Sterility Assurance Supervisor

Andelyn Biosciences, Inc•Columbus, OH

11h

About The Position

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.

Requirements

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.
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

Responsibilities

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.
Prepares project plans, write status reports, and gives oral presentations to customers and management.
Other duties as assigned

Benefits

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)