Quality Control Data Analyst

Regeneron is currently looking for a Quality Control (QC) Data Analyst with a 1st shift, Monday-Friday, 8am-4:30pm schedule. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. Our QC Data Analysts are on the front line, performing a variety of activities to support release and stability programs of these lives changing products to ensure that they are safe for our patients.

As a QC Data Analyst, a typical day might include the following:

• Compile internally and externally generated data in support of compiling CofAs and SofAs.
• Prepare and provide CofAs and SofAs for all lot release materials
• Work with members of manufacturing, QA, RA, and R/D to provide updates/status of CofAs, SofAs, testing issues, etc.
• Trend QC product release data to support lot release and regulatory filings
• Act as a liaison between QC, Process Analytical Sciences, and Manufacturing group to provide trending analyses to support various activities such as manufacturing investigations, and validation studies.
• Assist in the implementation and maintenance of product release data trending program for each product candidate
• Presents trending data at the in-depth product review
• Write product annual release data trending reports
• Write lot specific data trending reports for each lot to be released
• Prepare and populate matrices (databases, spreadsheets) crafted to track testing and review status of release and stability samples, lot release data, etc.
• Compile data to support QC department metrics and performance tracking
• Assist with the improvement effort of coordinating the review and release process
• Attend meetings on behalf of Quality Control to update partners (Drug Supply, External Manufacturing, QA) as to status issues pertaining to release data
• Attend meetings to keep advised of development and manufacturing priorities and activities
• Ensures compliance with applicable cGMP regulations and SOPs
• Maintain and update relevant SOPs for data review and reporting as needed
• Meet specified timelines to support release and regulatory filings
• Follows all pertinent regulatory agency requirements.

This role might be for you if you:

• Enjoy working in a fast-paced environment and you have the innate ability to balance multiple tasks, prioritize them and execute them independently, while excelling at keeping all impacted parties well advised
• Have a basic understanding of Microsoft Suite (Word, Excel, Powerpoint)
• Can follow a set of instructions with outstanding attention to detail
• Enjoy working in a team environment and communicate effectively to accomplish shared goals
• Develop and drive scientific and/or business-related improvement ideas

To be considered for the QC Data Analyst you must be willing and able to work 1st shift, Monday-Friday, 8am-4:30pm. For various levels you must have the following:

Associate QC Data Analyst: BS/BA in Life Sciences or related field, or an equivalent combination of education and experience

QC Data Analyst: BS/BA in Life Sciences or related field, and a minimum of 12-18+ months of related experience; or an equivalent combination of education and experience

Sr. QC Data Analyst I: BS/BA in Life Sciences or related field, and 4+ years of experience; or an equivalent combination of education and experience

Sr. QC Data Analyst II: BS/BA in Life Sciences or related field, and 6+ years of experience; or an equivalent combination of education and experience.

Experience working in a cGMP pharmaceutical Quality Control Laboratory 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 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.