Director, Process Development - Attribute Sciences

Amgen Technology; Hyderabad; Hybrid; INR 350,000 - 700,000; Full time

Job summary

Amgen is seeking a senior leader to head Attribute Sciences at AIN, guiding analytics, method development, and lifecycle management for Amgen products. You will build and direct a multi-disciplinary team, collaborate with global partners, and drive regulatory-compliant data strategies.

The role requires substantial experience in analytical science, manufacturing, and leadership, with a track record of delivering high-quality results across complex programs in a matrix environment.

Qualifications

• Doctorate with 8 years in analytical sciences, process development, manufacturing, or biotechnology.
• Master's with 15 years in analytical sciences, process development, manufacturing, or biotechnology.
• Bachelor's with 20 years in analytical sciences, process development, manufacturing, or biotechnology and 4 years in management.

Responsibilities

• Lead a team at AIN focused on Attribute Sciences deliverables for Amgen products.
• Build and lead Attribute Sciences team across method monitoring, lifecycle management, and automation.
• Define roles, hire, and implement new processes with partners.
• Establish operating model, governance, and engagement framework.
• Drive knowledge sharing and global handoffs across Amgen sites.
• Partner with cross-functional teams to improve data flows and analytical ways of working.
• Manage the Attribute Sciences team to ensure timely completion with quality and compliance.
• Set project timelines and translate needs into team capabilities and plans.

Skills

Analytical sciences

Process development

Manufacturing

Biotechnology

Regulatory knowledge

Automation/AI/ML in enterprise

Data analytics

Project management

Agile methodologies

Leadership

Education

Doctorate in Analytical Sciences

Master's in a relevant field

Bachelor's in a relevant field

Job description

Job Summary

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

As a member of the Amgen team, youll 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.

Responsibilities

• 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 elevate 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 OR
• Masters degree and 15 years of analytical sciences, process development, manufacturing, or biotechnology experience OR
• Bachelors 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