Regeneron is currently looking for a Manufacturing Sciences & Technology (MSAT) Specialist role within Industrial Operations and Product Supply. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. The MSAT Specialist provides key technical support for internal and external technology transfer of biopharmaceutical drug substance manufacturing processes for adeno-associated virus (AAV), plasmids, and proteins.
In this role, a typical day might include the following:
- Assess manufacturing requirements and capabilities prior to the transfer of new processes into the manufacturing facilities; generates facility fit assessments and high-level gap assessments.
- Accountable for generating and reviewing documentation supporting technology transfer (e.g., manufacturing records, process descriptions, memos, detailed gap assessments, as appropriate).
- Gathers, trends and analyzes process generated data for chromatography, filtration, and formulation operations. Summarizes findings in memos, reports, and presentations.
- Monitors and prioritizes processes and troubleshoots technical difficulties as needed.
- Leads study teams and investigations during transfers, as applicable.
- Leads projects and initiatives associated with developing new technical support tools for technology transfers.
- Collaborates with managers to continuously assess and adjust technical support activities and functions.
- Generates options to resolve technical challenges and present them for endorsement.
- Works effectively and efficiently in a team-oriented environment to ensure maximum and high-quality output.
- Ensures all tasks are performed in a manner consistent with safety standards and within cGMP guidelines.
- Helps to build process knowledge base, controls for technology transfer and knowledge management and lessons learned database; identifies continuous improvement activities to improve performance.
- Assists in developing strategic long term vision for technical support activities impacting tech transfer projects
- Informs managers and stakeholders regarding technical document progress, investigations, challenges, metrics, etc.
This role might be for you if you:
- Work effectively and efficiently in a team-oriented environment to ensure maximum and high-quality output.
- Ensure all tasks are performed in a manner consistent with safety standards and within cGMP guidelines.
- Have experience gathering, trending and analyzing process-generated data; summarizes findings in memos and reports and presentations.
- Are willing and able to travel up to 10-15% travel may be required in support of tech transfer activities.
To be considered for the Manufacturing Sciences & Technology Specialist you must be willing and able to work Monday-Friday, 8am-4:30pm and travel occasionally. You must have a BS/BA in an engineering or related scientific discipline For various levels you must have the following:
- Associate MSAT Specialist: 0-2 years of relevant experience
- MSAT Specialist: 2+ years of relevant experience
- Sr. MSAT Specialist: 5+ years of relevant experience
Academic or industrial experience with cell, gene, or viral vector therapy delivery modalities, biopharmaceutical process development, or manufacturing process engineering experience is preferred. Level is determined based on qualifications relevant to the role.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and 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. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
Salary Range (annually)