Senior Validation Specialist, Aseptic Process Simulation at Andelyn Biosciences, Inc

Columbus, Ohio, United States -

Full Time

Start Date

Immediate

Expiry Date

25 Aug, 26

Salary

0.0

Posted On

27 May, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Aseptic Process Simulation, Media Fill, Process Validation, Contamination Control, Risk Analysis, Regulatory Compliance, Sterilization, Aseptic Handling, Isolator Technology, Project Management, Data Interpretation, Deviation Management, Root Cause Analysis, Microsoft Office, PPQ, CPV

Industry

Description

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 the development and manufacturing of innovative therapies to bring more treatments to more patients. We are Turning Hope Into Reality™ through our ACCTSions. ACCOUNTABLE in our actions. CURIOUS to discover. COMPASSIONATE in our thinking. TRUSTWORTHY in our communications. SUPPORTIVE of one another. Employees are expected to perform the following essential functions under the framework of our ACCTSions. As Senior Validation Specialist, Aseptic Process Simulation, you will own, develop, maintain and deploy the overarching strategy for the execution, control, and continuous improvement of the aseptic process simulation (Media Fill) program. The Senior Validation Specialist will define the framework for worst-case scenarios, validation studies and evaluation criteria, and take responsibility for the methodology, planning, execution, and analysis of Media Fills. The role works closely with customers in Manufacturing and Quality Assurance to enable successful, consistent and reliable execution of all media fill activities, and also serve as the main point of contact for all relevant interfaces with Regulatory Authorities. In addition, the role will support design, implementation, and execution of process validation activities to ensure the compliance, quality, and efficacy of our manufacturing processes. * Develop a robust, comprehensive Aseptic Process Simulation (Media Fill) strategy that includes worst-case scenarios rooted in sound, risk-based methodology. * Define simulation parameters in accordance with current regulatory guidelines including specify routine and non-routine interventions (e.g. personnel changes, machine stops, interruptions) during simulations. * Manage, oversee and direct Media Fill simulations to ensure all documentation and end-to-end execution is carried out on time, in full. * Conduct deviation management: Ensure systematic root cause analyses are performed when necessary, assess and escalate issues when action/warning limits are exceeded, and initiate revalidation if applicable. * Collaborates closely with Manufacturing, Quality Assurance, Engineering, and MS&T * Collaborates with Microbiology and QC to integrate Environmental Monitoring (EM) data and strategy into the APS program * Ensure GMP-compliant validation practices according to PQS, EU GMP Annex 1, and international guidelines. * Prepare for inspections and audits, train personnel, and support regulatory inspections, responses and submissions * Develop, Implement, and Maintain the Process Performance Qualification (PPQ) and Continued Process Validation (CPV) programs, including development of related procedures, templates, work instructions, and associated documentation. * Conduct hands-on validation activities, such as protocol generation, execution, data analysis, and report writing. * Exercise discretion, judgment, and personal responsibility * Demonstrate a high level of integrity * Maintain a positive attitude * Maintain compliance with applicable regulatory requirements for cellular and gene therapy products * Attention to detail in all job functions * Performs in accordance with established policies, procedures, and techniques and requires training common experience or working knowledge related to the tasks performed * Solving, correcting, preventing problems, and performing tasks as assigned by leadership * Work to specific measurable objectives requiring operational planning skills with little direct supervision * Develop the scope and devise an approach for assigned writing assignments * Manage multiple writing assignments or investigations at any given time * Make decisions based on established procedures * Moderate involvement in audits * Moderate involvement in customer relations * Moderate responsibility for inspection outcomes 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 * Five to eight years of relevant experience required, including 3 years of experience with commercial drug product filling. Direct experience with agency inspections a plus. * You must possess in-depth expertise in aseptic process simulation (Media Fill), process validation, contamination control, and risk analysis. * Familiarity with regulatory guidelines (ISO 13408-1, PIC/S, FDA, EU GMP Annex 1) * Strong foundation in sterilization, first air and aseptic handling principles * Experience in biologics or gene therapy manufacturing required, including experience with isolator technology or other closed system processing. * 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. * The pride of contributing to the development and manufacturing of life-saving therapies * The invaluable experience of being a part of building the foundation of a new organization. * The opportunity to work alongside experts who have over 10 years in the gene therapy field. * Competitive compensation * Eligible 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.

Responsibilities

The role is responsible for developing and executing the overarching strategy for the Aseptic Process Simulation (Media Fill) program, including defining worst-case scenarios and validation criteria. Additionally, the specialist will manage Process Performance Qualification (PPQ) and Continued Process Validation (CPV) programs to ensure manufacturing compliance and quality.