GMP Senior Scientist

Andelyn Biosciences, Inc•Columbus, OH

1d•Onsite

About The Position

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 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.

Requirements

Relevant four-year degree OR relevant Masters OR relevant PhD, background in the life sciences, biotechnology or gene therapy industries preferred.
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.
Excellent detailed knowledge of cGMP, GLP, and FDA guidelines.
Excellent communication, organization, and project management skills with the ability to manage multiple projects 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.
Client-focused mindset in daily tasks.
Prior experience handling confidential information and the ability to maintain confidentiality.

Nice To Haves

Prior supervisory experience is preferred.

Responsibilities

Lead production activities within a cGMP clean room environment.
Collaborate with Operational Leadership on daily priorities and provide hands-on leadership for production activities, production, and project timelines, as well as staffing requirements.
Ensure training, documentation, and regulatory and fiscal compliance.
Coach and collaborate with production staff.
Assign tasks to production staff to ensure schedules and metrics are met for client and company deliverables.
Conduct adherent and suspension cell line scale-up to support ongoing large-scale manufacturing.
Troubleshoot production issues, escalate needs, and provide potential resolutions.
Work with the supply chain to requisition and dispose of materials, ensuring material timelines are met.
Create, lead, and manage change requests (CR) and corrective and preventive actions (CAPA).
Lead all aspects of production documentation/client batch record requirements, adhering to GDP standards.
Engage with QA staff and management to investigate deviations in manufacturing processes.
Engage with project teams to bring new projects and processes to GMP production.
Respond to equipment alarms and escalate issues as required.
Operate with high regard to all policies and procedures to ensure adherence to regulatory and quality standards.
Exercise attention to detail, integrity, discretion, leadership, and personal responsibility.
Utilize clear and concise communication.
Participate in audits, inspection outcomes, and client communications.
Mentor and develop other Operations staff.

Benefits

Competitive compensation
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)