Project Manager Quality Control (Aseptic)
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, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases . Summary . Manage all Quality Control activities related to the implementation and support of new aseptic fill/finish production facilities . Essential Duties and Responsibilities include, but are not limited to, the following . Define, coordinate and manage timelines for all Quality Control activities related to aseptic fill line implementation and support, including . Equipment purchase and qualification o Laboratory design and buildout o Development of relevant standard operating procedures SOPs o Method validation/qualification . Develop and monitor project plans and schedules for QC onboarding of new sterile fill products . Technical evaluation of component and process changes for impact to QC functions and activities . Coordination of qualification/validation testing. Managing timelines for samples, testing and other deliverables . Participate in cross-functional teams to resolve product quality issues, corrective actions, investigations and develop/implement in process improvements . Draft relevant technical sections of regulatory documents . Provide support for investigations and other quality process documents . Lead cross functional teams and manages the deliverables for the assigned projects. Drives projects through completion within timeline, quality and budgetary constraints . Provide guidance to QC Management in assessing resource, equipment and space needs . Proactively identify issues and provide general guidance to resolve QC operational issues and works with leadership to develop solutions to meet objectives . Regularly interact with Sr. Management or executive levels. Exercise judgment and exert some influence on the overall objectives and long-range goals of the QC Department. Represent the department in relevant internal/external committees . Serve as a primary point of contact among functional areas for QC aseptic fill support . Lead special projects as assigned by supervisor/department management . Knowledge, Skills and Abilities . Excellent written, verbal and interpersonal communication skills . Ability to communicate at all levels and across various functions . Manage internal and external relationships . Ability to handle multiple projects and priorities with exceptional organizational and time management skills . Prioritize based on business needs . Identify and effectively communicate risks . Ability to problem solve and identify root cause . Continuously drive to improve processes for improved performance. Education and Experience . BS in microbiology or related field with 10+ years of relevant experience, preferably in the aseptic fill space in cGMP pharmaceutical or biotechnology industries. r PhD & 5+ years . Requires prior experience in aseptic filling and/or critical clean room operations. Familiarity with onboarding and scale up of aseptic fill . Experience in drug product component, package, label testing in a QC/GMP environment strongly preferred . Requires Project Management experience. PMP certification is preferred . Firm understanding of cGMPs, compendia USP/SMEWW/EP and Guidance Documents ISO, FDA 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, disability status, protected veteran status, or any other characteristic protected by law .