Overview of Andelyn Biosciences

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 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.

 

What you will do.

The GMP Quality Control (QC) Supervisor will provide daily control of the GMP QC laboratory. The primary objective is to ensure that all activities within the GMP QC laboratory facility comply with the requisite regulations (21 CFR Part 211 Subpart I, 21 CFR Part 11, et. al.). Working in close collaboration with the QC Management will oversee all day-to-day lab operations, including project and timeline management, personnel, and lab facility management. The QC Supervisor will ensure all staff working in the QC laboratory are properly trained and operate consistently following appropriate regulatory practices, analytical methods, and Standard Operating Procedures (SOPs) for GMP operations.

 

  • Works in close collaboration with the QC Management to cultivate and enact strategic direction of the QC Lab area including determination of schedule and project timelines/capabilities
  • Oversees the writing and execution of analytical test methods and testing protocols in coordination with QC Management to ensure proper procedures are in place for QC Lab operations.
  • Directs and reviews, in coordination with QC Management, the creation, and maintenance of Standard Operating Procedures that affect the conduct of operations within the QC laboratory (equipment and process SOPs) and ensures that they are written with proper scope, detail, and format to meet FDA guidance
  • Acts as a central point of control for all laboratory data generated from QC laboratory tasks, including in[1]process, release, and stability testing. Manages and reviews the compilation of all data, ensures its correctness, and report findings to GMP management staff
  • Supervises / coordinates the proper operation, calibration, validation, cleaning, and maintenance of QC laboratory equipment and systems as specified in methods
  • Works in coordination with QC Management and QC Scientists and Project Managers in management of laboratory investigations, the QC portion of deviation investigations, OOS results, process change controls, and required process SOP revision and remediation
  • Responsible for GMP Quality Control scientific staff performance, including hiring, providing feedback, annual performance reviews, and termination if necessary
  • Works in close collaboration with the QC Management to ensure continuous improvement objectives are identified and met using metrics and other statistical means
  • Works in close collaboration with the QC Management to ensure new projects and technologies are sought for incorporation into the QC Laboratory. Exercise discretion, judgment, and personal responsibility
  • Demonstrate a high level of integrity
  • Maintain a positive attitude
  • 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.
  • Anticipating problems and removing obstacles to enable staff to perform tasks as assigned
  • Work to specific measurable objectives requiring operational planning skills 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 the 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.

  • 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
  • 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 that 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 Paid Holidays plus 2 floating holidays annually.
  • Company-paid 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.