Assists in the direction of all facets of commercial and/or clinical scale production of recombinant proteins in Raheen.As an Associate Director Biotech Production within Upstream Operations, a typical day may include, but is not limited to, the following:Providing leadership, vision, and management to the commercial scale manufacturing teamDirecting commercial scale manufacturing of recombinant proteins according to approved protocols, regulation, and scheduleDeveloping high level schedules, detailed production plans, and material requirementsCommunicating with Supervisors/Managers on schedules and materialsImplementing new recombinant protein production processes transferred by the Tech transfer/Process Development teamGuiding Validation activities involving Manufacturing equipment and processesWorking cross-functionally with other departments, such as Facilities, Engineering, Process Development, Process Analytical Sciences, Regulatory, Quality Assurance and Quality ControlFormulating and recommending manufacturing policies, schedules, procedures and programsPerforming personnel management including scheduling of vacations, personnel development, and performance evaluations. Along with working closely with HR to ensure teams are resourced adequatelyLeading routine meetings to supervise key manufacturing and support activities.Recommending capital expenditures and aids in the realisation of capital projectsEnsuring safety standards are maintainedTracking relevant technical and business process metrics to ensure operations are performing effectively and efficientlyPreparing and administrating expense and capital budgetsPerforming cGMP audits of production area and represents manufacturing during regulatory and client auditsDeveloping and implementing comprehensive manufacturing activities reportsReviewing, and/or approving Standard Operating Procedures, specifications, regulatory filing, or other controlled documents as neededLeading and driving continuous improvement initiativesThis role might be for you if:You have expert knowledge of Upstream Operations within Biopharma and have strong knowledge of industry practices and regulations.You are a dedicated leader who can train, mentor and lead employeesYou are a self-starter with the ability to operate in a multifaceted environmentYou have the ability to maintain integrity and honesty at all timesTo be considered for this position you must hold a BA/BS in any of the physical or biological sciences, or chemical engineering and 10+ years biopharmaceutical/biotech experience in a GMP production facility or equivalent combination of education and experience#REGNIELSM #LI-Onsite #JOBSIEPRDoes 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.S.-based 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.
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