you can expectofus

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.

Objects in your future are closer than they appear. Join us.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

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.