Director, QA Microbiology (Drug Product MFG)

We are currently looking to fill a Director QA Microbiology position. This position is the lead for the Regeneron Fill Finish Facility will lead a team of QA Microbiology professionals. This role is responsible for working with management to drive and implement policy to ensure all protocol and SOPs are aligned.

In this role, a typical day might include the following:

• Organization Management and Support of QA for Microbiology:
  
  • Lead team members in all aspects of QA Microbiology and performance management
    
• Drug Product Final Fill Operational Microbial Control Oversight:
  
  • Make decisions, develop and influence policies related to microbial control
    
  • Observe microbial and aseptic practices in classified areas and propose improvements
    
  • Resolve problems, identify trends, and make system improvements
    
  • Maintain current knowledge in microbiological practices and methods as they relate to industry and Regeneron expectations
    
  • Support the review of microbial control related documents, including but not limited to, SOPs, Validation and Qualification documentation, Study Protocols, technical documents, work instructions, Instructor Led Trainings (ILCs), and On-The-Job Trainings (OJTs)
    
  • Provide technical expertise for investigations pertaining to microbial contamination to assure effective root-cause analysis, corrective action plan development, product impact assessment and remediation plans
    
  • Analyze Environmental Monitoring (EM) data and provide guidance for trending
    
  • Create microbial and aseptic training scenarios and presentations including, but not limited to, hands-on simulated production scenarios, presentations regarding process steps, job expectations and regulatory requirements and general information intended to expedite development of personnel
    
• Support CMO Microbial Control Oversight and Investigations:
  
  • Serve as the microbiology authority for CMOs
    
  • Serve as the microbiology guide in quality audits of CMOs, provide information to aid in the generation of audit reports
    
• Collaborate with QA Microbiology Leadership and Cross Functional Teams:
  
  • Foster collaborative working relationships between Regeneron departmental representatives
    
  • Serve as a subject matter expert (SME) to present topics to management and during inspections
    
  • Maintain consistency of IOPS Microbial programs and initiatives across multiple sites through procedures and education of personnel
    
• Regulatory Inspection Preparation:
  
  • Perform facility walkthroughs as needed for inspection readiness
    
  • Support logistics associated with regulatory inspections
    
  • Effectively communicate concerns to leadership
    
  • Provide guidance for responding to inspection findings and communicate updates, metrics and outstanding items to senior personnel
    
• Ability to travel domestically and internationally 10% or less
  

This role may be for you if you:

• Have experience in quality control microbiology, quality assurance and regulatory inspections for Biological pharmaceuticals
  
• Excel in a quality driven organization
  
• Have an understanding of biologics manufacturing operations
  

To be considered for this role you must hold a Bachelors degree in Life Sciences or related field and the following amount of related experience, preferably in the pharmaceutical or biotech industries or related field, for each level:

• Associate Director 10+ years
  
• Director 12+ 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 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)
$139,200.00 - $270,300.00