Quality Control Analyst II

Benefits

Additional Information

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. The Quality Control Analyst II will be responsible for performing routine testing on analytical methods in the GMP Quality Control laboratories and supporting quality events. This position is based on site in Durham, NC and reports to the Associate Director, Quality Control. Job Responsibilities Perform routine analytical testing including but not limited to cell-based potency assays, ddPCR, qPCR, ELISAs, limit tests using HPLC techniques. Prepares laboratory solutions, maintains cell lines, maintain inventory of materials, and other day to day laboratory activities. Participates in tracking and trending activities for analytical data. Maintains laboratory documentation including logbooks, test forms, LIMS data, and electronic data in a GMP manner. Supports activities for qualification of laboratory equipment and analytical methods. Serve as a trainer for applicable methods for new analysts. Support Quality Control initiatives as needed, including but not limited to streamlining documentation, creating/updating SOPs, etc. Work closely with Analytical Development, Quality Control, Quality Assurance, Production and any other relevant departments. Strictly adheres to all applicable written Standard Operating Procedures (SOPs), company policies, and technical guidance documents, both internal and external. Participates in continuous improvement projects in the AD and QC labs. Revises processes, work instructions, SOPs, forms, protocols, and reports. Own deviations, CAPAs, change controls, and OOS investigations driving them to closure in accordance with internal timelines and external partners. Minimum Requirements Bachelor's degree in a scientific field 2+ years' experience of in cGMP regulated Quality Control laboratory within the pharmaceutical or biotech industry or related field 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 Preferred Education, Experience and Skills Experience with cell-based assays, PCR testing, and/or HPLC testing Experience working within a cGMP Quality Control LIMS system Experience working with deviations, CAPAs, change controls, and /or OOS quality events 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. Al