Sterility Assurance Supervisor

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 Supervisor of Sterility Assurance will be responsible for quality assurance oversight of aseptic processing programs, contamination control strategy, and microbial control policies for Operations. This individual should be able to work independently with little direction to develop and implement policies and procedures and related completed media fill/APS documentation, cleanroom qualifications, environmental excursions SME, deviations and sterility failures. This will include contamination analysis, development of contamination control plans across numerous programs from unit level up to integration and test, coordination of contamination control design across the in-house team and subcontracts.

• 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.
• Develop and Lead Sterility Assurance Council
• Provide oversight and sterility assurance expertise to Operations to assure aseptic processing meets US and international aseptic processing requirements.
• Assesses facility and quality systems’ state of compliance with internal requirements and appropriate regulations and participates in the development of action plans to correct deficiencies and improve quality processes.
• Provides expertise to support environmental excursions, deviations, CAPAs and complaints related to aseptic processing.
• Demonstrated experience writing contamination control plans and implementation
• Working knowledge of the manufacture of advanced therapies medicinal products
• Working knowledge of FDA and EMA requirements as they pertain to contamination control
• Hands-on experience in contamination control
• Understanding of principles and methods for contamination control in cleanroom environments
• Knowledge and experience with Grade A to Grade D Cleanrooms
• Ability to provide concurrent support to multiple programs
• Familiarity with ISO cleanroom requirements and methods of operation
• Prepares project plans, write status reports, and gives oral presentations to customers and management.
• Other duties as assigned

What you bring to the team.

• Four-year degree OR relevant Masters OR relevant Ph.D., background in the life sciences, biotechnology, or gene therapy industries preferred, not required.
• Prior experience in contamination control/sterility assurance
• Broad knowledge of the field with proven leadership skills
• Prior management experience is required
• Excellent communication, organization, and project management skills with the ability to manage multiple projects efficiently and adjust as priorities change
• Must be highly 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.