Associate Director of GMP Plasmids

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 for GMP Plasmids will be responsible for leading the clinical and commercial manufacturing of plasmid DNA (mRNA/gene therapy) and recombinant proteins. This role oversees the execution of validated upstream and downstream processes in a cGMP environment. Reporting to the Director of Manufacturing, the Associate Director will lead the internal GMP production team, manage management-level staff, ensure strict adherence to regulatory requirements, and drive tech transfer from R&D to Manufacturing.

Ensure all plasmid manufacturing activities are performed in strict accordance with cGMP, SOPs, and Batch Records.
Lead the transition of processes from R&D to a closed-system, commercial-compliant GMP environment.
Provide technical and operational oversight for in-house GMP facility selection, design, layout, and equipment qualification.
Lead FMEA and Root Cause Analysis (RCA) for manufacturing deviations and implement robust CAPAs.
Oversee Tracking and Trending of manufacturing yields, process parameters, and environmental monitoring data.
Review and approve technical reports, Master Batch Records (MBRs), and Standard Operating Procedures (SOPs).
Work with Project Management to develop GMP production timelines and ensure on-time delivery of clinical/commercial lots.
Manage the department budget, including COGs reduction initiatives and capital expenditure planning, under the guidance of the Director of Manufacturing.
Work closely with Quality Assurance and Quality Control to ensure product specifications and regulatory standards are met.
Exercise discretion, judgment, and personal responsibility in high-stakes manufacturing decisions.
Demonstrate a high level of integrity and maintain a positive, compliance-focused attitude.
Develop strategic planning and guidance for the GMP functional unit in alignment with the Director of Manufacturing and organizational goals.
Develop and define measurable objectives (KPIs) for staff to ensure high productivity and right-first-time manufacturing.
Cultivate a diverse and collaborative team environment with clear communication across shifts and departments.
Provide oversight on the development and enforcement of GMP procedures and controls within the plasmid unit.
Responsible for hiring, development, and professional mentoring of management and technical staff.
Ability to manage and influence people in direct and lateral support structures (e.g., MSAT, Engineering, Quality).
Interpret applicable regulations and guidance for application within the plasmid manufacturing unit.
Support the Director of Manufacturing in developing 3–5-year business plans for GMP plasmid capacity and revenue.
Maintain Revenue (P&L) responsibility for the GMP Plasmid business unit.
Support business development by participating in client audits and technical capabilities presentations.
Other duties as assigned.

What you bring to the team.

Must possess a relevant four-year degree OR relevant Master’s OR relevant PhD; a background in life sciences, biotechnology, or gene therapy industries preferred.
Broad knowledge of cGMP manufacturing with proven leadership skills in a regulated environment.
8 years of relevant cGMP experience, some specifically in Plasmids
Prior management experience is required; second-level manager capable of managing first-level managers and/or supervisors.
Excellent communication, organization, and project management skills with the ability to manage multiple GMP campaigns efficiently and adjust as priorities change.
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 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.

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