OVERVIEW:

Our vision is creating future cell therapy miracles together.  We are a leading global contract development and manufacturing organization dedicated to the advancement of cell and gene therapy products. We believe in the transformative potential of cell and gene therapies and we are shaping the future of medicine.  We open doors in the regenerative medicine industry for those looking to transform medicine while continuously improving an innovative, growing company.

The Manager, Validation is a working manager position with the primary responsibility of maintaining facilities, equipment, systems, methods and processes in a validated state. The Validation Manager reports to the Site Head (matrixed organization) and is accountable to the regional Validation Head for all functional aspects of the role (Standards, Systems, procedures) to insure regional alignment.

RESPONSIBILITIES:

• Implement and manage an integrated vision for Corporate Validation effort, including a Master Validation Plan consistent with regulatory/compliance requirements and industry standard.
• Working with Development, Facilities, Quality Control, Quality Assurance, IT and Quality Systems, provide input to a comprehensive Master Validation Plan to include but not be limited to:
• Facility qualification/validation
• Equipment qualification/validation
• Test method qualification/validation
• Computer system qualification/validation
• Transport validation
• Cleaning validation
• Aseptic Process Simulations
• Process validation (where applicable)
• Write protocols, execute qualifications and write reports.
• Under guidance from the Site Head of will assure that validation studies are executed in alignment with regional validation policy, standards and procedures.
• Assure Minaris manufacturing site remains in a validated state.
• Assure all changes to the existing facility/equipment/methods/processes are evaluated for impact to the validated state.
• Assure efficiency in the validation effort while not compromising compliance. Such measures include but are not limited to:
• Use of templates for repeating or similar studies
• Reduction in forms/paperwork and the use of primary documents
• Use of vendor-generated qualification documents
• Work closely with Development and other stakeholders to assure well defined, complete and compliant paths for technology transfer.
• Accountable for validation quality metrics (KPIs) to be shared at Quality Council, Management Review, and Site Head.
• Assembling validation related documents; and filing/archiving approved documents.
• Maintaining electronic records.

QUALIFICATIONS:

• Minimum of a Bachelors’ degree in relevant discipline and strong track record (7+ years) in cell therapy, biologics or related field
• 5+ years in management position in a dynamic, fast growth life sciences environment
• 5+ years of Validation (Method, Equipment Qualification, etc.) experience.
• Extensive knowledge regulatory requirements, Good Manufacturing Practices (GMPs) and EU regulations.
• Working knowledge of CDMO business operations and models
• Experience in successfully coordinating across several complex functions to ensure comprehensive and consistent development, sale, delivery and support of products and/or services
• Experience with the preparation and delivery of reports and/or presentations/communications.

COMPETENCIES/CANDIDATE PROFILE:

• Advanced technical understanding of Validation/Qualification Requirements and concepts as the apply to ATMPs, Biologics, and/or Pharmaceuticals
• Creative and compliant thinking for integration of the Quality System
• Advanced knowledge validation instruments such as Kaye Validator, Tachometer, Multimeter …etc.
• Ability to manage ever-changing client and business needs by prioritizing and delegating tasks, resolve inefficiencies, and re-allocate resources within the confines of the Validation department.
• Good inward/outward facing written and oral communication skills
• Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment
• Driven to deliver high quality work in a timely manner and hold other team members accountable to critical timelines and deliverables
• Strong business judgment and acumen
• Analytical and problem-solving skills
• Creative thinking
• Meeting management / facilitation skills / teamwork
• Must have the ability to work in a team-oriented environment.

Supervisory Responsibility

• Ability to perform the job under direct or indirect supervision
• Accountability for allocation of workload to self and subordinates

Minimum Required Training

N/A

WORKING ENVIRONMENT:

• Time flexibility and willing to travel across country and internationally when required.
• May occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen.
• The noise level in the work environment is moderately noisy.

PHYSICAL REQUIREMENTS:

• Ability to work in cleanroom environment for extended periods of time.
• Ability to lift, transfer, or ship validation equipment or related accessories.
• While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands to finger, handle or feel; reach with hands and arms; and talk or hear. The employee is regularly required to climb or balance; stoop, kneel, or crouch. The employee is frequently required to lift and/or move up to 30 pounds and occasionally move tanks up to 300 pounds (with assistance). Non-absorbent laboratory coats are required, as well as latex (or a non-latex substitute) gloves. When working with potentially hazardous materials that may spray, aerosol, or otherwise contact skin or mucous membranes, face shields or goggles must be worn

Direct reports

This position will have direct reports.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

MUST HAVE:

Must come from pharma/biotech/med device/cell therapy/ gene therapy.

Experience with Validation.

Experience with regulatory requirements, Good Manufacturing Practices (GMPs) and EU regulations.

Experience within management position in a dynamic, fast growth life sciences environment.

ADDITIONAL INFORMATION

Shift:  Monday-Friday, Day Shift