Director, Process Development - Attribute Sciences

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

Job summary

Amgen Hyderabad seeks a senior leader in Attribute Sciences to build and guide a team focused on method monitoring, lifecycle management, transfer, regulatory and data analytics for Amgen products.

You will establish governance, partner with cross-functional teams, drive digital tooling and analytics, and manage resources, coaching, and timely delivery of high-quality scientific work. This role demands strong leadership and global collaboration.

Qualifications

• Doctorate degree and 8 years of analytical sciences, process development, manufacturing, or biotechnology experience.
• Master’s degree and 15 years of analytical sciences, process development, manufacturing, or biotechnology experience.
• Bachelor’s degree and 20 years of analytical sciences, process development, manufacturing, or biotechnology experience AND 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources

Responsibilities

• Lead a team at AIN advancing attribute sciences deliverables for Amgen products.
• Build and lead an Attribute Sciences team across method monitoring, transfer, data analytics, and automation/digital tools.
• Establish operating model, governance, and engagement framework for the AIN Attribute Sciences team in partnership with leadership and site stakeholders.
• Create strong communication channels with Attribute Sciences teams across Amgen sites to enable knowledge sharing and global handoffs.
• Partner with cross-functional teams to establish and improve digital tools, data flows, and analytical ways of working.

Skills

Analytical sciences

Process development

Manufacturing

Biotechnology

Leadership

Project management

Communication

Education

Doctorate degree in analytical sciences/biotechnology

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

• Report dotted line to Attribute Sciences leadership, leading a team at AIN focused on advancing Attribute Sciences deliverables for all Amgen products
• Build and lead an Attribute Sciences team at AIN with capabilities across method monitoring and lifecycle management, method transfer, regulatory and technical authoring, data analytics, and automation/digital tools
• 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
• Establish the operating model, governance, and engagement framework for the AIN Attribute Sciences team in partnership with Attribute Sciences leadership and AIN site stakeholders
• Create strong communication channels with existing Attribute Sciences teams across Amgen sites to establish and drive knowledge sharing, learning, networking, and effective global handoffs
• Partner with cross-functional teams to establish and improve digital tools, data flows, and analytical ways of working as the voice of customer
• Manage the Attribute Sciences team at AIN to ensure timely completion of goals and objectives with appropriate scientific rigor, quality, compliance, and customer focus
• Set project timelines and priorities for key initiatives and team activities; translate business, technical, and regulatory needs into team capabilities, priorities, and execution plans
• Lead and develop the team, providing staff member supervision, ongoing coaching, and structured capability development
• Strategically plan, analyze, and manage resources, including budget, contractors, staff, and capacity
• Act upon performance metrics, method health trends, and process issues; implement actions that drive continuous improvement and escal material risks to management as needed

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 analytical sciences, process development, manufacturing, or biotechnology experience
• Master’s degree and 15 years of analytical sciences, process development, manufacturing, or biotechnology experience
• Bachelor’s degree and 20 years of analytical sciences, process development, manufacturing, or biotechnology 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 analytical development, attribute sciences, process development, quality control, or commercial analytical support experience in the biotechnology or pharmaceutical industry
• Advanced degree in Analytical Chemistry, Biochemistry, Biotechnology, Chemical Engineering, Pharmaceutical Sciences, or related discipline
• Expertise in analytical method development, qualification/validation, transfer, troubleshooting, lifecycle management, and product-attribute control strategies for biologics and/or small molecules
• Knowledge of cGMP regulations and expectations (FDA, EMA, Health Canada) and relevant analytical guidance, including ICH Q2 and ICH Q14 principles
• Working knowledge of analytical technologies and data interpretation applicable to characterization, release, stability, comparability, and process monitoring
• 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, including use of performance metrics and trend analysis to support analytical method health
• Knowledge of project management tools and Agile methodologies
• Strong leadership skills with the ability to build teams, establish new capabilities, and implement effective processes
• Demonstrated ability to lead and coach cross-functional teams, consistently deliver on time, and produce high‑quality results
• Strong verbal and written communication, including the ability to communicate level of risk, urgency, or business impact effectively to senior and executive leadership
• 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

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.

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.

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