Job Title: Sr. Manager, R&D Operations – Biospecimen Strategy and Operations
Company: Amgen
Job ID: R-235506
Location: Hyderabad, India (On-Site)
Category: Project Management / R&D Operations
Date Posted: February 10, 2026
Experience Required: 8–12+ Years (Including 6+ Years in Biopharmaceutical R&D Preferred)
Employment Type: Full-Time
Amgen is seeking a seasoned and strategic Sr. Manager, R&D Operations – Biospecimen Strategy and Operations to lead operational excellence across Data Operations, Quality, Logistics, and Project Coordination functions in Hyderabad, India.
This leadership role is responsible for overseeing global biospecimen strategy, supplier governance, compliance oversight, and operational delivery across Amgen’s worldwide clinical and preclinical programs. The selected candidate will collaborate closely with US-based strategic leaders and global hubs to ensure 24-hour operational coverage, regulatory compliance, and continuous process improvement.
This position is ideal for experienced professionals with strong expertise in biopharmaceutical R&D operations, biospecimen management, clinical trial logistics, regulatory compliance, and cross-functional team leadership.
Provide leadership across Data Operations, Quality, Logistics, and Project Coordination teams in India.
Manage and develop managers, analysts, and specialists in partnership with global leadership.
Align with global hubs to ensure seamless 24/7 operational support.
Monitor service level agreements (SLAs), portfolio delivery timelines, and audit readiness.
Drive process standardization, automation, digital enablement, and operational efficiency.
Lead workforce planning, staffing strategy, and career development initiatives.
Act as primary escalation point for operational, compliance, and personnel performance issues.
Oversee global receiving, storage, tracking, and reconciliation of clinical and preclinical biospecimens.
Ensure accurate results management and integration with data management systems.
Lead supplier governance activities, including business continuity planning.
Oversee discrepancy resolution related to sample metadata and visit codes.
Support deviation management and compliance remediation activities.
Provide expert input to clinical operations teams regarding trial capabilities and biospecimen logistics.
Support audit and inspection readiness across global clinical programs.
Ensure compliance with GLP, GCP, and global regulatory guidelines, including IND-related documentation standards.
Oversee issue management and remediation processes to ensure regulatory adherence.
Promote risk mitigation and quality-driven operational controls.
Establish and track KPIs for biospecimen operations and supplier performance.
Lead cross-functional initiatives to enhance scalability and operational resilience.
Implement business process redesign initiatives to improve efficiency and transparency.
Drive results aligned with organizational goals and R&D portfolio priorities.
Candidates must meet one of the following education and experience combinations:
Doctorate degree with 2 years of industry-related experience
OR
Master’s degree with 6 years of management-related experience
OR
Bachelor’s degree with 8 years of management-related experience
Additionally Required:
Strong project management experience
Scientific and technical expertise in R&D operations, biospecimen management, or related functional areas
9+ years of experience in life sciences, including at least 6 years in biopharmaceutical R&D.
Functional expertise in one or more of the following areas:
Data Management
Biospecimen Management
Global Logistics
Clinical Project Management
Regulatory Submission and Inspection Management
In-depth knowledge of GLP, GCP, nonclinical study requirements, and IND regulatory documentation.
Demonstrated success leading global, matrixed teams.
Experience with enterprise systems and study planning tools such as:
Planisware
SmartSheet
Tableau
Veeva Platform
Strong scientific writing and technical documentation skills.
Proven ability to manage audits, inspections, and supplier governance frameworks.
Scientific and technical expertise in research and clinical trials
Advanced project and people management capabilities
Strategic leadership and stakeholder influence across geographies
Process optimization and operational planning
Conflict resolution and issue management
Financial and business acumen across R&D through commercialization
Analytical problem-solving and critical thinking
Strong presentation, negotiation, and communication skills
High accountability, adaptability, and integrity
Ability to collaborate effectively across global time zones
This senior leadership role offers the opportunity to shape global biospecimen strategy and R&D operational excellence within one of the world’s leading biotechnology companies. The position provides exposure to end-to-end clinical development processes, from research through regulatory submission and commercialization.
Professionals seeking advancement in R&D operations leadership, clinical biospecimen strategy, regulatory compliance management, and global pharmaceutical project management will find this role highly impactful and strategically significant.
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