Regeneron Pharmaceuticals, Inc. Looking for Documentation Manager at Rensselaer, NY Full Time

We are currently looking to fill a Documentation Manager position with a 1st shift, Monday-Friday, 8:00am-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 Assoc Mgr Manufacturing Documentation Support supervises the document management process for manufacturing and leads the document lifecycle from creation of a document to final review and approval of implemented documents.

As a Documentation Manager, a typical day might include the following:

• Lead, create and maintain central location to archive manufacturing documentation.
• Handle the transition of our manufacturing records and logbooks from paper to electronic form in a MES system.
• Supervises Teams responsible for the organization and review of manufacturing documentation.
• Facilitate and catalogue manufacturing documentation i.e. deviations, investigations, CAPAs, manufacturing records and batch sheets.
• Leads document movement across all functional groups.
• Collaborates with Manufacturing, Document Control, IT and Quality Assurance to identify and implement improvements throughout the document management process.
• Prepare routine progress reports and metrics on manufacturing documentation for management.
• Responsible for ensuring documentation timelines are met applying communication and follow through with document owners.
• Leads versioning of batch records by executing implementation plans for document workflows.
• Coordinates day to day manufacturing operations and updates in the Oracle System.
• Develops and controls batch genealogies.
• May perform or assist personnel management functions including time sheet submissions, scheduling of vacations, personnel development, disciplinary actions, hiring, terminations and performance evaluations.
• Schedules individual and ongoing training.
• Participates in various site improvement projects.
• Provide guidance and coaching to develop others technical and management skills for career advancement.
• Prepares reports by collecting, analyzing, and summarizing information.
• Makes decisions; develops and implements policies.
• Ensures that policies and procedures are effectively administered and that they align with regulatory requirements.
• Performs personnel management functions (i.e. annual employee evaluations, coaching, etc.).

This role might be for you if:

• Clearly communicate status updates with peers and management.
• Build effective working relationships.
• Creative problem solver.
• Familiar with cGMP policies and practices.

To be considered for this role, you must hold the following education and/or work experience:

Associate Documentation Manager: Bachelor’s degree or higher and 6+ years in a cGMP environment, quality assurance, project management.

Documentation Manager: Bachelor’s degree or higher and 7+ years in a cGMP environment, quality assurance, project management.

Previous supervisory or leadership experience is a plus.

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.