Temp Drug Product MSAT Specialist

Supports the Drug Product Manufacturing Sciences and Technology (DP MSAT) departments through monitoring process performance, data trending, data analysis and/or laboratory testing. Provides support for the design and development of drug product processes and will be part of a team responsible for industrialization, troubleshooting and validation of drug product processes at manufacturing sites, both international and domestic.

A typical day might include, but is not limited to, the following: 

• Performing verified data entry tasks into electronic systems in a timely and efficient manner

• Tracking cycle time and metrics for data entry process

• Supporting the implementation, expansion and continuous improvement of Regeneron’s Application for Data Aggregation and reporting system

• Managing quality system events pertaining to data integrity and data management such as investigations, CAPAs, Change Controls and general document approvals

• Tracking trending process performance to establish/improve process capability, uses data analytics and/or laboratory testing to develop metrics and ensures process is operating within intended process control strategy

• Authoring policies, technical reports/protocols, change controls, etc. in support of cGMP activities

• Leading efforts associated with the drug product Continued Process Verification (CPV), documentation and trending of In Process Control (IPC) initiative

• Maintaining required training status on Regeneron specific work instructions and SOPs

• Collaborating with cross-functional teams to define and execute drug product process development and technology transfer activities

• Collaborating with peers, procures, implements and evaluates new technologies for potential future use in the drug product process

• Maintaining an awareness of relevant equipment and technology vendors, their existing and planned offerings and their anticipated performance

• Supporting process investigations and assists with product impact assessment for change controls and internal/external investigations, through laboratory investigations and/or data analysis

• Continuously drives to improve processes for improved performance 

• Travels up to 20%, as required

This role might be for you if:

• You have the ability to work independently or as part of a team

• You have the ability to communicate with transparency.

• You have experience working in complex and matrix environment

• You have Strong negotiation skills to reach consensus. Strong communication skills, both oral and written

• You have Technical knowledge in drug product manufacturing, product development and validation

To be considered for this position you must have a BS/BA in engineering or scientific discipline. For an Associate Specialist we would require 0-2 years experience. Specialist level would require 2+ years experience with pharmaceutical/biologics cGMP environment. For Sr Specialist this level would require 5+ years experience within pharmaceutical/biologics cGMP environment

#LI-Onsite #JOBSIEST #IRELIM 

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