Spacer ImageSpacer ImageSpacer Image
Spacer Image

Job (this posting is now closed/inactive)


Spacer Image
Spacer Image

General Information

(3595005)

Job title: Reagent Manufacturing Director [Pos ID: 10039]
Spacer Image
Job location: Durham, NC  27709 United States
Requisition code:
Date posted: 03/10/2017
Compensation: Salary
Benefits
Job category:Manufacturing and Production
Product Development
Research and Development
Employment type:Full time
Spacer Image

Job Description


Spacer Image
Baebies Inc. (www.baebies.com) is a well-funded growth-stage company that develops and commercializes products for testing in the newborn screening market. The company’s FDA-cleared product is sought by US public health labs where the majority of biochemical newborn screening occurs.

DUTIES AND RESPONSIBILITIES:
• Participate in reagent product development activities beginning at the initiation of the development phase; work closely with reagent development personnel
• Own reagent manufacturing process development activities; build reagents for product validation or earlier
• Oversee the preparation of manufacturing documents including SOPs and specifications. Work with the team for the successful transfer of reagents, SOPs, and other needed documents to Operations
• Develop an understanding of required production volume
• Drive purchase of capital equipment for both manufacturing and measurement for new products
• Install and validate manufacturing and measurement process tools and equipment
• Develop and implement methods to track performance of reagent production processes
• Maintain QSR compliant records for reagent products and components
• Drive continuous improvement in the quality and reliability of reagent products
• Address the reagent component of customer complaints, product nonconformance, corrective actions, and other performance problems rapidly and thoroughly; troubleshoot, document, develop solutions and implement process changes
• Organize and lead ongoing reagent stability test program
• Perform all activities in compliance with GMP, regulatory and safety policies
Spacer Image
Spacer Image

Job Requirements


Spacer Image
QUALIFICATIONS/CHARACTERISTICS:

• Very strong reagent development skills, particularly in transitioning reagent-based products to manufacturing
• Extraordinary attention to detail
• Deep understanding of system development and evaluation tools and processes such as DOE
• Deeply understands FDA-compliant quality system requirements for development and manufacturing
• Highly professional and interested in further professional growth
• Is strongly engaged by the company’s mission
• High integrity, insightful, passionate, industrious, and highly intelligent
• Must be able to work independently and as a member of a multidisciplinary team
• Excellent verbal and written communications skills; strong computer skills

EDUCATION AND EXPERIENCE REQUIRED:

• BS or greater in scientific discipline; chemistry/biochemistry degree or experience
• 10+ years’ experience in reagent/kit development and manufacturing
Spacer Image
Spacer Image
Spacer Image
Spacer Image