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 Process Development Senior Scientist will participate in and lead junior scientists in the daily operations of the process development group. Working in close collaboration with PD leadership and with minimal supervision, the senior scientist will be responsible for the execution and completion of multiple projects involving platform development, optimization, in-process characterization, and tech transfer following appropriate regulatory practices, timelines, documentation, and standard operating procedures. The senior scientist will keep abreast with state-of-the-art technologies and scientific advancements in the field, evaluate scale-up of processes consistent with phase-appropriate guidelines, and participate in discussions on process qualification and strategies for process improvement.

What you will do.

  • 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 
  • Research and development and scale up for the production and purification of gene therapy vectors 
  • Production of gene therapy vectors using adherent and suspension platforms utilizing stacks, shaking flasks, and bioreactors with specific knowledge of process-related and product-related impurities 
  • Growth of cells lines and isolation of mammalian cells; aseptic technique 
  • Optimizing processes/process qualification for Phase 3; determination of CPPs and CQAs using in-process data 
  • Completion of GMP tech transfer and authoring/reviewing Standard Operating Procedures, Technical Reports, Phase III documentation, Risk Assessments, and Equipment Validations 
  • Experimental planning and execution; training of laboratory methods and techniques 
  • Able to work with minimal supervision 
  • Solving and correcting problems by using risk management methods 
  • Performs tasks assigned by leadership as well as assigning tasks to junior staff 
  • Demonstrates discretion, judgment, and personal responsibility to ensure on time, on budget, and quality delivery of a portfolio of gene therapy programs, typically involving multiple platform technologies as well as customized solutions 
  • Demonstrate a high level of integrity 
  • Maintain a positive attitude 
  • Operate within the Quality Management System applicable to the manufacture of phase appropriate material in the clinical manufacturing facility. 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. 
  • 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 degree 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 mammalian cell culture 
  • Experience in chromatography types: affinity, ion exchange, hydrophobic interaction, and multi-modal preferred 
  • Experience in Purification: depth filtration, tangential flow filtration, empty/full separation, chromatography, sterile filtration, and final fill of product 
  • Knowledge of methods for biophysical analysis of biologics, bioanalytics, and/or AAV or lentivirus 
  • Knowledge of Statistical analysis software for analyzing simple and large data sets including DOE software 
  • cGMP Cleanroom experience 
  • Experience in scale-up of processes from flasks to bioreactor preferred 
  • Experience in biologics or gene therapy required 
  • 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 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.