Principal Scientist, Product Transfer

HIKMA•Cherry Hill, NJ

1d•$98,000 - $161,700

About The Position

The Principal Scientist, Product Transfer is responsible for transferring products from Research and Development to Operations. The role supports process development and registration, scale-up and validation, commercial production start-up, and transfer to lifecycle support. The position minimizes obstacles during development, product transfer, validation, and commercialization through risk-mitigation strategies, sharing best practices, and influencing R&D and Operations colleagues. The role provides leadership and technical expertise throughout development and launch, helps ensure project timelines and product requirements are met, and supports continuous improvement through the initial commercial production phase. It also mentors colleagues and serves as a subject matter expert in core technologies and process engineering topics.

Requirements

Bachelor’s degree in Chemistry, Engineering, Pharmacy, or a related scientific discipline with 8 or more years of relevant pharmaceutical experience, or 10 or more years of relevant experience in another technical field; alternatively, a master’s degree with 6 or more years of pharmaceutical experience or 8 or more years in another technical field; or a Ph.D. with 4 or more years of relevant pharmaceutical experience or 8 or more years in another technical field.
Relevant experience includes 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 two or more 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 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 influence, leadership, and teamwork with development partners and customers during process development and registration of new product NDAs and ANDAs, ensuring project timelines are met.
Drive Process Risk Analysis, scale-up and transfer trials, and process validation for new products as the Operations team representative; influence development partners to meet quality, cost, and manufacturability requirements.
Prepare evaluation and validation protocols and reports, master formula cards, and other project documents on schedule.
Peer-review documentation to support right-first-time performance and ensure 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 initial commercial production until transfer to lifecycle support with Process/Quality Flow.
Mentor and develop members of the Product Transfer 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.
Employer-sponsored 401(k) with automatic enrollment at a pre-tax contribution rate of 4% of eligible pay; employer 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, and prescription drug coverage, plus voluntary benefits.
Employee discount program.
Wellbeing rewards program.
Career advancement and growth opportunities.
Tuition reimbursement.
Paid maternity and parental leave.