GMP Suspension Supervisor

Overview of Andelyn Biosciences

Our Values are founded in our origin story.

Evelyn received experimental gene therapy for spinal muscular atrophy in 2015. “Andelyn” combines their names, representing all the families who have courageously participated in the research that makes today’s gene therapies possible.

Andelyn Biosciences, a biopharmaceutical CDMO, has expanded to three buildings with more than 250,000 combined square feet of space. Located in the heart of Columbus, OH, 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.

It is 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 Supervisor is responsible for ensuring the GMP area delivers all products in a timely, compliant, and fiscally responsible fashion while ensuring all staff working in the manufacturing facility are appropriately trained and operate consistently following appropriate practices, batch records, and Standard Operating Procedures (SOPs) for manufacturing.

• Works in close collaboration with the Director of Manufacturing, Product Development Manager, Quality Control Manager, and Head of MS&T, to cultivate and enact strategic direction of the GMP area including determination of schedule and project timelines/capabilities
• Oversees all GMP resources and supply chain including vendors, inventory, production, and facilities, to meet production goals in alignment with the objectives of the Director of Manufacturing and the strategic plan and scientific objectives of Andelyn Corporate Center
• Oversees the proper operation, calibration, validation, cleaning, and maintenance of facility equipment and systems as specified in SOPs
• Directs and assists in daily operational activities related to the GMP Operations of biological products, including but not limited to the viral vector core, gene therapy vectors (e.g., Adeno-associated virus and Lentivirus), live viral vaccines, cell-based therapies (cultured and genetically modified hematopoietic stem cells for clinical and investigational use in Phase I and II human clinical trials), tissue engineering, recombinant proteins, and monoclonal antibodies
• Ensures that personnel training and adherence to appropriate and accurate documentation surrounding GMP activities supporting product quality is maintained
• Supports the Product Development Manager, the Quality Control Manager, the Quality Assurance group, and the MS&T group with deviation investigations, OOS results, process change controls, and required process SOP revision and remediation
• Responsible for overall GMP staff performance, including hiring, providing feedback, annual performance reviews, and termination if necessary
• Works in close collaboration with the Director of Manufacturing, the Product Development Manager, the Quality Control Manager and the Head of MS&T to ensure continuous improvement objectives are identified and met using metrics and other statistical means
• Respond to, and act 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
• 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 the broad influence
• Minimal interaction with legal services
• Other duties as assigned.

• Must possess a relevant four-year degree OR relevant Masters OR relevant Ph.D., background in the life sciences, biotechnology, or gene therapy industries preferred.
• 5 years of relevant work experience with Bachelor’s Degree, 2 with Master’s or PhD.
• Suspension experience required.
• 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

• The pride in contributing to the development and manufacturing of lifesaving 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)
• Valued as an employee.
• Opportunity for collaboration
• Full-time, Benefits-eligible.
• Health, Dental, and Vision insurance that starts on day one.
• Competitive Compensation Package
• Tuition Reimbursement and Repayment
• Life and AD&D insurance
• Supplemental insurance
• Paid parental leave.
• Wellness and Self-Care Programs
• 401(k) match
• EAP/work-life support system

Andelyn Biosciences is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, genetic information, disability, status as a protected veteran, or other characteristics protected by federal or state law.