Process Sciences Associate (Change Management)

Regeneron is currently looking for a Process Sciences Associate to join our PSPDE (Process Sciences Drug Product Engineering Team). This role supports change management activities including Supplier, CMO and Partner Change Notifications, internal Change Control and CAPA record management in the manufacture of Drug Product!

As a Process Sciences Associate, a typical day might include the following:

• Serves as an expert for manufacturing support activities.
• Performs product impact assessments.
• Leads all aspects of lifecycle activities of established programs for manufacturing processes, including impact assessment, change control, and document generation or revision.
• Evaluates the impact of Change Control records on Drug Product and Combination Product activities both on a site-specific and global level.
• Presents findings, conclusions, or project achievements at group and interdepartmental meetings.
• Communicate information on current process data and other IOPS initiatives which may impact process development and/or technology transfer.
• Participates in process and quality risk assessments.
• Presents process monitoring data to IOPS Management as needed.
• Assists in solving activities aligning with the manufacturing process.
• Reviews and/or approves Manufacturing documentation associated with the transferred process.
• Facilitates/coordinates interdepartmental discussions in support of process sciences validation, device development, and IPC (In-Process Controls) activities in accordance with agreed-upon timelines.
• Presents findings at team meetings and multi-functional meetings.
• Produces and maintains accurate records.
• May lead special projects.
• Tracks team activities and timelines to ensure that the results within the project plan are met and are timely.
• Coordinates the exchange of data and other information between Process Sciences, CMC Regulatory, Project Management, and Quality Assurance.

This role might be for you if you:

• Can work independently or as part of a team.
• Have technical knowledge in drug product manufacturing, drug product or device development or validation.
• Enjoy problem-solving through developing creative solutions to sophisticated problems.
• Enjoy leading independent and/or collaborative, long and short-term projects.
• Portray excellent interpersonal, written, and oral communication skills.
• Can build effective working relationships across a wide network.
• Possess solid understanding of word processing, spreadsheet, database management, and presentation software.

To be considered for the Process Sciences Associate you must have a BS/BA in Life Sciences or related field. You must be willing and able to work Monday- Friday, 8am-4:30pm. For various levels you must have the following:

Process Sciences Associate I: BS/BA in Life Sciences or Engineering disciplines.

Process Sciences Associate II: BS/BA Life Sciences or Engineering disciplines, 2+ years of relevant experience.

Level is determined based on qualifications relevant to the specific role.

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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)

$55,700.00 - $103,700.00