Director, Process Development - Drug Substance

Amgen Inc. (IR); Hyderabad; On-site; INR 4,000,000 - 7,500,000; Full time

Job summary

Amgen is seeking a Director, Process Development in Hyderabad to lead the Drug Substance Technologies (DST) team at AIN, creating capabilities, governance, and a scalable operating model for drug substance deliverables. You will partner with Amgen sites globally to define roles, resource the team, and drive continuous improvement while aligning with Amgen values.

You will recruit, develop, and coach the team, manage budgets, and implement digital tools to enhance data analytics and regulatory

Qualifications

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

Responsibilities

• Lead a diverse team within our Process Development organization, focusing on Drug Substance Technologies (DST)
• 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
• Define roles and responsibilities, hire and build new teams and implement new processes
• Establish and drive knowledge sharing, learning and networking across DST teams
• Set project timelines and priorities for key initiatives and team activities
• Translate business, technical, and regulatory needs into team capabilities, priorities, and execution plans

Skills

Leadership

Agile methodologies

Communication

Data analytics

Automation/AI tools

Cross-functional teamwork

Education

Doctorate in Biotech/related

Master’s in biotech/related

Bachelor’s in biotech/related

Advanced degree in Biochemistry/Engineering

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 on-going 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
• Master’s degree and 15 years of drug substance biotech experience
• Bachelor’s degree and 20 years of drug substance 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 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.

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. . 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 breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen