Manager, Process Validation Oversight

We are currently looking to fill a Manager, Process Validation Oversight position. This leads a department responsible for the oversight of qualification of the equipment, systems, and processes validation for our Contract Manufacturing Organizations (CMOs) and partner groups in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures.

In This Role, a Typical Day May Include

• Leads cross-functional teams in developing Validation best practices, standards and guidelines which includes exploring new techniques, methods, and other industry practices.
• Leads projects by developing appropriate plans, schedules, resource loading and other project deliverables as required Execution of validation projects and overseeing Validation projects as well as junior-level staff. Based on engineering specification, performs validation projects which include authoring protocols, executing validation protocols, and writing reports of validation results.
• Reviews and approves Validation protocols and summary reports generated by the Validation staff against standard operating procedures and policies as well provides guidance to Validation staff writing protocols and final reports.
• Leads team of Validations specialists who investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
• Approves various documents relating to area function, including those listed above.
• Provide direction and assign work to Validations Specialists to meet goals and timings.
• Coordinates prioritization of activities with area management.
• Responsible for compliance monitoring of area operations, including trending of failures and evaluating effectiveness of corrective actions.
• Reviews internal and external requirements and implements required processes, as needed, to meet expectations regarding Quality.
• Participates in regulatory and customer activities.
• Collaborates with functional departments to resolve issues.
• Manages projects and prepares status reports.
• Some travel may be required (approximately 25%)
  
  

This Role May Be For You If You

• Have previous quality or process validation experience in DS, FDS, DP, and LDP preferred
• Have an understanding of AAV (adeno-associated viruses), VLP (virus-like particles), si-RINA (small interviewing RNAs), or biologics manufacturing operations including monoclonal antibodies
• Enjoy leading and developing a team of Quality minded professionals.
• Have previous leadership experience including leading a team to meet department goals, performance evaluation/feedback, and mentorship.
  
  

Role

To be considered for this role you must hold a Bachelor's degree in Engineering, Chemistry or Life Sciences and the following minimum amounts of experience for each level:

• Associate Manager: 6 years
• Manager: 7 years
• Sr. Manager 8 years
  
  

May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.

#REGNQA

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 in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)

$89,100.00 - $199,000.00