In this position you be responsible for providing technical support on the manufacturing process and be heavily involved in technical transfer of processes, along with being a key member in the implementation of large-scale commercial manufacturing production program.
A typical day might include, but is not limited to, the following
Liaising with the process science/technology transfer teams in relation to the transfers and startup of the manufacturing processes.
Providing technical input into manufacturing records, batch sheets and procedures
Writing, reviewing, Standard Operating Procedures and other controlled documents
Providing technical input to resolve process problems both on and off the production suites
Working closely with other cross functional groups such as Maintenance, Process Sciences, Engineering to resolve process issues and implement improvements
Supporting manufacturing personnel to increase technical knowledge of critical process steps on the floor
Supporting Manufacturing personnel on implementing improvements to the process or work systems in the suites
Modifying process method files through the quality system.
Supporting CAPA implementation on process related improvements
Supporting all aspects of the manufacturing processes according to approved protocols, regulation, and schedule
Supporting investigations into process variances according to site procedures
Communicating with supervisors regarding changes to the process or material used within the process
Working cross functionally with other 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 input
Representing manufacturing during regulatory and client audits
Implementing continuous improvement initiatives
This role might be for you if:
Enjoy working independently in a fast-paced, team environment, collaborating with others to tackle complex problems and are comfortable with quickly shifting priorities
Have a strong organisation, time management, and problem-solving skills
Have excellent interpersonal, verbal and written communication skills
Can think critically and demonstrate problem-solving skills
To be considered for this position you must hold a BS/BA/BEng in Life Sciences or related field along with 2+ years of relevant GMP experience in a Drug Substance Biotech facility.
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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.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.
