Director, Process Development - Drug Product

HYDERABAD (IN)ONSITEPOSTED: 9/23/2026
PHARMAFull-time
HIRING ORGANIZATIONAMGENBiotechnology / Pharmaceuticals
Amgen

ROLE OVERVIEW

Lead the establishment and growth of Amgen's Drug Product Technologies organization in Hyderabad, building a high-performing team and operating model while expanding global drug product process-development capabilities through technical, digital and cross-functional innovation.

ROLE DEFINITION & RESPONSIBILITIES

  • Build and lead the Drug Product Technologies organization at AIN
  • Establish roles, responsibilities, governance, operating model and engagement frameworks with global DPT leadership and site stakeholders
  • Develop capabilities in technical documentation, regulatory authoring, data analytics, AI-enabled tools, automation, in-silico modeling and process monitoring
  • Lead digital transformation by translating scientific, business and regulatory needs into technology requirements
  • Set strategic priorities, timelines and execution plans aligned with portfolio objectives
  • Recruit, onboard, coach and develop talent while building future leaders and an inclusive culture
  • Plan and manage budgets, contractors, staffing and other resources
  • Use performance metrics, process insights and issue trends to drive continuous improvement and escalate risks
  • Build cross-site partnerships and integrate the Hyderabad organization with the global DPT network
Reporting Hierarchy: Reports to the Executive Director, Process Development and has a dotted-line reporting relationship to Drug Product Technologies leadership; leads a new Drug Product Technologies team at AIN.

* Role responsibilities and qualifications synthesized based on industry benchmark standards.

QUALIFICATIONS & REQUIREMENTS

REQUIRED QUALIFICATIONS

  • Doctorate degree with 8 years of drug product biotech experience OR Master's degree with 15 years of drug product biotech experience OR Bachelor's degree with 20 years of drug product biotech experience
  • 4 years of managerial or team/project/program leadership experience or experience directing resource allocation
  • Strong leadership and people-management capability
  • Ability to work in international matrix environments
  • Strong written and verbal communication skills

PREFERRED QUALIFICATIONS

  • 14+ years of drug product process development or manufacturing experience in biotechnology or pharmaceutical industry
  • Advanced degree in Biochemistry, Biochemical Engineering, Chemical Engineering or related discipline
  • Knowledge of cGMP regulations including FDA, EMEA and Health Canada
  • Drug product manufacturing and testing experience including process development, validation and commercial manufacturing
  • Experience with automation, AI, machine learning or LLM-enabled tools in compliant environments
  • Regulatory filing experience
  • Knowledge of statistics and data analytics
  • Project-management and Agile methodology experience
  • Experience leading cross-functional teams

REQUIRED VERIFIED SKILLS

Drug Product Technologies
drug product process development
pharmaceutical manufacturing
process validation
commercial manufacturing
cGMP
regulatory compliance
regulatory authoring
technical documentation
data analytics
process monitoring
automation
AI
machine learning
in-silico modeling
project management
people leadership

COMPENSATION & REWARDS

Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Competitive and comprehensive Total Rewards aligned with local industry standards; professional and personal growth support; collaborative and inclusive culture.
Amgen states that it provides competitive and comprehensive Total Rewards aligned with local industry standards, but the posting does not disclose a numeric salary range, bonus or equity amount.

ORGANIZATION CONTEXT & CULTURE

Amgen is a biotechnology company focused on researching, manufacturing and delivering innovative medicines for serious diseases, with therapeutic areas including Oncology, Inflammation, General Medicine and Rare Disease.

TEAM SIZE: Large global biotechnology organization; exact employee count not stated in the posting
INDUSTRY: Biotechnology / Pharmaceuticals
Culture: Amgen describes its culture as collaborative, innovative, science-based, inclusive and patient-focused, with emphasis on leadership, ethical conduct, continuous learning and professional growth.

EXPECTED CAREER ROADMAP

Potential progression may include Executive Director-level Process Development leadership, global Drug Product Technologies leadership, broader technical operations leadership or senior enterprise transformation roles across pharmaceutical development and manufacturing.

APPLICATION ADVISORY

Emphasize the required depth of drug product biotech experience and people leadership; highlight experience building or scaling teams and operating models; demonstrate expertise in process development, validation and commercial manufacturing; highlight cGMP and global regulatory knowledge; provide examples of digital transformation, automation, AI/ML or analytics implementation in compliant environments; demonstrate executive communication, risk management and cross-functional leadership; highlight experience working across international matrix organizations.

READY TO SUBMIT?

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