LIMS Systems Coordinator

Asklepios BioPharmaceutical, Inc. (AskBio) is a leading, clinical-stage gene therapy company founded in 2001 based on the work of adeno-associated virus (AAV) gene therapy visionary and pioneer, Jude Samulski, PhD. Since that time, our commitment to developing life-saving medicines that can potentially cure genetic diseases has never wavered.

At AskBio, we’ve built a foundation of therapeutic programs, AAV manufacturing and a rich portfolio of patented technology. Our therapeutic focus includes neuromuscular, central nervous system, cardiovascular and metabolic diseases with clinical trials underway for Pompe disease, Parkinson’s disease, and congestive heart failure. Our gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive AAV capsid and promoter library.

We became a wholly-owned, independently operated, subsidiary of Bayer AG in late 2020 as a cornerstone of its newly formed Cell & Gene Therapy (CGT) platform. Our global headquarters is in Research Triangle Park, NC. Additionally, we have significant operations in Philadelphia, PA, Columbus, OH, Scotland, France, and Spain.

Our vision: Pioneering science to create transformative molecular medicines.

Our mission: Lead innovative science and drive clinical outcomes to transform people's lives.

Our principles:

• Advance innovative science by pushing boundaries.
• Bring transformative therapeutics to patients in need.
• Provide an environment for employees to reach their fullest potential.
  
  

Our values:

• Be a Pioneer. We are not afraid of the impossible and to innovate to make gene therapies accessible to those in need.
• Cultivate Collaboration. Strive to be the best teammate, actively listen, openly communicate, and embrace diverse points of view.
• Embrace Responsibility. We are humbled by the enormity of our mission. We hold a relentless commitment to advance science and clinical outcomes for our patients, families, and caregivers.
• Raise the Bar. Continuously drive improvements and efficiencies. Seek and provide constructive feedback. Have a bias for learning and action.
• Act with Uncompromising Integrity. Be honest, transparent, and committed to doing what’s right in every situation. Make clear commitments and follow through.
  
  

Position Overview

The LIMS Systems Coordinator reporting to the Raleigh based Director, Bioanalysis within the Clinical Immunology functional group, will be responsible for development and support of the LabVantage LIMS project within Clinical Immunology as well as the Translational Medicine functional group. The LIMS implementation specialist will be responsible for the deployment of LabVantage LIMS to Translational Medicine including bioanalysis and Clinical Immunology functions to support pre-clinical and clinical studies under GLP/GCLP settings. This position will support the configuration and implementation of LIMS functional modules such as sample, reagent, and instrument management; system interfacing across data, instrument and LIMS; and ELN, etc. This position will be responsible for driving their workload in conjunction with their manager and to ensure compliance with the technical and operational aspects of the LIMS and other QC Systems. They must maintain the controlled state of the system to ensure its continued use is possible. They will be involved in all key aspects of the project including SOP writing, training, and other tasks associated with the LIMS and QC Systems. Candidate must be located in Raleigh-Durham or Philadelphia. Raleigh-Durham candidate preferred. Must be able to travel, domestic and international, up to 20%;subject to additional traveling initially.

Responsibilities

• Collaborate with laboratory personnel to understand their testing needs and workflows.
• Configure the LIMS to meet the specific needs of our clinical environment.
• Interact with Clinical Immunology Lab managers at Philadelphia and the Clinical Immunology/Translational Medicine Laboratory Managers at RTP as well as the assay team leads to understand and capture the sample and assay workflows.
• Work closely with TM and CI functional leads in configuration and deployment of LabVantage LIMS modules such as sample, reagent management and ELN.
• Work closely with IT, CI, QA, and TM functional leads to support data, instrument and LIMS system interfacing across TM and CI functions.
• Liaise with the IT team to address any technical issues related to the LIMS.
• Maintain the Data Integrity of the LIMS and other QC systems in line with 21 CFR Part 11 and other relevant regulatory requirements.
• Develop continuous improvement of LIMS and QC Systems to improve compliance and operational efficiency of clinical sample management including scheduling, receiving, processing and biobanking of patient-derived samples.
• Write/Review Standard Operating Procedures for LIMS and other QC Systems
• Participate in the development, validation, acceptance testing, and implementation of LIMS systems or related enhancements, in partnership with IT and system vendors to meet the needs of various bioanalytical singleplex and multiplex assays.
• Support day to day LIMS activities for method qualification/validation and clinical study support including user training, troubleshooting, study setup, and management of clinical sample reconciliation and data transfers in line with regulatory data standards.
• Work closely with IT and Quality to implement QC systems in Clinical Immunology and Translational Medicine.
• Utilize the change control system to implement changes/improvements including owning, reviewing, assigning actions and impact assessments.
• Routine management and operation of LIMS and QC Systems.
• Support other Clinical Immunology and Translational Medicine quality control initiatives as needed, including but not limited to streamlining documentation, creating / updating SOPs, etc.
  
  

Required Education And Experience

• Master’s degree in Life Sciences, Chemistry, Engineering or related discipline and 3 years’ experience in academic or research laboratory OR Bachelor’s degree in Life Sciences, Chemistry, Engineering or related discipline and 5 years’ experience in academic or research laboratory.
• Experience in lab management in biology, potency, molecular biology, biochemistry, or related field.
• Prior experience as LIMS admin preferably in a cGMP environment.
• Experience in the Pharmaceutical Industry working to cGMP
• Experience or working knowledge in LIMS configuration and implementation in GCP/GCLP environment.
• Ability to travel frequently based on current business needs.
  
  

Preferred Experience And Skills

• Familiarity with LabVantage Software is highly preferred.
• Ability to handle multiple projects/teams simultaneously.
• Ability to work independently in a fast-paced, highly interactive environment with minimal supervision.
• Excellent verbal and written communication skills.
• Ability to build open and collaborative relationships and work effectively as a member of a multi-disciplinary team.
• Excellent self-organization skills with ability to envisage/design
  
  

Asklepios BioPharmaceutical, Inc. (AskBio) is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status or any other protected status prohibited under Federal, State or local laws. All employment decisions are based on valid job‐related requirements. If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in a specific opening by calling us at (919) 561-6210 or sending us an email at careers@askbio.com.

Agencies: Please do not contact any employee at AskBio about this requisition. Any resume submitted by a recruitment agency to any employee at AskBio, through any medium, will be deemed the sole property of AskBio unless the agency was engaged by AskBio Talent Acquisition team to recruit for that position. All agencies must have a prior executed service agreement with AskBio prior to any search engagement. If a candidate who was submitted outside of the AskBio agency process is hired by AskBio, no fee or payment of any kind will be paid to the agency.