PMO & Operational Excellence Manager

2 weeks ago

Columbus, Ohio, United States Andelyn Biosciences Full time

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 RealityTM 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 PMO (Project Management Office) Manager is responsible for defining, establishing, maintaining, and ensuring project management standards across the organization. This individual will be responsible for the identification, evaluation, and management of site-wide projects and continuous improvement initiatives. The PMO manager will effectively lead a team of project managers and operational excellence specialists. Project Management and Lean Six Sigma certification/experience are required (PMP/Six Sigma black belt certification preferred), as well as regulatory knowledge and adherence.

Establish and maintain the PMO through the standardization of tools, methodology, systems, and communication of managed projects.
Develop standards templates and processes for project management and continuous improvement initiatives.
Evaluate proposed projects to ensure deliverables meet the established requirements and are aligned with business objectives.
Define requirements to evaluate proposed projects to determine feasibility, capacity requirements, and benefits/return for the organization.
Approve project charters based on the business need/justification, project scope, team members, deliverables, and timeline.
Establish a system/process to evaluate and categorize projects to ensure the team's experience and capacity are appropriately allocated.
Evaluate cost to determine budgetary impact and ensure required funding is appropriated.
Define and maintain KPIs and site metrics to monitor performance.
Develop dashboards to effectively display and communicate site performance and the status of projects.
Celebrate wins and learn from challenges.
Schedule and facilitate stakeholder meetings to communicate project status, discuss escalated issues, and ensure the project is meeting customer requirements.
Effectively communicate identified issues (and remediation plans) that may impact the successful implementation of project deliverables.
Establish operational excellence training to educate employees and promote a culture of continuous improvement.
Mentor, develop, and collaboratively work with the team to promote and fully leverage the team's experience and potential.
Perform in accordance with established policies, procedures, and techniques and utilize training, common experience, or working knowledge related to the tasks performed.
Maintain compliance with applicable regulatory requirements for cellular and gene therapy products.
Utilizes clear and concise communication to ensure the team is fully integrated across the organization.
Utilizes business acumen and considers business impacts in planning and problem-solving.
Demonstrate a high level of integrity through exercising discretion, judgment, and personal responsibility while maintaining a positive attitude.
Exercise discretion, judgment, and personal responsibility.
Demonstrate a high level of integrity.
Maintain a positive attitude.
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.
Give strategic guidance to the units under control.
Work on specific measurable objectives requiring operational planning skills with little direct supervision and involved in the development of those objectives.
Cultivate a diverse and collaborative team environment. Utilizes clear and concise communication to ensure high productivity and contribution to the success of department goals.
Developing and enforcing procedures and controls
Translate strategy into workable procedures and work instructions.
High levels of budgetary control over the functions under their control
Frequent travel required.
Ultimate responsibility in audits
Ultimate responsibility in customer relations
Ultimate responsibility for inspection outcomes
Responsible for hiring, development, and related personnel processes.
Mentoring and professional development of staff
Make use of essential people skills, including the ability to develop subordinates.
Ability to manage and influence people in the direct and lateral support structure.
Exercise broad decision-making latitude within their functional units.
Drives timelines and development through the broad influence
Significant interaction with legal services
Develop and direct short and near-term goals.
Interprets Regulations for application within their functional unit.
Has business acumen and considers business impacts in planning and problem-solving.
Other duties as assigned.

What you bring to the team.
Must possess relevant four-year degree OR relevant master's degree, background in Project Management and Operational Excellence (certification preferred)
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 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 in contributing to the development and manufacturing of lifesaving therapies.

The invaluable experience of being a part of building the foundation of a new organization.
The opportunity to collaborate with 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.

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