Environmental Monitoring and Sterility Assurance Manager at Andelyn Biosciences, Inc

Columbus, Ohio, United States -

Full Time

Start Date

Immediate

Expiry Date

14 Oct, 26

Salary

0.0

Posted On

16 Jul, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Environmental Monitoring, Sterility Assurance, Aseptic Processing, Contamination Control Strategy, GMP Compliance, Trend Analysis, Quality Event Investigation, CAPA Management, Technical Writing, People Management, Regulatory Compliance, Microbiology, Aseptic Process Validation, Statistical Evaluation, Project Planning, Audit Management

Industry

Biotechnology Research

Description

Overview of Andelyn Biosciences 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. What you will do. The Environmental Monitoring and Sterility Assurance Manager will complete the principal duties and responsibilities outlined below. Working in collaboration with leadership and senior staff, the Manager will plan and oversee the development, implementation, execution of critical cleanroom sterility assurance strategies, aseptic processing programs, contamination control strategy, and microbial control policies for Operations. Activities may include oversight of routine environmental monitoring (EM) program, approval of EM trending reports, investigation of quality events, development, and management of corrective action / preventative action (CAPA), media fill/APS documentation, cleanroom qualifications, deviations and sterility failures, oversight of project timelines/tasks, approval of technical and procedural documents, as well training and mentoring junior staff. This will include contamination analysis, development of contamination control plans across numerous programs from unit level up to integration and test, and coordination of contamination control design. The Manager will support efforts to deliver all products in a timely, compliant, and fiscally responsible fashion. * Developing and enforcing procedures and controls related to environmental monitoring and associated reporting and trending practices – may include, but is not limited to, standard operating procedures, work instructions, technical protocols, technical reports * Responsibility for EM sampling scheduling to support manufacturing, meet project timelines and ensure compliance with policies and procedures * Provide strategic plan and expertise for the development and implementation of the site Sterility Assurance Program * Develop, document and manage microbial control strategy for production processes from incoming raw materials through final product release * Oversee, Manage and support the execution of the contamination control strategy for the facility including, but not limited to aseptic process validation, facility design and modification, gowning, critical utilities, and EMPQs * Generates, owns, and/or supports change controls, deviations, CAPAs within the eQMS system. * Identify, review and approve an investigation of adverse EM Excursions/trends and participate in cross-functional quality event investigations * Analyze data summaries and perform statistical evaluations for quarterly EM trending reporting * Develop and Lead Sterility Assurance Council. Present quarterly EM trending findings to Andelyn Quality Council and Contamination Control Committee * Prepares project plans, writes status reports, and gives oral presentations to customers and management * Regularly monitor applicable information published by the US FDA, EMA, PIC/S, Annex 1, pharmaceutical manufacturing, and laboratory technology organizations for the purpose of review/incorporation of latest requirements and guidelines into routine operations * Responsible for hiring, development, cultivate a diverse and collaborative team environment * Utilizes clear and concise communication to deliver high productivity and contribution to the success of department goals * Develop, implement, and drive continuous improvement initiatives within the Sterility Assurance and Environmental Monitoring program * Frequent involvement and ultimate responsibility in audits and customer relations * Operate within the Quality Management System applicable to the manufacture of phase-appropriate material in the CMF * Maintain compliance with applicable regulatory requirements for cellular and gene therapy products * Demonstrate a high level of integrity and attention to detail in all job functions * Maintain a positive attitude * Exercise crucial people skills * Other duties as assigned What you bring to the team. * Requires a bachelor’s degree in microbiology, Biology, Molecular Cellular Biology or related field * Requires eight years of relevant experience in pharmaceutical environmental monitoring/microbiology * Requires 3 to 5 years of experience in a leadership role * Excellent knowledge of GMPs, FDA, EU and ISO standards/regulations * Excellent knowledge of compendial procedures and guidance documents (i.e., USP, PIC/S, Annex 1) * Experience in performing trend analysis * Strong understanding of aseptic manufacturing, microbial environmental monitoring and Sterility Assurance * Experience with quality event investigation is required * Excellent communication and presentation skills * Strong organizational and prioritization capabilities * Skilled in technical writing and analytical problem-solving 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.

Responsibilities

The Manager will oversee cleanroom sterility assurance strategies, environmental monitoring programs, and contamination control policies for biopharmaceutical operations. Key duties include managing quality events, approving technical documents, and leading the Sterility Assurance Council to ensure compliant product delivery.