Environmental Monitoring Technician

Andelyn Biosciences Job Opportunity

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 Pioneering Solutions that Turn Hope Into Reality™ through our ACCTS ions.

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 ACCTS ions.

What you will do.

The Environmental Condition Team is responsible for the activities associated with the manufacture of safe, effective pharmaceuticals in accordance with company SOPs, and policies. The Environmental Monitoring Team works in concert with and assists the manufacturing department and plays a critical role in ensuring environmental control of the cleanroom. The Environmental Monitoring Technician position is primarily responsible for performing environmental monitoring activities including air, surface, and personnel monitoring within the cleanroom. In addition, to sampling critical utilities throughout the GMP facility.

• Conduct environmental monitoring activities including air (Viable and Non-viable), surface, and personnel inside the cleanrooms.
• Assist with execution of EMPQ activities to support establishment of environmental monitoring program.
• Perform routine environmental monitoring and utilities sampling (water systems and Compressed Air/Gas).
• Maintain accurate records of work performed in LIMS and Laboratory systems according to Good Documentation Practices, SOPs, and policies.
• Assist with data entry for analysis and trending.
• Record results and report deviations from out-of-specification results.
• Communicate any discrepancies or deviations to supervision/management upon discovery.
• Ensure all work is performed and documented in accordance with existing company policies, procedures, Current Good Manufacturing Practices, and health and safety requirements.
• Plan daily workload to meet requirements.
• Must complete and maintain gowning qualifications to work in a cleanroom.
• Maintains compliance with all required SOPs and Policies.
• Perform any other duties/tasks as assigned by management.

What you bring to the team.

• Must have associate's degree and 6 months of related GxP laboratory experience OR Bachelor's degree, a background in the life sciences, biotechnology, or gene therapy industries preferred.
• No minimum experience.
• Experience gowing within a GMP facility is preferred.
• Experience in documentation preferred.
• Experience in highly regulated fields preferred.
• Excellent communication, organization, and project management skills with the ability to manage multiple projects efficiently and adjust as priorities change.
• Must be computer literate in Microsoft Office (PowerPoint, Excel, Word)
• 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)

The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification. It is not to be construed as an exhaustive list of duties performed by the individual so classified, nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under his/her supervision.

Andelyn Biosciences is committed to a diverse and inclusive workplace. Andelyn is an equal opportunity employer and does not discriminate based on race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or another legally protected status.