Director, Process Development - Drug Substance

Biopharma Careers; Hyderabad; On-site; INR 4,000,000 - 8,000,000; Full time

Job summary

Amgen is seeking a Director of Process Development to lead a new DST team, delivering drug substance capabilities across multiple sites. The role emphasizes building teams, defining processes, and ensuring high-quality output in line with Amgen values.

The candidate should have extensive biotech drug substance experience, advanced degrees, and a track record of cross-functional leadership in a global setting. A strong emphasis on regulatory and data-driven improvements is expected.

Qualifications

• Doctorate with 8+ years biotech drug substance experience; or Master’s 15+ years; or Bachelor’s 20+ years.
• 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing resources.
• 14+ years of drug substance process development or manufacturing experience in biotech/pharma.
• Advanced Degree in Biochemistry, Biochemical Engineering, Chemical Engineering, or related discipline.

Responsibilities

• Lead a diverse Process Development team focused on Drug Substance Technologies (DST).
• Define roles, hire and build new teams, and implement new processes.
• Build and lead a new DST team with capabilities across documentation, regulatory support, data analytics, automation, and process monitoring.
• Establish strong communication with DST teams across Amgen sites to enable knowledge sharing and collaboration.
• Translate business, technical, and regulatory needs into team capabilities and execution plans.

Skills

Leadership

Team building

Project management

Biotech industry experience

Regulatory knowledge

Education

Doctorate degree

Master's degree

Bachelor's degree

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 Substance Technologies (DST). You will build 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 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 DST leadership, leading a team at AIN that is focused on advancing drug substance deliverables for all Amgen products
• Work with functional partners within AIN as well as other Amgen sites and teams to define roles and responsibilities, hire and build new teams and 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 teams across the Amgen sites to establish and drive knowledge 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 Technologies at AIN to ensure timely completion of goals and objectives
• Set project timelines and priorities for key initiatives and/or team activities
• Lead and develop the team, providing staff member supervision and ongoing coaching
• Strategically plan, analyze, and manage resources to include budget, contractors, staff, etc.
• Act upon 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 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 substance biotech experience OR
• Master's degree and 15 years of drug substance biotech experience OR
• Bachelor's degree and 20 years of drug substance 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 substance 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 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 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.

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

careers.amgen.com

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 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.