Job Title: Principal Scientist, Product Transfer
Location: Cherry Hill, NJ
Job Type: Full time
Req ID: 12822
About Us:
As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ mission is to bring Better Health. Within Reach. Every Day.® for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 800 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 32 manufacturing plants, three R&D centers, and 9,500+ employees worldwide, we are always hard at work creating high-quality medicines and making them accessible to the people who need them.
Description:
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 Prinicipal Scientist, Product Transfer to join our team.
In this role, you will be responsible for transferring products from R&D to Operations, including supporting process development and registration, performing scale-up and validation, start-up of commercial production, and transfer to lifecycle support. Minimize obstacles during development, product transfer, validation, and commercialization through utilization of risk-mitigation strategies, best practice sharing, and influence with R&D and Operations colleagues.
Key Responsibilities:
Demonstrate influence, leadership, and influential teamwork skills with development partners/customers during the process development and registration of new product NDAs and ANDAs, ensuring that all project timelines are met.
Drive Process Risk Analysis, Scale-up/Transfer trials, and Process Validation of new products as the Operations team representative, and influence development partners to ensure that new products meet requirements for quality, cost and manufacturability.
Prepare evaluation protocols/reports, validation protocols/reports, master formula cards and other documents for assigned products/projects to meet established project timelines.
Perform peer review of documentation to drive right-first-time performance of department and to ensure accuracy of PT Launch documentation that is delivered to customers (e.g. Master Manufacturing Formulae, validation protocols and reports, submission documentation, etc...).
Drive continuous improvement activities for launched products through initial commercial production phase, until transfer of launched products to lifecycle support with Process/Quality Flow.
Mentor and develop other members of the PT Launch department. Act as a subject matter expert on core technologies and/or process engineering topics (e.g. particular pieces of equipment, statistical analysis, validation approaches, etc.).
Qualifications:
We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them:
B.S. in Chemistry, Engineering, Pharmacy, or related scientific discipline with 8+ years of relevant pharmaceutical experience, or 10+ years of relevant experience in another technical field; M.S. with 6+ years of pharmaceutical experience or 8+ years in another technical field; or Ph.D. with 4+ years of relevant pharmaceutical experience or 8+ years in another technical field. Relevant experience includes technology transfer, process/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…