Senior Manager/Associate Director, Formulation Development Group
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases. Summary We are seeking a candidate to lead the process development activities within the Formulation Development Group FDG of Regeneron Pharmaceutical Inc. at Tarrytown, NY. The Formulation Development Group FDG supports programs across all stages of clinical development and provides technical leadership towards clinical & commercial drug product process development and technology transfer. Additionally, FDG provides technical support towards GMP manufacturing, validation campaigns as well as post-launch activities for drug product. Responsible for leading the Drug Product process development group within FDG. The group will be accountable for all process development related activities for the drug product, with primary focus on late-stage development. The candidate will be a process development expert with experience in establishing robust scalable & transferable processes applicable to typical biologics drug product unit operations for vials and syringes for example, drug substance freezing/thawing, compounding, mixing, 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. Responsibilities Lead a team accountable for activities related to drug product process development, with primary focus on late-stage development . 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, filling, and lyophilization . Accountable for drug product process characterization, optimization, scale-up and technology transfer . Accountable for implementing and maintaining a state of the art process development laboratory in FDG . Responsible for effective risk assessments/FMEA for manufacturing processes . Responsible for technical leadership towards engineering, clinical and validation batches as well as post-launch activities . 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, External Manufacturing organizations . Interact with senior managers and scientists, peers and senior management to create efficient process development practices within FDG . Will consistently seek out, recognize and assesses new technologies to facilitate efficient and robust process development within FDG . Requirements Ph. D. in Chemical Engineering or Pharmaceutical Sciences or related discipline with 6+ years of relevant industry experience . Must be experienced in drug product process development, related engineering principles & methodologies, process characterization, optimization and technology transfer liquid & lyophilized modalities . Must be an experienced leader in a cross functional setting that requires frequent interaction with internal and external stakeholders relevant to early & late-stage product development . Must be experienced in managing early and late stage programs as a drug product lead . Must be experienced in people leadership. Must have provided guidance and training to scientists and managers Ph. D. and M. S. level , and must be a motivating and positive influence on the team . Must have excellent oral and written communication skills . Experience in implementation and managing a laboratory is preferred . Proven ability to quickly adapt to changes in project direction . Proven ability to think creatively, and obtain solutions to complex and diverse problems. Proven record of creative, productive, and insightful analysis and achievement . Proven ability to influence others to achieve results . This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business. To all agencies . Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.