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Director, Lab Information Systems

Employer
Kriya Therapeutics
Location
Morrisville, NC
Start date
May 20, 2022

View more

Discipline
Science/R&D, Research, Laboratory
Required Education
Bachelors Degree
Position Type
Contract
Hotbed
Bio NC

COMPANY SUMMARY

Kriya Therapeutics is a transformative gene therapy company with the intent to expand gene therapy to broader disease indications leveraging in house manufacturing capabilities and novel therapeutic designs. 

Our mission is to identify, develop, and bring to market high-impact therapies that have the potential to improve the lives of patients with metabolic and other inflammatory diseases . Our team is made up of leading scientific experts who are passionate about improving patients’ lives and easing the burden of these life-changing disorders for patients. Our team is motivated by the promise of novel drug development and is driven to find more efficient and effective ways to conduct scientific and clinical evaluations that rapidly deliver impactful medicines to patients in need.  

Our leadership team has a track record bringing innovative new therapeutic treatments to a global market, and along with our seasoned board of directors, is fully committed to the responsible pursuit of transformative therapies that significantly impact patient health and wellbeing.

OVERALL SUMMARY 

We are seeking a highly motivated and professionally agile individual to lead the management of laboratory systems as part of Kriya’s Operational Technology team at Kriya.   This individual will own the system lifecycle for laboratory systems in a dynamic FDA regulated startup environment.   Success in this role will require a natural ability to quickly learn and apply new knowledge, the ability to prioritize based on business need, and the willingness to build systems and processes from the ground up for a company in a state of rapid change.  

PRIMARY RESPONSIBILITIES:

  • Participate in the development of an Enterprise Architecture using the ISA95 and ISA88 standards. 
  • Lead the management of key laboratory systems from innovation and early research through GMP manufacturing and commercial activities including LIMS, LES, ELN
  • Lead system integration of lab systems as needed
  • Partner with customer organizations heard and prioritized appropriately. 
  • Lead the validation of requisite systems and serve as an SME to ongoing lifecycle processes such as change management.
  • Owns stewardship of laboratory data to ensure fit within Kriya’s standard data model and ongoing data integrity.
  • Develop scope and manage external service providers and contractors related to laboratory and data initiatives
  • Lead the growth of laboratory and operational technology systems to support data integrity, paperless operations, operational efficiency, and precision execution.
  • Manage areas of responsibility by establishing and continuously improving requisite SOPs
  • Collaborate with quality, clinical lab and development teams to establish and execute processes for our expanding pipelines and pipeline maturity.

EDUCATION REQUIREMENTS:

  • Minimum Bachelor’s Degree

SKILLS REQUIREMENTS:

  • Minimum of 7 years of experience in cGMP and pharmaceuticals/biopharmaceuticals or related industries with a concentration in Operational Technology and Laboratory Automation.
  • 4+ years leadership experience.
  • Experience in Gene Therapy as related to lab systems preferred.
  • Experience with Benchling/LabVantage preferred.
  • A strong customer focus and ability to prioritize and adapt to changing business needs are required.
  • Ability and willingness to both "roll up sleeves" and think strategically related to future growth and expansion.
  • Excellent written and verbal communication skills including the ability to communicate and negotiate across the organization.
  • Experience with software/system selections strongly preferred.
  • Experience building  procedural controls and documentation from the ground up.
  • Ability to leverage industry best practices and previous experiences while remaining creative and innovative.

 

This is an exciting time to participate in the field of gene therapy in general, and to become a part of Kriya Therapeutics’ fast-growing dedicated team. Kriya Therapeutics offers an exciting, meaningful and collaborative fast-paced environment with a foundation of sound and rigorous science. Competitive compensation and benefits package can be expected.

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