In this position you will lead the day-day based technical support requirements of the manufacturing team. Provide technical direction and troubleshooting guidance. Maintain compliance by ensuring deviation investigations, change controls and CAPA's are delivered to a high standard and on time. As an Associate Manager/Manager Biotech Production (Downstream), a typical day might include, but is not limited to, the following: Ensuring all deviation investigations, CAPA's and change controls are delivered to a high standard and on time Ensuring that all documentation (SOPs, Manufacturing Records, Batch Sheets & Logbooks) is current, accurate and in accordance with regulatory requirements Supporting the technology transfer of recombinant proteins from US site to Irish site Being the primary liaison between Process Science and Manufacturing in relation to the transfer and start-up of the manufacturing process and also working with Engineering in relation to process improvement and robustness initiatives Preparing reports by collecting, analysing, and summarising information and trends. Preparing and presenting manufacturing data for review at the Product Performance and monitoring meeting Leading investigations into process variances according to site procedures. Providing technical input to resolve process issues. Implementing a contamination free program to ensure the highest process success rates Leading for all upstream contamination response activities. Working to the highest safety standards Working with other departments, such as Facilities, Process Sciences, Regulatory, Quality Assurance and Quality Control Supervising relevant technical and business process metrics to ensure operations are performing effectively and efficiently Performing cGMP audits of production area Representing manufacturing during regulatory and client audits Leading and implements continuous improvement initiatives This role might be for you if: You have expert knowledge of Downstream Operations within Biopharma and possess strong knowledge of industry practices and regulations. You are a dedicated leader who can train, mentor and lead employees You are a self-starter with the ability to operate in a multifaceted environment, able to work on your own initiative and within a team environment You have the ability to maintain integrity and honesty at all times To be considered for this position you must hold a BA/BS or higher in Biological Sciences or related field. For Associate Manager 7+ years of experience with Biological or Pharmaceutical manufacturing, with at least 2 years experience managing a team. Manager level requires you must have 8+ years experience within pharmaceutical/biotech GMP production facility and at least 3+ years leading teams. #REGNIELSM Does this sound like you? Apply now to take your first step towards living the Regeneron Way We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, 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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.