Job Description
Within this role you will be responsible to provide key technical support for internal and external technology transfer of biopharmaceutical drug substance manufacturing processes for monoclonal antibodies/therapeutic proteins and provide post transfer support.
This is a 12-month temporary contract
As a Temp MSAT Specialist, a typical day will include, but is not limited to, the following:
- Assessing manufacturing requirements and capabilities prior to the transfer of new processes into the manufacturing facilities
- Generating facility fit assessments and high-level gap assessments
- Generating and reviewing documentation supporting technology transfer (e.g., master plans and reports, process descriptions, memos, detailed gap assessments)
- Presenting options to resolve technical challenges and seeking endorsement
- Analysing process-generated data; summarizing findings in memos, reports, and presentations
- Reviewing manufacturing documentation generated by the receiving unit (manufacturing records, batch sheets, changeover protocols, SOPs, etc.)
- Participating in study teams and investigations both internal and external
- Troubleshooting technical difficulties as needed and prioritizing processes
- Building process knowledge base, controls for technology transfer, knowledge management and lessons learned database while identifying continuous improvement activities to improve performance
This role might be for you if:
- You have a proven ability to work independently or as part of a team
- You possess strong trouble-shooting and problem solving skills
- You have strong attention to detail & excellent written and oral skills
To be considered for this opportunity you should have a BS/BA in an engineering or scientific discipline or equivalent combination of education and experience.
#REGNIELSM #LI-Onsite #IRELIM #JOBSIEST
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.