Sr. Specialist - QC Oversight - Andelyn Biosciences, Inc

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 for 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 thedevelopment 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 Senior Specialist, QA (QC Oversight) will play a key role in supporting the QC sub-function to ensure the highest standards of professional excellence and quality assurance in the business, with responsibility for supporting the Quality Management System(QMS), in place, adhering to all regulatory, cGMP and company requirements and ensuring all necessary plans and standards are achieved by consistently maintaining a high level of Quality. This position will report to the QA Supervisor and will work closely with the QC team and will support internal Quality Assurance functions focused on GMP operations and associated quality systems.

• Monitor industry practices and relevant regulatory and pharmacopoeia guidance for gene therapy product testing to ensure compliance.
• Lead gap assessments and mitigation plans as needed
• Review and approve test methods and method validation/transfer reports
• Review and approve lab investigations associated with release testing and method validation/transfer at the site or contract testing laboratories
• Support product sample management (e.g., reserve, reference standards) and cell bank management
• Interface and communicate with the Client, Analytical Development teams, and the Quality Control departments in meeting project timelines, providing deliverables and resolving issues.
• Lead the QA review of analytical data, including data audit trails
• Manage and train others on activities related to QA support of analytical activities
• Review and approve analytical instrument qualification protocols and reports as needed
• Manage cross-functional teams, including organizing and prioritizing daily tasks
• Participate in authoring, review, and approval of new or revised standard operating procedures, specifications, forms, test methods and other controlled documents to ensure high quality documents and compliance with current Good Manufacturing Practices (GMPs)
• Support internal and external audits, site inspection readiness activities, and continuous improvement initiatives
• Participate in review and approval of Deviations, CAPAs, and Change Management records as required
• Participate in the QA oversight of stability program and lifecycle management of test method initiatives
• Communicate with cross-site teams to align practices and drive continuous improvement
• Demonstrate a high level of integrity
• Maintain a positive attitude
• Maintain compliance with applicable regulatory requirements for cellular and gene therapy products
• Attention to detail in all job functions
• Operates in alignment with established policies, procedures, and techniques, requiring relevant training, practical experience, or a working knowledge of the tasks involved.
• Solving, correcting, preventing problems, and performs tasks as assigned by leadership, as well as assigning tasks to junior staff
• Work to specific measurable objectives requiring operational planning skills with little direct supervision
• Leads and supports a diverse and collaborative team environment. Utilizes clear and concise communication to deliver high productivity and contribution to the success of team and goals
• Documentation of all activities performed according to SOPs
• Make decisions based on established procedures
• Has fiscal responsibility
• Infrequent travel required
• Moderate involvement in audits
• Moderate involvement in customer relations
• Moderate responsibility for inspection outcomes
• Influences hiring, development, and related personnel processes
• Mentoring and professional development of staff
• Other duties as assigned

What you bring to the team.

• Must possess relevant four-year degree OR relevant master’s OR relevant Ph.D., background in the life sciences, biotechnology, or gene therapy industries preferred
• Five years relevant (w/4 YR deg) OR three years (w/Masters)
• Experience in biologics or gene therapy required
• Experience Quality Assurance/Quality Control function reviewing Analytical testing for analytical assays such as ELISA, DDPCR, HPLC, SDS-PAGE, Western blot OR as an Analytical Chemist with some documentation review.
• Familiarity with biological assay and method development (i.e. ELISA, HPLC, ddPCR, Western Blot, qPCR, etc) a plus.
• Experience in highly regulated field preferred
• Proficient knowledge of cGMP regulations and guidelines including but not limited to U.S. Code of Federal Regulations 21 CFR Part 11 and Part 210 & 211, European Directives, ICH guidelines, and cGMP regulations
• Experience in commercial and clinical GMP production and ability to provide QA support for both
• Experience with aseptic manufacturing operations required.
• 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 that have over 10 years in the gene therapy field.
• Competitive compensation
• Eligible 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.