GMP Senior Scientist

Valid8 Financial, Inc.; Columbus (OH); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

401(k) Match

Medical Insurance

Dental Insurance

Vision Insurance

Paid Time Off

Holidays

Life Insurance

Disability Insurance

Parental Leave

Tuition Reimbursement

LinkedIn Learning access

Employee Assistance Programs

Flexible work options

Job summary

Andelyn Biosciences in Columbus, OH, seeks an Operations leader to supervise production teams within a cGMP environment. The role focuses on coaching staff, maintaining schedules, and ensuring quality in viral vector and plasmid manufacturing.

You will drive CAPA, change control, and GMP document control while collaborating with QA and project teams to scale new processes for clinical and commercial production.

Qualifications

• Bachelor's degree or higher in life sciences (biotech preferred).
• First-level leadership; coordinates daily team activities.
• Prior supervisory experience preferred.

Responsibilities

• Lead production team and coach staff to meet schedules and metrics.
• Assign tasks to ensure client and company deliverables are met.
• Scale-up cell lines for large-scale manufacturing; troubleshoot issues.
• Manage CAPA and change requests for process improvements.
• Oversee GMP documentation and batch records; maintain quality.
• Engage with QA and project teams to bring new projects to GMP production.
• Respond to equipment alarms; escalate to ensure product quality and safety.
• Mentor and develop other operations staff.

Skills

Leadership

cGMP knowledge

FDA guidelines

Project management

MS Office

Education

Bachelor's degree or higher in life sciences

Tools

Microsoft Office

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 inColumbus, 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 thedevelopmentand manufacturing of innovative therapies to bring more treatments to more patients. We are Pioneering Solutions that Turn Hope into Reality™ through our ACCTSions.

A CCOUNTABLE in our actions.

C OMPASSIONATE in our thinking.

T RUSTWORTHY in our communications.

S UPPORTIVE of one another.

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

What you will do.

• 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, elevate 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.

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.