Principal Scientist, Product Transfer

Hikma Pharmaceuticals USA Inc.•Cherry Hill, NJ

17h

About The Position

Hikma Pharmaceuticals USA Inc. is seeking a Principal Scientist, Product Transfer to transfer products from R&D to Operations. The role supports process development and registration, scale-up and validation, commercial production start-up, and transfer to lifecycle support. It works to minimize obstacles during development, product transfer, validation, and commercialization through risk-mitigation strategies, sharing best practices, and influencing R&D and Operations colleagues. The Principal Scientist represents Operations during process development and registration of new products, including NDAs and ANDAs, and helps ensure product quality, cost, manufacturability, and project timelines. The role also prepares and reviews project documentation, drives improvements during initial commercial production, serves as a subject matter expert in pharmaceutical technologies or process engineering, and mentors colleagues.

Requirements

Bachelor’s degree in Chemistry, Engineering, Pharmacy, or a related scientific discipline with at least 8 years of relevant pharmaceutical experience, or at least 10 years of relevant experience in another technical field; alternatively, a master’s degree with at least 6 years of pharmaceutical experience or 8 years in another technical field; or a Ph.D. with at least 4 years of relevant pharmaceutical experience or 8 years in another technical field.
Relevant experience in technology transfer, process or product development, quality assurance, manufacturing, and/or process engineering.
Expert knowledge of pharmaceutical development and manufacturing requirements, including cGMP, DEA, and FDA regulations and guidance.
Strong expertise in pharmaceutical production, formulation development, process scale-up, optimization, validation, and technology transfer.
Subject matter expertise in at least two core pharmaceutical processing technologies, with demonstrated ability to develop, scale up, and/or transfer complex pharmaceutical processes and dosage forms.
Expert knowledge of pharmaceutical processing equipment, including operation, critical equipment parameters, and troubleshooting.
Expertise in experimental design and methodology, including designing complex studies and analyzing data for process development, transfer, and validation.
Advanced problem-solving and root-cause investigation skills, including identifying complex technical issues and developing effective corrective actions.
Ability to apply technical expertise to influence product development, production, process optimization, and continuous improvement.
Proficiency with Microsoft Office.
Experience leading complex technical projects, cross-functional teams, and process improvement initiatives.
Ability to work independently, exercise sound scientific judgment, and lead strategic and tactical activities with minimal supervision.
Strong leadership, teamwork, and influencing skills, including experience facilitating complex cross-functional initiatives.
Ability to train, coach, and mentor colleagues on technical principles, pharmaceutical processes, equipment, and process optimization.

Nice To Haves

Experience with high-shear mixers, bin blenders, tablet presses, granulators, film coaters, and liquid mixing tanks.
Experience with statistical design and analysis software.
Experience with SAP, TrackWise, and/or Manufacturing Execution Systems (MES).

Responsibilities

Demonstrate leadership, influence, and teamwork with development partners and customers during process development and registration of new product NDAs and ANDAs, ensuring project timelines are met.
Lead Process Risk Analysis, scale-up and transfer trials, and Process Validation for new products as the Operations team representative; influence development partners to ensure products meet quality, cost, and manufacturability requirements.
Prepare evaluation and validation protocols and reports, master formula cards, and other project documents according to established timelines.
Peer-review documentation to support right-first-time performance and ensure the accuracy of product-transfer launch documentation delivered to customers, including Master Manufacturing Formulae, validation protocols and reports, and submission documentation.
Drive continuous improvement for launched products through the initial commercial production phase and until transfer to lifecycle support with Process/Quality Flow.
Mentor and develop other members of the PT Launch department.
Serve as a subject matter expert in core technologies and/or process engineering topics, such as equipment, statistical analysis, and validation approaches.

Benefits

Annual performance bonus, commission, and share potential.
Automatic enrollment in a Hikma-sponsored 401(k) program with a 4% pre-tax contribution rate; Hikma matches 100% of the first 6% of eligible pay contributed.
Paid time off starting at 20 days, prorated based on hire date, with additional days upon work milestone anniversaries.
Three personal days, prorated based on hire date.
Eleven company-paid holidays.
Health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and voluntary benefits.
Employee discount program.
Wellbeing rewards program.
Career advancement and growth opportunities.
Tuition reimbursement.
Paid maternity and parental leave.