Sr. Process Specialist

Rensselaer, New York, United States of America
Jul 23, 2021
Required Education
Bachelors Degree
Position Type
Full time
We are currently recruiting for a Sr. Process Specialist who will be responsible for providing technical direction and resolution for issues on and off the production floor for aseptic, cell culture, or purification manufacturing. The successful person would be a key member of the large scale manufacturing program.

As a Sr. Process Specialist, a typical day might include the following:
• Provides technical input to resolve process issues both on and off the production floor.
• Supports Manufacturing personnel on implementing improvements to the process or work systems in the suites.
• Supports NOE's, EOE's & CAPA implementation on process investigations.
• Supports onsite educational programs to improve technical competence of manufacturing personnel.
• Supports all aspects of the aseptic, cell culture, or purification manufacturing process according to approved protocols, regulation, and schedule.
• May contribute to the technology transfer of the manufacturing process.
• Liaises with the process science/technology transfer teams in relation to the transfer and startup of the manufacturing process.
• Prepares reports by collecting, analyzing, and summarizing information and trends.
• Communicates well with supervisors on major problems regarding the process, schedules and materials.
• Helps guide and coordinate validation activities involving manufacturing equipment and processes.
• Collaborates with other departments, such as Facilities, Process Development, Engineering, Process Analytical Sciences, Regulatory, Quality Assurance and Quality Control.
• Works to the highest safety standards. Supports safety improvements which require technical/engineering input.
• Tracks and trends relevant technical and business process metrics to ensure operations are performing effectively and efficiently.
• May represents manufacturing during regulatory and client audits.
• Writes, reviews, and/or approves Standard Operating Procedures, specifications, regulatory filing, or other controlled documents as needed.
• Leads and implements continuous improvement initiatives.

To be considered for this opportunity you must hold a BS/BA in Life Sciences or related field and 5+ years of relevant cGMP manufacturing/engineering/scientific experience in a relevant industry. Strong Technical knowledge of bioprocessing would be preferable. Level of role dependent on 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 amazing benefits including health and wellness programs, fitness centers and stock for 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 maternity 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.