What are the responsibilities and job description for the Senior GMP Technician position at Andelyn Biosciences, Inc?
Overview of Andelyn Biosciences
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.
What you will do.
The GMP Operations Support Sr. Technician is responsible for supporting all aspects of the GMP Manufacturing Operation and production in the Commercial Manufacturing Facility (CMF). Working in collaboration with operations leadership, the Sr. Technician will provide coordination and hands on assistance to the overall production operation.
They will assist other technicians as well as scientists to ensure work is done accurately, completely and timely as to not delay production activities while adhering to all SOPs, WINs and other instructions for manufacturing Andelyn’s products.
- Coordination and scheduling of all GMP technician activities.
- Engages with leadership priorities to ensure the facility is prepared for upcoming activities to minimize delays.
- Takes initiative/ownership of production and business-related tasks including but not limited to: inventory activities, production material/supply scheduling, staging materials/supplies/equipment, locating equipment, moving fixtures in, out, and around the facility, set up/cleaning of rooms for production, and environmental monitoring.
- Coordinates equipment movement, location/tracking, and performs designated maintenance activities as directed by leadership in conjunction with Engineering and Maintenance.
- Engage with other functional groups in the organization to ensure production needs are communicated and followed up on, as appropriate.
- Demonstrates expert knowledge of pertinent SOPs. Maintains requests, and reviews appropriate documentation (i.e. forms, logbooks) as required by GMP regulatory standards.
- Meets or exceeds regulatory standards of quality as evidenced by quality assurance inspections and ensuring an “audit ready every day” mindset, line of sight, and compliance for manufacturing and related areas.
- Gives training and acts as a subject matter expert for job related activities.
- Exercise discretion, judgment, and personal responsibility.
- Demonstrate high level of integrity.
- Maintain positive attitude.
- Attention to detail in all job functions.
- Performs in accordance with established policies, procedures, and techniques and requires training common experience or working knowledge related to the tasks performed.
- Works under supervision of leadership and senior staff.
- Documentation of all activities performed according to SOPs.
- Other duties as assigned.
What you bring to the team.
- Must possess High School Diploma/Equivalent, background in a highly regulated industry preferred.
- Three years relevant work experience.
- Excellent communication, organization, and project management skills with the ability to manage multiple projects efficiently and adjust as priorities change.
- Ability to perform work with little to no assistance.
- Ability to lead through influence.
- Must be computer 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 and quality 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.
- 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)
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.