Manufacturing Process Specialist

Performing a leading role in the start-up of Regeneron's Advanced Therapies facility, from design through commissioning & qualification, and in to clinical and commercial manufacturing. Provides technical direction through start up to design a digitally integrated manufacturing platform for manufacture of drug modalities including AAV Gene Therapies, Plasmids and Bio-Conjugates. As a Manufacturing Process Specialist a typical day might include, but is not limited to, the following: Developing site strategies and policies e.g. Digital Strategy, Cross contamination and contamination control strategies Participating in Risk Assessments supporting start-up to ensure robust risk analysis Supporting the facility detailed design Ensuring Data Governance and Data Integrity principles are integrated in to all aspects of operations Owning the development of manufacturing GMP documentation including SOP's, WI's, Job aids and Manufacturing Production Records Utilising process mapping in the development of both GMP and Business Processes Supporting GMP release, ensuring delivery is robust Collaborating with Mid-scale manufacturing to leverage expertise in single use manufacturing processes & clinical manufacturing Working closely with the MSAT department and the sending unit to tech transfer AAV's, Plasmids and Bio-conjugates Leading investigations into process variances according to site procedures and acts as Area manager on investigation approvals Ensuring that policies and procedures are successfully implemented and that they comply with regulatory requirements Leading and supports process investigations, ensuring robust CAPA's are identified Mentoring manufacturing personnel to increase technical knowledge of production processes. Supporting Manufacturing personnel on implementing improvements to the process and/or work systems. Supporting CAPA implementation on process related improvements Supporting onsite informative programs to enhance technical competence of manufacturing personnel Supporting all aspects of the downstream manufacturing process according to approved protocols, regulation, and schedule Working cross-functionally with departments, such as Facilities, Process Development, Engineering, Process Analytical Sciences, Regulatory, Quality Assurance and Quality Control Ensuring the highest safety standards and supporting safety improvements which require technical/engineering input Ensuring manufacturing are audit ready at all times and performs audits of production area Representing manufacturing during regulatory and client audits Leading and implementing continuous improvement initiatives This role might be for you if: You have experience working in gene therapy manufacturing You can demonstrate technical knowledge in drug product manufacturing You have the ability to maintain integrity and honesty at all times You have the ability to research, analyse and extrapolate critical regulatory information To be considered for this position you must hold BS/BA/BEng in Life Sciences or related field. For Specialist level you must have 3+ years related experience and for Sr Specialist 5+ years of relevant cGMP manufacturing/engineering/scientific experience in a relevant industry. Strong Technical knowledge of the Downstream Process preferable. 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.