GMP Quality Control Specialist II - Starting Materials

Andelyn Biosciences is a biopharmaceutical Contract Development and Manufacturing Organization (CDMO) that specializes in advancing novel gene therapies from concept to commercialization.Located in Columbus, OH , the company operates out of the Andelyn Corporate Center (ACC) for clinical and commercial cGMP manufacturing of viral vectors and plasmids and the Andelyn Development Center (ADC) for preclinical non-cGMP activities. Our Values are founded in our origin story. The name “Andelyn” is a hybrid of two gene therapy patients who participated in pivotal Phase I clinical trials at Nationwide Children’s Hospital. Andrew received the first U.S. investigational gene therapy for Duchenne muscular dystrophy in 2006. Evelyn received experimental gene therapy for spinal muscular atrophy in 2015. “Andelyn” combines their names to represent all the families who have courageously participated in the research that makes today’s gene therapies possible. Through this journey, we have been able to accelerate thedevelopmentand manufacturing of innovative therapies to bring more treatments to more patients. We are Turning Hope into Reality™ through our ACCTS ions. A CCOUNTABLE in our actions. C OMPASSIONATE in our thinking. T RUSTWORTHY in our communications. S UPPORTIVE of one another. Employees are expected to perform the following essential functions under the framework of our ACCTS ions. What you will do. The GMP Quality Control (QC) Specialist II SM will perform assigned tasks to support the daily operations of QC Starting Materials. The primary objective is to ensure that all activities within QC Starting Materials comply with the requisite regulations (21 CFR Part 211 Subpart I, 21 CFR Part 11, et. al.). Working in close collaboration with QC Management, and senior QC staff, the Specialist II SM will aid all day-to-day Starting Material operations, including project and timeline management, inspection and sampling of raw materials in an ISO classified clean room space, testing and release of raw materials, assisting with laboratory investigations, material release specifications, SOP generation and revision. The Specialist II SM will aid QC Management in ensuring that their assigned tasks are performed by following appropriate regulatory practices, and Standard Operating Procedures (SOPs) for GMP. Operate within the Quality Management System applicable to the manufacture of cGMP material Maintain compliance with applicable regulatory requirements for cellular and gene therapy products Works in close collaboration with the QC Management and senior QC staff to cultivate and enact strategic direction of QC Starting Materials including determination of schedule and project timelines/capabilities Writes and reviews the creation and maintenance of Standard Operating Procedures that affect the conduct of operations within QC Starting Materials (equipment and process SOPs) and ensures that they are written with proper scope, detail, and format to meet FDA guidance Provides QC Management with all laboratory data generated from QC Starting Materials tasks, including material inspection, sampling, testing, and release. Manages and reviews the compilation of all data and ensures its correctness Supporting the proper operation, calibration, validation, cleaning, and maintenance of QC equipment and systems including the weigh and dispense suite Assists in purchasing, shipment, and communications with external QC Starting Materials activities, including applicable vendors and Contract Testing Laboratories to obtain needed Documentation, i.e. COA, COC, testing results, in coordination with QC Supervisor Assists QC Management with the management of the laboratory investigations, QC portion of deviation investigations, OOS results, process change controls, material release specifications, and required process SOP revision and remediation Works in close collaboration with the QC Management and senior QC staff to ensure continuous improvement objectives are identified and met using metrics and other statistical means Works in close collaboration with the QC Management and senior QC staff to ensure new projects and technologies are sought for incorporation into QC Starting Materials Respond to, and act on, alarm notifications from the applicable monitoring system(s) for laboratory temperature-controlled storage units that occur during the assigned period of responsibility Exercise discretion, judgment, and personal responsibility Demonstrate a high level of integrity Attention to detail in all job functions Operates in alignment with established policies, procedures, and techniques, requiring relevant training, practical experience, or a working knowledge of the tasks involved. Identifies problems and proposes solutions. Performs tasks as assigned by leadership Ability to work with some independence based on applicable experience Works in a diverse and collaborative team environment utilizing clear communication to deliver high productivity and contributes to the success of team and goals Documentation of all activities performed according to SOPs Make decisions based on established procedures Nominal fiscal responsibility May require some travel Limited involvement in audits Limited involvement in customer relations Limited responsibility for inspection outcomes Other duties as assigned What you bring to the team. Must possess relevant four-year degree OR relevant master’s OR relevant Ph.D., background in the life sciences, biotechnology, or gene therapy industries preferred Three years relevant (w/4 YR deg) OR no experience with (w/Masters) Experience in biologics or gene therapy preferred Experience in highly regulated field preferred Excellent communication, organization, and project management skills with the ability to manage multiple projects efficiently and adjust as priorities change Must be skilled in Microsoft Office (PowerPoint, Excel, Word) including data interpretation and reporting Ability to work independently as well as collaboratively in a diverse and inclusive work environment Must possess a client-focused mindset in daily tasks Must possess prior experience handling confidential information and the ability to maintain confidentiality What you can expect when working at Andelyn. Pride in contributing to the development and manufacturing of lifesaving therapies. The invaluable experience of being a part of building the foundation of a new organization. The opportunity to collaborate with experts who have over 10 years in the gene therapy field. Competitive compensation Eligible on day one for medical, dental, and vision insurance plans with basic vision at 100% company-paid 160 hours of Paid Time Off annually 11 Company Paid Holidays plus 2 floating holidays annually. Company Paid Life Insurance 401(k) Match Company Paid short and long-term disability. 4 weeks of Paid Parental Leave for birth and adoption Adoption Assistance Tuition Reimbursement and Student Loan Repayment Assistance Company Paid LinkedIn Learning access. Employee Assistance Programs Flexible work options (role specific) Andelyn Biosciences embraces diversity and is an equal opportunity employer and does not discriminate based on race, religion, national origin, gender, gender identity, genetic information, sexual orientation, protected veteran status, disability, age, or another legally protected status. As an organization, we are committed to creating an environment where everyone ACCTS. #J-18808-Ljbffr Valid8 Financial, Inc.