In this role you will provide technical support on the manufacturing process and be a key member in the implementation of large-scale commercial manufacturing production program. You will be heavily involved in technical transfer of processes.
As a Process Specialist-Manufacturing a typical day might include, but is not limited to, the following:
Liaise with the process science/technology transfer teams in relation to the transfer and startup of the manufacturing processes
Key person for technical input into manufacturing records, batch sheets and procedures
Write, review, Standard Operating Procedures and other controlled documents as needed
Provide technical input to resolve process problems both on and off the production suites
Work closely with other cross functional groups such as Maintenance, Process Sciences, Engineering to resolve process issues and implement improvements
Support manufacturing personnel to increase technical knowledge of critical process steps on the floor
Support Manufacturing personnel on implementing improvements to the process or work systems in the suites
Support RFT programs on the floor
Responsible for modifying process method files through the quality system
Support CAPA implementation on process related improvements
Support all aspects of the manufacturing processes according to approved protocols, regulation, and schedule
Involved in supporting investigations into process variances according to site procedures
Communicate well with supervisors regarding changes to the process or material used within the process
Interface with other departments, such as Facilities, Process Development, Engineering, Process Analytical Sciences, Regulatory, Quality Assurance and Quality Control
Work to the highest safety standards. Supports safety improvements which require technical input
Represent manufacturing during regulatory and client audits
Implement continuous improvement initiatives
To be considered for this opportunity you should have a BS/BA/BEng in Life Sciences or related field along with:
Associate Specialist: 0-2 years of relevant cGMP manufacturing/engineering/scientific experience in a Drug Substance Biotech facility or equivalent combination of education and experience
Specialist: 2 years of relevant cGMP manufacturing/engineering/scientific experience in a Drug Substance Biotech facility or equivalent combination of education and experience
Sr Specialist: 5 years of relevant cGMP manufacturing/engineering/scientific experience in a Drug Substance Biotech facility or equivalent combination of education and experience
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.