Principal Scientist

Hikma Pharmaceuticals USA Inc. • Cherry Hill, NJ

6d

About The Position

As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them.
We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Principal Scientist to join our team. In this role, you will be serve as a key member of the Cherry Hill Technical Services Team, responsible for developing, implementing, and governing validation strategies for new launch, and validation lifecycle management. This role focuses on global alignment, standardization of validation approaches, and strategic oversight of Tech Transfer, PPQ campaigns, launch & lifecycle management programs, and product release readiness. This role partners closely with regional R&D, Equipment, Quality, Regulatory, and Engineering teams to ensure consistent, compliant, and innovative validation practices globally.

Requirements

• Bachelor's degree in Chemistry, Engineering, biotechnology or related scientific field is require.
• 7+ years proven experience within a regulated pharma industry
• Experience in global process validation strategy, governance, and regulatory compliance for ATMPs.
• Strong understanding of risk-based validation principles and Health Authority expectations.
• Demonstrate the ability to work effectively in cross-functional environment and influence global teams.

Responsibilities

• Author harmonized validation standards and templates across the global network.
• Provide strategic oversight for PPQ campaigns implemented at multiple sites, ensuring consistency and compliance
• Responsible for generation and execution of Batch size increase, Bulk Hold Extension, Process Validation, Room Transfer and Validation as a result of CAPA/Investigation.
• Support lifecycle improvement initiatives and evaluate digital for process optimization.
• Partner with regional and site teams to assess validation readiness for new technologies and platforms.
• Support and author regulatory submissions with globally aligned validation documentation and strategies.
• Able to coach mentor new hires and team members to drive consistency and compliance in documentation and execution practices.

Benefits

• Annual performance bonus, commission, and share potential
• Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute
• A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries
• 3 personal days (prorated based on hire date)
• 11 company paid holidays
• Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
• Employee discount program
• Wellbeing rewards program
• Safety and Quality is a top organizational priority
• Career advancement and growth opportunities
• Tuition reimbursement
• Paid maternity and parental leave

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level