Analytical Lab Operations Specialist II

AskBio • Durham, NC

22h • Onsite

About The Position

AskBio Inc., a wholly owned and independently operated subsidiary of Bayer AG, is a fully integrated gene therapy company dedicated to developing life-saving medicines and changing lives. The company maintains a portfolio of clinical programs across a range of neuromuscular, central nervous system, cardiovascular, and metabolic disease indications with a clinical-stage pipeline that includes investigational therapeutics for congestive heart failure, limb-girdle muscular dystrophy, multiple system atrophy, Parkinson’s disease, and Pompe disease. AskBio’s gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive array of capsids and promoters. With global headquarters in Research Triangle Park, North Carolina, and European headquarters in Edinburgh, Scotland, the company has generated hundreds of proprietary capsids and promoters, several of which have entered pre-clinical and clinical testing. 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 Summary The Analytical Lab Operations Specialist II will be responsible for supporting lab operations within the Quality Control and Analytical Development laboratories. This includes management of materials, equipment, third party vendors, budget, documents, and quality events. This position is based on site in Durham, NC and will report to the Lab Operations Manager.

Requirements

• Bachelor’s degree and minimum 2 years of relevant industry experience
• Experience in regulated GMP laboratory within the pharmaceutical or biotech industry
• Experience independently owning and authoring GMP quality events (i.e. deviations, CAPAs, change controls, etc.)
• Strong technical writing skills
• 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/implement organizational systems to improve efficiency and function of working teams

Nice To Haves

• Experience and familiarity with LabVantage LIMS
• Experience with CMMS for equipment maintenance and management

Responsibilities

• Perform tasks associated with maintaining GMP-compliant quality control, analytical development, and stability laboratories as it pertains to sample management, equipment maintenance, material inventory, and other general lab operations needs
• Perform sample management tasks (shipment, receipt, storage) in accordance with applicable regulatory requirements and Standard Operating Procedures (SOPs)
• Schedule equipment maintenance and repair activities and capture documentation of services in the Computer Maintenance Management System (CMMS) in accordance with applicable regulatory requirements and Standard Operating Procedures (SOPs)
• Support management and execution of Operational and Capital Expenditure budgets for Quality Control and Analytical Development Labs
• Support initiation, review, and maintenance of contracts related to Quality Control and Analytical Development lab operations with Legal and IP departments in accordance with applicable regulatory requirements and Standard Operating Procedures (SOPs)
• Act as Single Point of Contact with Third Party vendors, Project Managers, Material Depots and Producers, Material Shippers, and Analytical Development Project Leads to coordinate shipment and receipt of samples and other lab reagents and materials
• Own, initiate, and author deviations, CAPAs, and Change Controls related to all GMP operations and processes
• Author new SOPs and revise existing SOPs as needed
• Support continuous improvement of lab operations procedures by independently identifying process gaps
• Participate in data review processes to ensure accuracy and completeness of information
• Interact with regulatory agencies as the subject matter expert for lab operations related inquiries, including sample management, equipment management and maintenance, and reagent and consumable inventory management
• Strictly adhere to all applicable written SOPs, company policies, and technical guidance documents, both internal and external

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level