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 Overview

The Senior Quality Control Associate, Clinical Immunology reporting to a Sr. Director within Clinical Immunology, will be responsible for Quality Control activities within the Clinical Immunology functional group at both the Discovery 1 laboratory located in RTP and the laboratory at the Philadelphia site. This position will be responsible for building and maintaining Quality Control practices in compliance with local procedures and safety regulations.

Responsibilities

• Review documentation of all clinical samples received, processed, and biobanked using LIMS and controlled documents according to ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available).

• Review documentation of outgoing and incoming sample shipments, including sample inventory reconciliation according to ALCOA+ principles.

• Perform thorough peer review according to ALCOA+ principles to ensure accuracy of raw data, calculations, and trending on technical data generated by the antibody assay team including NAb and TAb assays.

• Perform thorough peer review to ensure accuracy of raw data, calculations, and trending on technical data generated by the ELISPOT team at both RTP and Philadelphia locations.

• QC review of assay qualification/ validation plans, data and reports according to ALCOA+ principles.

• QC review of regular electronic data uploads to data management portals.

• Conduct internal audits of studies, reports, records, and data to ensure compliance with ALCOA+.

• Detect Quality Issues and support appropriate corrective and preventative actions.

• Assist with improvement initiatives intended to improve quality, study compliance, project data, and reports.

• Contribute to the development, implementation, and maintenance of Standard Operating Procedures.

• Support the coordination and management of regulatory agency inspections, parent company audits, etc.

• Participate in meetings as a quality control representative as requested.

• Ensure the specified laboratory at Discovery 1 is in compliance with CLIA regulations.

• QC additional lab operations for compliance with GLP/GcLP compliance (e.g. equipment and reagent logbooks).

• Manage corrective and preventative action (CAPA) process and lead continuous improvement activities.

• Assist with training of CI staff on aspects of the Quality Management System and regulations that are relevant to their role.

• Maintain a close liaison with Quality Assurance to facilitate their support of Clinical Immunology activities.

• Travel regularly between Philadelphia and RTP sites as needed to perform direct oversight of physical processes such as paper documentation and laboratory equipment.

• Strictly adhere to all applicable written Standard Operating Procedures (SOPs), company policies, and technical guidance documents, both internal and external.

• Partner with laboratory staff to create efficient processes for documentation and data flow

Required Education and Experience

• Bachelors in a relevant scientific field and 5 years of work experience or Masters and 2 years of relevant work experience, or 9 years of relevant work experience

• 5+ years’ QC experience in a GLP/GCLP laboratory within the pharmaceutical or biotech industry or related field

• Minimum of one year of experience writing SOP in a research environment

• Previous experience with antibody and/or cell-based assays: NAb/TAb/ELISPOT highly desirable

• Knowledge of industry best practices and regulatory requirements (Good Clinical Laboratory Practice, Good Laboratory Practice, Good Clinical Practices, CLIA and a solid understanding of Good Documentation Practice, 21 CFR Part 11, and laboratory standards relevant to clinical and preclinical laboratory research

• Strong collaborative skills. Must be able to effectively collaborate cross-functionally with peers, scientific and technical staff; and be comfortable working in a matrixed team

Preferred Experience and 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

• Experience with LIMS systems, especially LabVantage, is highly desirable

AskBio 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.