Principal Scientist Product Transfer

Job description

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 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. Experience with equipment such as high-shear mixers, bin blenders, tablet presses, granulators, film coaters, and liquid mixing tanks preferred. Expertise in experimental design and methodology, including designing complex studies and analyzing data to support process development, transfer, and validation. Experience with statistical design and analysis software preferred. Advanced problem-solving and root-cause investigation skills, with the ability to identify complex technical issues and develop effective corrective actions. Demonstrated ability to apply technical expertise to influence product development, production, process optimization, and continuous improvement. Proficiency with Microsoft Office; experience with SAP, TrackWise, and/or Manufacturing Execution Systems (MES) preferred. 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, with experience facilitating complex cross-functional initiatives. Demonstrated ability to train, coach, and mentor colleagues on technical principles, pharmaceutical processes, equipment, and process optimization. Compensation: Base Salary : $98,000.00 to $161,700.00 annually. The compensation for this position will be determined during the interview process and will vary based on multiple factors, including, but not limited to, work location, prior experience and job-related knowledge, relevant skills and expertise, current business needs, and market factors. The Talent Acquisition team can provide more details about the specific salary range for the job location during the hiring process. What We Offer*: Annual performance bonus, commission, and share potential Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 4% 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 *Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms. Recruiters: Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma’s Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma. Equal Opportunity Employer: Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law. #LI-KJ1