GMP Operations Senior Scientist (Cell Culture)

Overview of Andelyn Biosciences

Andelyn Biosciences is a biopharmaceutical Contract Development and Manufacturing Organization (CDMO) focused on advancing novel gene therapies from concept to commercialization. Located in the heart of Columbus, OH, the company has expanded to three buildings with more than 250,000 combined square feet of space. 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.

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.

What you will do.

The GMP Operations Senior Scientist (Cell Culture) is responsible leading production activities within a cGMP clean room environment. This role will closely collaborate with Operational Leadership on daily priorities and provide hands-on leadership for production activities, production, and project timelines, as well as staffing requirements. Senior Scientists are looked to be the subject matter experts and will ensure training, documentation, and regulatory and fiscal compliance.

Expect excellence from the production team. Lead from a position of influence, coaching, and collaboration alongside 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 all needs and provide potential resolutions to maintain successful production activities
Work with the supply chain to requisition and dispose of materials. Ensure material timelines are met to achieve production goals.
Create, lead, and manage change requests (CR) and corrective and preventive actions (CAPA) needed to ensure production changes and improvements are implemented in a timely manner.
Lead all aspects of the production documentation/client batch record requirements, adhering to GDP standards set forth by the company.
Regularly engage with QA staff and management to investigate deviations in manufacturing processes.
Actively engage with project teams to bring new projects and processes to GMP production in a timely manner.
Respond to equipment alarms for relevant areas, escalating issues as required to ensure product quality and safety.
Operate with high regard to all policies and procedures to ensure adherence to regulatory and quality standards.
Exercise great attention to detail, integrity, discretion, leadership, and personal responsibility.
Utilize clear and concise communication to deliver high productivity and contribute to the success of the team and its goals.
Moderate involvement in audits, inspection outcomes, and client communications.
Mentor and develop other Operations staff.
All other duties assigned.

What you bring to the team.

Must possess a 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.
Prior supervisory experience is preferred.
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.
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.

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 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.

Apply for this job

First name

Last name

Email address

Location

Phone number

Resume

Attach resume

Attach another file

Attach file

Skills Self-Assessment

Please share your experience with each of these skills

What is your experience level with a Sartorious Single Use Bioreactor?

What are your salary requirements?

Are you willing to relocate?

Are you authorized to work in the United States?

Will you now or in the future require sponsorship for employment visa status (e.g. H-1B status)?

What is your earliest start date?

Are you 18 years of age or older?

Are you willing to work evenings?

Are you willing to work weekends?

What is the highest level of education you’ve obtained?

How did you hear about Andelyn Biosciences?

Please provide the name of the Career Fair/Conference.

Please provide the name of the Employee.

If not listed above, please provide the name of the Job Board.

We invite you to complete the optional self-identification questions below used for compliance with government regulations and record-keeping guidelines. Any self-identification information provided will not be considered in the selection process.

GENDER

VETERAN STATUS Learn more about veteran statuses

If you believe you belong to any of the categories of protected veterans listed below, please indicate by selecting the appropriate category(ies). The hiring employer is subject to the Vietnam Era Veterans' Readjustment Assistance Act of 1974, as amended by the Jobs for Veterans Act of 2002, 38 U.S.C. 4212 (VEVRAA) and requests this information in order to measure the effectiveness of the outreach and positive recruitment efforts it undertakes pursuant to VEVRAA.

DISABILITY STATUS Learn more about disability statuses

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.