HEALTHCAREFull-time
Director, Process Development - Drug Substance
By Admin · Research & Development (Lab & Science)
HYDERABAD (IN)ONSITEPOSTED: 9/11/2026
HEALTHCAREFull-time
HIRING ORGANIZATIONAMGENBiotechnology / Pharmaceuticals
ROLE OVERVIEW
Lead the new Drug Substance Technologies (DST) process development organization at Amgen Hyderabad, driving innovation in biomanufacturing and digital tools.
ROLE DEFINITION & RESPONSIBILITIES
- •Build and lead a new DST team at AIN with capabilities across technical documentation, regulatory authoring, data analytics, and automation
- •Work with functional partners to define roles and responsibilities
- •Manage the team for Drug Substance Technologies to ensure timely completion of goals
- •Set project timelines and priorities
- •Provide staff member supervision and on-going coaching
- •Strategically plan, analyze, and manage resources
- •Drive continuous improvement and escalation to management
Reporting Hierarchy: Reports to Executive Director, Process Development (with dotted line to DST leadership) • Team size: 15-30+
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Doctorate degree and 8 years of drug substance biotech experience OR Master's degree and 15 years OR Bachelor's degree and 20 years
- 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
- •Advanced Degree in Biochemistry, Biochemical Engineering, Chemical Engineering, or related discipline
- •Knowledge of cGMP regulations (FDA, EMEA, Health Canada)
- •Experience applying automation, AI, ML, or LLM-enabled tools
- •Strong leadership and executive communication skills
REQUIRED VERIFIED SKILLS
Drug Substance Technologies
Process Development
cGMP Regulations
Biomanufacturing
Leadership
Resource Management
Regulatory Authoring
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Comprehensive health insurance, retirement plans, wellness programs, and executive performance bonuses
Top-tier executive compensation package tailored for senior leadership roles in the biotechnology sector.
ORGANIZATION CONTEXT & CULTURE
Amgen harnesses the best of biology and technology to fight the world's toughest diseases and make people's lives easier, fuller, and longer.
TEAM SIZE: 25,000+ employees
INDUSTRY: Biotechnology / Pharmaceuticals
Culture: Amgen fosters an award-winning collaborative, science-based culture committed to serving patients living with serious illnesses.
EXPECTED CAREER ROADMAP
Exceptional executive leadership pathway into VP or global head roles within Amgen's technical operations and process development hierarchy.
APPLICATION ADVISORY
Highlight your extensive biopharmaceutical process development experience, leadership scale, and background in cGMP compliance in your resume.
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
Verify your capability profile and matching credentials before submitting direct applications.