Head of Validation | BioNJ Talent Services

Head of Validation

Contact Information
Contact Name: 
careers@edgetherapeutics.com
Organization Name: 
Edge Therapeutics, Inc.
Position Location: 
Berkeley Heights, NJ
Email to Apply: 
careers@edgetherapeutics.com
Company Profile: 

Edge Therapeutics, Inc. (Edge) is an entrepreneurial, fast-paced, dynamic and collaborative, publicly-traded biotech company, with a lead product for the treatment of ruptured brain aneurysms that is currently in Phase 3 clinical trials.     http://www.edgetherapeutics.com/
 
Situated in a lovely office park in Berkeley Heights, NJ, Edge’s offices are accessible, appealing, ample, and invite both private and group work.  Small in number, big in vision, mission and values, Edge’s collegial, diverse, talented, and passionate team is striving to get potentially life-saving products to patients. 

Job Description:

We are seeking a Head of Validation, Technology and Engineering who will report to the Director of Technical Operations and will lead all validation activities for the company. It is a highly visible position that is critical to the overall success of Edge Therapeutics, Inc. The incumbent will be the primary liaison with Edge’s contract manufacturing organizations for qualification and validation activities of manufacturing processes (including cleaning & computer), equipment, and utilities for active pharmaceutical ingredients, critical excipients and finished product. 

Additional responsibilities include providing technical assistance, as needed, for manufacturing and engineering troubleshooting.  This leader will also be responsible for the coordination of supportive validation activities (such as laboratory testing, calibration, scale-up and engineering studies) and assurance that the necessary project documentation is complete, accurate, and in compliance with cGMP regulations.  S/he will be responsible for master planning and interface with Edge’s Quality group per the change control process.
 

Qualifications: 

We are eager to hear from you if you meet or exceed the following partial list of minimum educational, experiential and skill requirements:   
• B.S. degree in pharmaceutics or chemistry; degree in chemical, biochemical, or mechanical engineering preferred
• Six Sigma certification is highly desirable
• 5-8 years of hands-on validation, engineering, and technical experience in a biopharmaceutical or pharmaceutical production environment, including experience with the following:
¬ Cleaning verification and validation programs
¬ Writing, executing and summarizing validation protocols and testing procedures for equipment/systems
¬ Contract manufacturing organizations
¬ Participation in internal and external audits
¬ Microsoft Office Suite:  Word, Excel, and SharePoint, essential
¬ Kaye thermal mapping instruments, strongly desired
¬ Computerized compliance (TrackWise), calibration, and PM enterprise systems, strongly desired
¬ At least 1-2 years in a supervisory capacity or project management in a team setting
• Demonstrated ability to lead troubleshooting activities and complex investigations, and provide technical support
to both Operations and Quality systems.
• Ability to effectively manage multiple projects simultaneously
• Flexibility to work off-hours and weekends, as required to support manufacturing plant projects
• Able and willing to travel approximately 25%, both domestically and internationally
• Live within commuting distance of Berkeley Heights, NJ (Preferred)
• Able to consistently demonstrate the Behaviors that Define Edge

Please write "Validation" in the Subject line of your email and send a cover letter and resume to: careers@edgetherapeutics.com.

We will respond promptly to individuals whose qualifications most closely match the position requirements.

Additional Job or Internship Information
Position Type: 
Full time job
Function: 
Manufacturing
Number of Openings: 
1
Paid: 
Yes
Relocation Package Offered?: 
Maybe