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 for 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.

 

What you will do.

The Senior Specialist, Client QA is responsible for providing QA lead support and oversight of Client Projects from start to finish for GMP Manufacturing of master/working cell banks, drug substance and finished drug product of gene therapy products.  The Client QA Contact serves as the dedicated Client QA Representative and liaisons with the Client and other functions including Project Management, Process & Analytical Development, Manufacturing, Supply Chain, Quality Control and other functions within the Quality Assurance unit. Responsibilities include tracking and reviewing technology transfer documents, specifications, master batch records, change requests, deviations and failure investigations supporting the release of manufactured material.

  • Provides dedicated QA support to client projects and client interactions & meetings
  • Provides quality oversight of GMP operations for the manufacture of master/working cell banks, bulk drug substance and/or final drug product
  • Involved from inception of a client’s project until project closure. Supports Clinical and Commercial QA activities
  • Tracks, documents and presents Quality Metrics presentations for Client Projects (on time batch release, right first time, deviations per batch)
  • Works with clients during initial and subsequent manufacturing campaigns
  • Conducts review of master batch records during Technical Transfer for client processes
  • Supports GMP departments in reviewing and approving deviations and investigations, including root cause analysis, evaluating product/facility impacts, and evaluating effective corrective and preventive actions (CAPAs)
  • Performs risk analysis and mitigation, using available tools such as FMEA, when needed.
  • Work with Manufacturing to address Client comments and/or questions related to batch records
  • Exercise discretion, judgment, and personal responsibility
  • Maintain compliance with applicable regulatory requirements for cellular and gene therapy products
  • Attention to detail in all job functions
  • 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
  • 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.

  • Masters’ degree in a Scientific, Engineering or Biotech field with 4 – 6 years’ experience in Quality Assurance/Quality Control within biologics, biopharmaceuticals, or a regulated industry.
  • Bachelor’s degree in a Scientific, Engineering or Biotech field with 6 - 8 years’ experience in Quality Assurance/Quality Control within biologics, biopharmaceuticals, or a regulated industry.
  • Experience in biologics or gene therapy required
  • Experience in highly regulated field required
  • Experience in CDMO required
  • 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
  • Familiarity with electronic systems, including developing and producing reports using Microsoft products. LIMS, SAP, and Trackwise knowledge preferred.
  • 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 confidential

 

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 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.