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 Supervisor of GMP Plasmid Operations is responsible for providing leadership in support all activities within GMP Plasmid manufacturing. The Supervisor will work in close collaboration with Management and the GMP team to develop and coordinate programs to support the overall mission of the facility to provide plasmid raw material for further non-viral and viral manufacturing.  The Supervisor is responsible for ensuring the GMP area delivers all products in a timely, compliant, and fiscally responsible fashion while ensuring all staff working in the manufacturing facility are appropriately trained and operate consistently following appropriate practices, batch records, and Standard Operating Procedures (SOPs) for manufacturing.

 

What you will do.

  • Quality Control Manager, Quality Assurance Manager and staff to cultivate and enact the strategic direction of the Andelyn Plasmid Center including determination of schedule and project timelines/capabilities.
  • Works in close collaboration with GMP Management in the development and oversight of strategic programs and projects within the facility
  • Aids in the development, coordination, and administration of tailored programs for training of all staff to assure the proper adherence to relevant regulations, professional standards, approved SOPs, Master Batch Records, Master Process Plans and research protocols and periodically reports on them
  • Works in close collaboration with GMP facility leadership to ensures the proper function of facilities systems.
  • Directs and assists in daily operational activities related to the GMP Operations of biological products
  • Oversees all GMP resources and supply chain including inventory, production, and facilities, to meet production goals
  • Supports the Development, Quality Control, and the Quality Assurance groups with deviation investigations, OOS results, process change controls, and required process SOP revision and remediation
  • Ensures that personnel training and adherence to appropriate and accurate documentation surrounding GMP activities supporting product quality is maintained
  • Oversees overall staff performance, including hiring, providing feedback, annual performance reviews, and termination if necessary
  • 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
  • Exercise discretion, judgment, and personal responsibility
  • Demonstrate high level of integrity
  • Maintain positive attitude
  • 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
  • Anticipating problems and removing obstacles to enable staff to perform tasks as assigned
  • Work to specific measurable objectives requiring operational planning skill with little direct supervision
  • Cultivate a diverse and collaborative team environment. Utilizes clear and concise communication to deliver high productivity and contribution to the success of department goals
  • Developing and enforcing procedures and controls
  • Approval of procedures established by junior staff
  • Has budgetary responsibility
  • Moderate travel required
  • Frequent involvement in audits
  • Frequent involvement in customer relations
  • Significant responsibility for inspection outcomes
  • Responsible for hiring, development and related personnel processes
  • Mentoring and professional development of staff
  • Exercise crucial people skills
  • Ability to manage and influence people in direct and lateral support structure
  • Have significant latitude for making decisions for their operational or functional unit
  • Drives timelines and development through broad influence
  • Minimal interaction with legal services
  • Other duties as assigned

 

What you bring to the team.

  • Knowledge of GMP, GLP, or other Federal Regulations.
  • Must possess relevant four-year degree OR relevant Masters OR relevant PhD, background in the life sciences, biotechnology or gene therapy industries preferred
  • Working knowledge of team function within the organization
  • First-level leadership.  Coordinates and leads daily team activities.  May spend a portion of time performing the work of those they supervise
  • Prior supervisory experience is preferred
  • 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.