GEMMA Biotherapeutics Hiring for Chief Operating Officer at Philadelphia, PA Full Time

GEMMABio is a therapeutics company focused on speeding the research of and global access to life-changing advanced therapies for those living with rare diseases. The company will provide research and product development functions to bring gene therapy discoveries from the bench to the bedside faster and affordably.

GEMMABio is led by gene therapy industry pioneer Jim Wilson and his team of experts, who previously conducted their work in academia. Wilson is also the Chairperson of Franklin Biolabs, a Contract Research Organization. The collective goal of the two affiliated companies is to translate innovative scientific work into clinical trials, to then commercialize and distribute the new therapies around the world to patients who need them most.

The Chief Operating Officer (COO) will be a critical member of the executive team, responsible for overseeing and optimizing the company’s operational infrastructure. This includes leadership over Portfolio Management, Information Technology (IT), Facilities and Space Planning, Quality Assurance (QA), and CMC Process Sciences.

The ideal candidate is a seasoned biotech operations leader with a strong understanding of regulated environments and providing overall strategic and operational leadership. As a strategic partner to the CEO and leadership team, the COO will play a critical role in scaling operational infrastructure, ensuring compliance and efficiency, and supporting the successful execution of our R&D and clinical development goals. The position ensures that all program activities operate consistently within the mission, vision and values of the Company.

Essential Job Duties

Strategic and Operational Leadership

• Serve as a member of the Leadership Team, providing effective and inspiring leadership through active involvement in the management and oversight of department operations and staff.
• Lead the departments in addressing operational issues, implementing strategic priorities, problem solving, and orchestrating operational planning to ensure that all departments work efficiently and effectively.
• Lead, coach, develop, and retain a high-performance management team.
• Identify opportunities for the Company to leverage cross-program strengths to take advantage of new opportunities and/or to address organizational challenges.
• Prepare and submit an annual operating budget in collaboration with the CFO and CEO for review and approval, manage effectively within this budget, and report accurately on progress made and challenges encountered.
• Oversee and provide the leadership for the Company’s strategic planning process, and partner with the CEO in the development of the strategic direction of the Company through the governance of the Board of Directors. Provide programmatic leadership and input for strategic plan implementation processes. Provide leadership and coordination across the departments as they implement the strategic plan.
• Implement and lead a continuous quality improvement process throughout the program and service areas, focusing on process/systems improvement.
• Lead implementation of special projects and initiatives as required.

Portfolio Management

• Partner with PM Leadership to oversee the planning, budgeting, integration, tracking, and communications for cross-functional activities for GEMMABio’s product development programs, which range in scope from early discovery to Phase 1/2 clinical trials.
• Approves all project timelines and changes to the approved project plans.
• Drive effective, accurate, and timely communication across functional areas within R&D, work in close collaboration with functional area leadership across GEMMABio to anticipate, identify, and assess complex project issues that may pose a challenge to achieving strategic project/program goals.
• Key thought partner with CEO and the Leadership Team, identifying areas in need of enhanced operational efficiency to meet critical priorities.
• Maintain a working knowledge of the status of sponsor relationships and expectations.

Information Technology (IT)

• Oversee the IT function, ensuring secure, scalability, and compliant infrastructure.
• Develop IT policies and procedures that align with regulatory requirements and industry standards.
• Implement robust data backup and disaster recovery protocols to ensure business continuity.
• Drive digital transformation initiatives to regularly evaluate IT systems to ensure they meet the needs of the organization, including data integration, automation and enterprise software systems.
• Promote collaboration between IT and other departments to facilitate seamless technology adoption and integration.

Space Planning and Facilities

• Lead space planning strategy and manage lab/office expansions to meet the needs of a growing organization.
• Coordinate facilities operations to ensure safe, efficient, and compliant environments.

Quality Assurance (QA)

• Partner with QA leadership to maintain and evolve the company’s quality management systems (QMS) in line with regulatory requirements, including development of comprehensive SOPs and training programs to ensure the organization is knowledgeable about relevant GxP requirements.
• Support GxP readiness across teams and lead initiatives to ensure inspection preparedness.
• Ensure QA is leading collaborative Risk Management assessments across departments to develop risk registers associated with clinical trial or GMP manufacturing execution.
• Support initiatives aimed at continuously improving QA processes and systems and ensuring the overall QMS is aligned with organizational goals.

CMC Process Sciences

• Partner with Vector leadership to oversee process development and production operations including readiness for marketing authorizations.
• Ensure alignment of CMC strategies with program timelines and budgets.
• Develop Supply Chain Management to coordinate with suppliers and manage logistics to secure raw materials, reagents, and equipment necessary for production.
• Support collaborative risk management registers to identify and mitigate risks associated with manufacturing and control processes to ensure product safety and efficacy.

Qualifications And Requirements

• Advanced degree relevant in science, engineering, or business discipline (MBA, MS, or PhD preferred).
• 10+ years of progressive leadership in biotech/pharma, or life sciences.
• Proven experience managing cross-functional operations, including portfolio management, QA, IT, space/facilities, and manufacturing.
• Deep understanding of GxP regulations, biotech manufacturing, and regulatory frameworks.
• Demonstrated skills in leadership, communication, and cross-functional collaboration.
• Proven ability to operate effectively in a fast-paced, high-growth, and mission-driven environment.
• Advanced level of knowledge of the programs, operations, and financials of the Company.
• Ability to engage in and monitor decision-making process for complex organization-wide issues.