[ref. g38309818] Lab Services Manager (2nd Shift Analytics) - Columbus

Overview of Andelyn Biosciences

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.

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.

The 2^nd Shift Analytics group works in collaboration with other groups within Laboratory Services to provide analysis and reporting of samples per client requirements

• Utilize management experience and expertise in lab operations to support in-process testing and characterization of intermediates as well as release and stability testing of gene therapy products.
• Work closely with other Laboratory Services groups to provide required analytical testing support.
• Hire, develop, and lead a team of scientists in the execution of analytical testing programs for gene therapy products.
• Support the characterization and testing of gene therapy drug products consistent with US FDA and EMA regulatory guidelines and expectations for gene therapy products in early and late stages of clinical development.
• Review and approve technical and scientific documents including study protocols and reports, qualification/validation documents, SOPs, and test methods.
• Collaborate effectively with research, CMC team, and clients to support IND enabling activities.
• Exercise discretion, judgment, and personal responsibility
• 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
• Demonstrate high level of integrity
• Maintain positive attitude
• Operate within the Quality Management System applicable to the manufacture of phase appropriate material in the CMF
• 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
• Anticipating problems and removing obstacles to enable staff to perform tasks as assigned.
• Work to specific measurable objectives requiring operational planning skill with little direct supervision
• Cultivate a diverse and collaborative team environment. Utilizes clear and concise communication to deliver high productivity and contribution to the success of department goals
• Developing and enforcing procedures and controls
• Drives development of procedures
• Has budgetary responsibility
• Moderate travel required
• Frequent involvement in audits
• Frequent involvement in customer relations
• Significant responsibility for inspection outcomes
• Responsible for hiring, development and related personnel processes
• Mentoring and professional development of staff
• Exercise crucial people skills
• Ability to manage and influence people in direct and lateral support structure
• Have significant latitude for making decisions for their operational or functional unit
• Drives timelines and development through broad influence
• Minimal interaction with legal services
• Other duties as assigned

• Must possess relevant four-year degree OR relevant Master’s OR relevant PhD preferred, background in the life sciences, biotechnology or gene therapy industries preferred.
• Seven years of experience required.
• Broad knowledge of the field with demonstrated leadership skills
• First-level manager. Manages activities of the team including supervisors and/or individual contributors
• Prior supervisory experience is required
• Excellent communication, organization, and project management skills with the ability to manage multiple projects efficiently and adjust as priorities change
• Must be proficient 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

• 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)

As an organization, we are committed to creating an environment where everyone ACCTS.