Specialist II - Technical Training - Andelyn Biosciences, Inc

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.

As a Specialist II - Technical Training you will be who is responsible for administrative management and oversight of the site’s training documentation and LMS. Work cross-functionally to develop, improve, and assign department curriculum based on the changing needs of the site. This individual will be accountable for driving results in a fast-paced environment. The Technical Trainer is an experienced learning and development professional with technical training and cGMP expertise.

What you will do.

• Work cross-functionally to develop, improve, and assign department curriculum based on the changing needs of the site
• Create, implement, and maintain a site Train the Trainer program
• Serve as the Admin for ComplianceWire (LMS) and maintain employee training files/database.
• Processes training files by reviewing records for deficiencies ensuring the documentation is in accordance with regulatory requirements, and resolving discrepancies
• Work cross-functionally to determine the department’s training needs, and develop effective, modular-based training (e.g. curriculums, Instructor-led Training and On-the-Job training);
• Participate in the implementation of “Smart” curriculums in LMS.
• Support departments in creating, implementing, and maintaining site quizzes within LMS.
• Support management by creating and reporting key training metrics (e.g. Monthly and Quarterly Management reports, weekly overdue/coming due assessments);
• Support and participates in internal and external audits.
• Perform focused new hire and refresher training of current employees (performed individually, virtually, and in group settings);
• Demonstrates emerging skills in influencing others and ability to develop innovative ideas for solving problems.
• Exercise discretion, judgment, and personal responsibility
• Respond to, and take action from, alarm notifications from the applicable monitoring system(s) for laboratory temperature-controlled storage units that occur at any point during the assigned period of responsibility
• Maintain compliance with applicable regulatory requirements for cellular and gene therapy products
• Attention to detail in all job functions
• Performs in accordance with established policies, procedures, and techniques and requires training common experience, or working knowledge related to the tasks performed
• Identifies problems and proposes solutions.  Performs tasks as assigned by leadership
• Ability to work with some independence based on applicable experience
• Documentation of all activities performed according to SOPs
• Other duties as assigned

What you bring to the team.

• Must possess relevant four-year degree OR relevant Master’s OR relevant PhD, background in the life sciences, biotechnology or gene therapy industries preferred
• Three years relevant (w/4 YR deg) OR no experience with (w/Masters)
• Experience in biologics or gene therapy preferred
• Experience in highly regulated field preferred
• Excellent communication, organization, and project management skills with the ability to manage multiple projects efficiently and adjust as priorities change
• Must be 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.