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The Sr. Principal Scientist will be accountable for all process development related activities for the drug product, with focus on late-stage development for mAb & related modalities. Additionally, primary responsibility for the incumbent will also be process capability build for gene therapy modalities (in particularly, mRNA-LNP systems). The candidate will be a process development expert with experience in establishing robust scalable & transferable processes applicable to typical drug product unit operations (for example, drug substance freezing/thawing, compounding, mixing, tangential flow filtration, UF/DF, filling, and lyophilization). Additionally, the position will be responsible in maintaining a successful network with external and internal stakeholders and will provide technical support towards non-GMP & GMP operations.A typical day in this role might look like
Lead a team accountable for activities related to drug product process development, with primary focus on late-stage development. Will be accountable for development of scalable and robust processes (using engineering principles and methodologies) applicable to typical biologics unit operations for vials and syringes (for example, drug substance freezing/thawing, compounding, mixing, tangential flow filtration, UF/DF, filling, and lyophilization)
Lead and support building of process development capabilities for LNP-based systems in FDG that would be used as a platform to deliver RNA therapeutics.
Lead and support Lyophilization and Spray drying process for different modalities (Ex: mAbs, nucleic acids)
Develop and qualify scaled-down model systems for drug product manufacturing process development.
Interact effectively & build successful relationships with members of the FDG, and with other Regeneron stakeholders (Drug Product & Drug Substance Manufacturing, Project Management, Quality, Analytical Development/QC, Regulatory CMC, Regeneron Genetic Medicines, External Manufacturing organizations).
Draft and review technical reports/protocols and participate in data presentations to the Sr. Management
Lead the team to execute project plans supported by strong scientific rationales and technical approaches, while cognizant of project priorities, milestone deliverables (e.g., memos, reports) and timelines
This Job Might Be for You If you.
Have a strong initiative and drive to complete challenging tasks as well as building capabilities ground up.
You have Out- of Box thinking and strong problem-solving skills.
Proactive leadership skills, agility and can quickly adapt to changes to support ever-changing timelines for pipeline modalities.
To be considered for this a degree in Biomedical Engineering, Chemical Engineering, Pharmaceutical Sciences, or related field is required. (Ph.D. with 7+ years of relevant experience).The ideal candidate will have a solid understanding of drug product process development operations for biologics and nucleic acid therapeutics including but not limited to Mixing , Tangential Flow Filtration (TFF), Lyophilization, Spray drying process, Analytical characterization for protein andnucleic acid therapeutics such as HPLC-based chromatographic techniques (icIEF, SEC, IEX), Biophysical methods (DLS, DSC, and UV-Vis), and Particle characterization methods (MFI and HIAC).Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.Salary Range (annually)$141,800.00 - $231,400.00
