Overview
Training Administrator Jobs in Remote at Element Materials Technology
Overview of Andelyn Biosciences
Andelyn Biosciences is a biopharmaceutical Contract Development and Manufacturing Organization (CDMO) focused on advancing novel gene therapies from concept to commercialization. Located in the heart of Columbus, OH, the company has expanded to three buildings with more than 250,000 combined square feet of space. The Andelyn Corporate Center (ACC) is dedicated to cGMP manufacturing, the Andelyn Development Center (ADC) for preclinical non-cGMP activities, and the Andelyn Plasmid Center (APC) for research and cGMP plasmid production.
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 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.
The Senior Specialist, QA, Operations is an individual contributor role and provides compliance and quality assurance support to the manufacturing operations. This position will report to the QA Supervisor and will work closely with the manufacturing operations staff and will support internal Quality Assurance functions focused on GMP operations and associated quality systems, including change controls and internal process verification
What you will do.
Operate within the Quality Management System applicable to the manufacture of phase appropriate material in the manufacturing operations
Works closely with Operations colleagues to support activities that ensure control of clinical manufacturing and the facility
Support Product Release to meet Target Disposition Date
Review and approve master and executed batch records
Observe manufacturing activities to support the implementation of best practices and improvements.
Author and review procedures, as assigned
Ensures that documentation is maintained following internal procedures and regulatory requirements
Supports and maintains an environment that fosters communication and teamwork within Quality Assurance and related departments
Work with Manufacturing to address Client comments and/or questions related to batch records
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
Operates in alignment with established policies, procedures, and techniques, requiring relevant training, practical experience, or a working knowledge of the tasks involved.
Solving, correcting, preventing problems, and performs tasks as assigned by leadership, as well as assigning tasks to junior staff
Work to specific measurable objectives requiring operational planning skills with little direct supervision Leads and supports a diverse and collaborative team environment.
Utilizes clear and concise communication to deliver high productivity and contribution to the success of team and goals
Documentation of all activities performed according to SOPs
Make decisions based on established procedures
Has fiscal responsibility
Infrequent travel required
Moderate involvement in audits
Moderate involvement in customer relations
Moderate responsibility for inspection outcomes
Influences hiring, development, and related personnel processes
Mentoring and professional development of staff
Other duties as assigned
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 years relevant (w/4 YR deg) OR two years (w/Masters)
Experience in biologics or gene therapy required
Experience in highly regulated field preferred
Proficient knowledge of cGMP regulations and guidelines including but not limited to U.S. Code of Federal Regulations 21 CFR Part 11 and Part 210 & 211, European Directives, ICH guidelines, and cGMP regulations
Experience in commercial and clinical GMP production and ability to provide QA support for both
Experience with aseptic manufacturing operations 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 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.
Title: Training Administrator
Company: Element Materials Technology
Location: Remote
