GMP Quality Control Scientist I (2nd Shift)

Overview of Andelyn Biosciences

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.

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 Scientist I will aid QC Management in ensuring that their assigned tasks are performed by following appropriate regulatory practices, analytical methods, and Standard Operating Procedures (SOPs) for GMP.

• Operate within the Quality Management System applicable to the manufacture of phase-appropriate material in the CMF
• Maintain compliance with applicable regulatory requirements for cellular and gene therapy products
• Works in close collaboration with the QC Management and senior QC staff to cultivate and enact strategic direction of the GMP area including determination of schedule and project timelines/capabilities.
• Provides QC Management with all laboratory data generated from QC laboratory tasks, including in-process, release, and stability testing. Manages and reviews the compilation of all data and ensures its correctness
• Assists in shipment and communications with all external QC laboratory activities in coordination with QC Supervisor
• Assists QC Management with the management of laboratory investigations, the QC portion of deviation investigations, OOS results, process change controls, and required process SOP revision and remediation
• Works in close collaboration with the QC Management and senior QC staff to ensure continuous improvement objectives are identified and met using metrics and other statistical means
• Works in close collaboration with the QC Management and senior QC staff to ensure new projects and technologies are sought for incorporation into the GMP area
• 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.
• Exercise discretion, judgment, and personal responsibility
• 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 CMF
• Maintain compliance with applicable regulatory requirements for cellular and gene therapy products
• Attention to detail in all job functions
• Performs by established policies, procedures, and techniques and requires training common experience or working knowledge related to the tasks performed
• Identifies problems and performs tasks as assigned
• Work under the general supervision of senior staff and leadership
• Works in a diverse and collaborative team environment utilizing clear communication to deliver high productivity and contributes to the success of team and goals
• Documentation of all activities performed according to SOPs
• Make decisions based on established procedures
• Nominal fiscal responsibility
• Other duties as assigned

• Must possess a relevant four-year degree, a background in the life sciences, biotechnology, or gene therapy industries preferred
• No minimum experience
• Experience in highly regulated fields preferred
• Excellent communication, organization, and project management skills with the ability to manage multiple projects efficiently and adjust as priorities change.
• Must be literate in Microsoft Office (PowerPoint, Excel, Word)
• 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 collaborate with 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)

As an organization, we are committed to creating an environment where everyone ACCTS.