Manager, Reagents Manufacturing

Covaris, LLC. (www.covaris.com) is a profitable technology company headquartered in Woburn, Massachusetts, USA. Covaris has developed a proprietary and patented Adaptive Focused Acoustics™ (AFA) technology platform, which is utilized in sample preparation processes in the analytical and life sciences industries worldwide. Covaris AFA has become the gold standard for DNA fragmentation in the Next Generation Sequencing market. Covaris AFA is used by the largest and most productive genome centers worldwide.

Covaris AFA and other proprietary products have unique and competitive advantages for scientists in genomics, proteomics, and epigenomics research.

Summary:

We are seeking a highly skilled and detail-oriented Reagents Manufacturing Manager to lead our Reagent Manufacturing Team. This role focuses on small to medium volume production. This position will oversee daily production activities, optimize processes, and work collaboratively with R&D on New Product Introductions in a regulated environment. Key responsibilities also include management of semi-automated pumps and dispensing equipment, overseeing inventory and manufacturing records, and ensuring compliance with ISO 13485 and IVDR standards.

Essential Responsibilities: The employee may be required to perform all or a combination of the following essential responsibilities as determined by business necessity.

• Manage a small team of manufacturing technicians
• Partner with Procurement, Sales, and Customer Service teams to coordinate and execute weekly production planning
• Design workflows and operating procedures for small to medium-scale production using benchtop pump, pipetting and dispensing equipment ensuring consistency, efficiency, and quality
• In-depth knowledge of aseptic techniques, sterile processes and cleanroom manufacturing best practices
• Strong understanding of GMP and GDP principles and their application in manufacturing
• Proficient in data analysis, statistical process control (SPC), and process validation
• Work within ERP, electronic databases and eQMS platforms to maintain inventory, quality and production data
• Demonstrate a results-driven mindset, consistently exceeding expectations while championing a culture of continuous improvement
• Communicate effectively both verbally and in writing
  
  

Non-Essential Responsibilities: In addition to the essential responsibilities listed above, the employee may be required to perform other non-essential functions. Employees are required to follow any other job-related instructions and to perform any other job-related duties requested by their supervisor.

Qualifications:

• Bachelor’s degree in Chemical Engineering, Biochemical Engineering, or a related field; Master’s degree preferred.
• Minimum of 5 years of experience in process engineering within a regulated manufacturing environment (e.g., ISO 13485 or FDA-regulated industries).
• Proven expertise in small- to medium-scale reagent manufacturing with bench-scale equipment
  
  

Reasonable Accommodation: Covaris is committed to the spirit and the letter of the Americans with Disabilities Act. All requirements are subject to possible modification to reasonably accommodate otherwise qualified individuals.