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 Turning 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 Associate Director, Quality Control Microbiology (Environmental Monitoring and Microbiological Safety Testing) owns/supports the strategy, execution, and governance of microbiological environmental monitoring and safety testing programs supporting pre-clinical, clinical and commercial GMP manufacturing. You will lead teams responsible for safety testing (endotoxin, bioburden, sterility, mycoplasma) and environmental/utility monitoring. You will partner closely with Sterility Assurance to support and execute the site Contamination Control Strategy (CCS) and ensure sustained inspection readiness. You will provide technical leadership, drive high-quality investigations, and ensure microbiology programs protect product quality and patient safety.

Program Leadership and Strategy

  • Lead QC Microbiology functions including environmental monitoring and microbiological safety testing (endotoxin, bioburden, sterility, mycoplasma, gram stain).
  • Establish technical direction, performance expectations, and quality goals for QC Microbiology.
  • Ensure microbiology programs are phase appropriate, risk based, and aligned with regulatory and client expectations.
  • Drive continuous improvement initiatives that increase right-first-time (RFT) performance, reduce rework, and strengthen inspection readiness.

Environmental Monitoring and Safety Testing Oversight

  • Own the EM program for classified and controlled areas, including sampling plans, limits, scheduling, training, execution oversight, and trending.
  • Own microbiological safety testing strategy and execution for in-process, release, stability, validation, and client-specific testing requirements.
  • Ensure method suitability, verification/qualification, and growth promotion for all applicable methods.
  • Ensure timely and accurate reporting of microbiology results to support client timelines and product disposition.

Contamination Control Strategy and Sterility Assurance Support

  • Partner with Sterility Assurance to support development, maintenance, and execution of the site Contamination Control Strategy (CCS).
  • Provide microbiology SME input to contamination control risk assessments, aseptic practices, cleaning and disinfection programs, and environmental controls.
  • Use EM and microbiology data to identify contamination risks and drive preventive actions impacting client programs.

Investigations, Deviations, and CAPA

  • Lead or approve EM excursions and microbiological OOS/OOT/invalid results.
  • Ensure investigations are timely, scientifically sound, and include robust root cause analysis and product impact assessments.
  • Communicate investigation status, risk assessments, and conclusions to internal stakeholders and clients as appropriate.
  • Own microbiology related CAPAs and verify effectiveness.
  • Identify systemic issues and lead improvement initiatives to prevent recurrence.

Quality Systems and Compliance

  • Author, review, and approve SOPs, protocols, and forms related to microbiology testing and EM.
  • Ensure data integrity, ALCOA++ documentation practices, and GMP data review.
  • Support and host regulatory and client inspections as microbiology SME.
  • Support client audits, technical due diligence, and responses to client quality questionnaires.

People Leadership and Operations

  • Lead and develop managers, supervisors, and technical staff within QC Microbiology.
  • Ensure staffing models, training, and qualification programs support operational demand and client commitments.
  • Drive lab operational excellence, including capacity planning, sample flow, and equipment readiness.
  • Foster a culture of continuous improvement, accountability, and high-quality execution.

Continuous Improvement and Cost Stewardship

  • Identify and implement opportunities to improve efficiency, reduce cycle time, and eliminate non-value-added activities.
  • Apply lean and risk-based approaches to optimize EM and microbiology testing processes.
  • Own the QC Microbiology departmental budget, including labor, consumables, contracts, and capital planning.
  • Develop and manage budget forecasts and spending plans to deliver low-cost, high-quality output.
  • Evaluate make-versus-buy decisions, vendor performance, and automation opportunities to improve cost and capacity.

Cross-Functional and Client Collaboration

  • Partner with Manufacturing, QA, Sterility Assurance, MSAT, Validation, and Engineering.
  • Serve as primary microbiology point of contact for client technical discussions related to EM, microbiological safety testing, and contamination control.
  • Provide microbiology input to change controls, deviations, facility modifications, and new product introductions that impact client programs.
  • Support product disposition and client communications related to microbiological quality.

 

 

What you bring to the team.

 

  • Bachelor’s degree in Microbiology, Biology, Biochemistry, or related life sciences discipline required;
  • Minimum 8–10 years of progressive GMP experience in QC Microbiology and/or environmental monitoring within biologics, cell and gene therapy, or sterile pharmaceutical manufacturing.
  • Minimum 5 years of people management experience, including direct management of managers and/or supervisors (second-level manager).
  • Demonstrated technical expertise in microbiological safety testing, including endotoxin, bioburden, sterility, mycoplasma, gram stain, microbial identification, growth promotion, and environmental monitoring.
  • Broad understanding of microbiology laboratory techniques and the scientific basis of analyses performed.
  • Strong working knowledge of cGMP regulations and guidance, including FDA, EU GMP, ICH, USP, EP, and other applicable regulatory standards.
  • Proven experience leading and supporting regulatory agency and client inspections.
  • Demonstrated ability to lead investigations (OOS/OOT/invalids, EM excursions), root cause analysis, and CAPA.
  • Strong written and verbal communication skills with the ability to present complex technical information clearly to internal stakeholders and clients.
  • Strong organizational and project management skills with the ability to manage multiple priorities in a fast-paced environment.
  • Proficient in Microsoft Office (Word, Excel, PowerPoint) with strong data interpretation, trending, and reporting capabilities.
  • Ability to work independently and collaboratively in a diverse, cross-functional environment.
  • Demonstrated client-focused mindset and experience supporting client programs.
  • Ability to handle confidential information and maintain data confidentiality and integrity.

 

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 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.