GMP Scientist I

Andelyn-Biosciences; Columbus (OH); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

Paid Time Off

401(k) Match

Life Insurance

Tuition Reimbursement

Employee Assistance Programs

Flexible work options

LinkedIn Learning access

Job summary

Andelyn Biosciences in Columbus, Ohio is seeking a GMP Operations Scientist I to support all aspects of GMP production in the Clinical Manufacturing Facility. You will work with GMP management and staff to execute production processes, maintain documentation, and support facility and equipment maintenance with a focus on timely, compliant, and fiscally responsible manufacturing of biological products.

You will contribute to continuous improvement, ensure ALCOA documentation, and collaborate

Qualifications

• Must possess a relevant four-year degree and background in the life sciences, biotechnology, or gene therapy industries preferred.
• No minimum experience required but suspension experience is preferred.
• 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

Responsibilities

• Supports GMP operations to execute production processes, documentation, and facility/equipment maintenance.
• Collaborate with GMP Management and staff to implement strategic direction and timelines.
• Maintain materials inventory control to meet production goals.
• Respond to alarm notifications from monitoring systems for storage units during the assigned period.
• Ensure proper documentation and adherence to SOPs for manufacturing biological products.
• Assist in process documentation reviews, revisions, remediation, and change controls.
• Adhere to ALCOA documentation principles in all production activities.
• Support deviation investigations, OOS results, and process troubleshooting.
• Work with GMP Management to identify and meet continuous improvement objectives using metrics.

Skills

Communication

Project management

Organization

Education

Four-year degree

Tools

PowerPoint

Excel

Word

Job description

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 therapypatientswho 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 acceleratethedevelopment and manufacturing of innovative therapies to bring more treatments to more patients. We are Turning Hope Into Reality™ through our ACCTSions.

ACCOUNTABLEin our actions.

COMPASSIONATEin our thinking.

TRUSTWORTHYin our communications.

SUPPORTIVEof one another.

Employees are expected to perform the following essential functions under the framework of ourACCTSions.

What you will do.

The GMP Operations Scientist I is responsible for supporting all aspects of Good Manufacturing Practices (GMP) production in the Clinical Manufacturing Facility (CMF). Working in collaboration with the manager of GMP operations and staff, the scientist, I will provide hands‑on assistance for all day‑to‑day GMP production operations, including the execution of production processes, documentation, and facility and equipment maintenance. The Scientist I will support production efforts to deliver all products in a timely, compliant, and fiscally responsible fashion by following appropriate practices, production documentation, and Standard Operating Procedures (SOPs) for manufacturing biological products.

• Works in collaboration with GMP Management and Staff to cultivate and enact the strategic direction of the GMP area, including the determination of schedule and project timelines/capabilities
• Supports GMP resources and supply chain, including maintaining materials inventory control to meet production goals
• 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.
• Performs daily operational activities related to the GMP manufacturing of biological products by executing production processes, including assuring the availability of materials and the proper documentation surrounding GMP activities and product quality
• Assists in process documentation review, revision, remediation, and process change controls
• Learn the skills necessary for performing critical operations in the GMP manufacturing facility.
• Develop the ability to lead auxiliary operations • Assists in process documentation review, revision, and remediation.
• Adhere to good documentation principles and ALCOA in support of all production activities.
• Assists the GMP Management and staff with deviation investigations, OOS results, and process troubleshooting
• Works in close collaboration with GMP Management to ensure continuous improvement objectives are identified and met using metrics and other statistical means
• Exercise discretion, judgment, and personal responsibility
• Demonstrate a high level of integrity
• Operate within the Quality Management System applicable to the manufacture of appropriate material in the manufacturing facility.
• Maintain compliance with applicable regulatory requirements for cellular and gene therapy products
• 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
• 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 the team and goals
• Documentation of all activities performed according to SOPs
• Make decisions based on established procedures
• Nominal fiscal responsibility
• Other duties as assigned

What you bring to the team.

• Must possess a relevant four‑year degree and, background in the life sciences, biotechnology, or gene therapy industries preferred
• No minimum experience required but suspension experience is preferred.
• 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

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 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 Biosciencesembraces diversity and is an equal opportunity employerand 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 everyoneACCTS.

We are required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years.

Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self‑identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

Yes, I Have A Disability, Or Have A History/Record Of Having A Disability No, I Don’t Have A Disability, Or A History/Record Of Having A Disability I Don’t Wish To Answer