Cell & Gene Therapy SME - US

ProPharma Group; Northern (KY); Hybrid; USD 120,000 - 180,000; Full time

Job summary

ProPharma Group is seeking an experienced CGT project manager to lead multi-disciplinary drug and device development programs. You will oversee planning, budgeting, and cross-functional coordination with clients and internal teams to ensure successful CGT project outcomes.

The role requires a strong background in CGT, GMP/ISO practices, and advanced proficiency with project management tools. Travel may be required depending on client location and project needs.

Qualifications

• Ten (10) years of multi-disciplinary CGT experience.
• Direct project management experience in CGT.
• Experience supporting sales activities of project services to clients.

Responsibilities

• Demonstrate subject matter expertise in CGT project execution across development, analytical method transfer, and facility qualification.
• Oversee planning, delivery, and budgeting for CGT projects spanning client teams and internal stakeholders.
• Drive risk management, meetings, and communications to ensure on-time, on-budget delivery.

Skills

CGT knowledge

PM leadership

Budget management

Communication

Cross-functional

MS Project

PowerPoint

Regulatory sciences

Education

BS/BA in Life Sciences

Tools

MS Project

Visio

SharePoint

Job description

For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.Essential Functions:* Demonstrate subject matter expertise in Cell and Gene Therapies (CGT) (e.g., product development, analytical methos development and transfer, facility startup and qualification, project management, process improvements, etc.) through the delivery of CGT projects.* Oversee or drive planning, delivery, communication, and operational / tactical aspects of the project(s).* Work independently with limited oversight from senior leadership.* Facilitate project team meetings, cross-functional communication and decision making, ensuring alignment with internal and external stakeholders.* Oversee and manage project financials.* Prepare project team budget including resources and costs, collaborating with Finance and other cross-functional departments.* Evaluate budget compliance and project billings on an ongoing basis.* Develop all project deliverables (e.g., project plan, charter, communication plans, presentations) and conduct reviews / approvals with client leadership.* Drive project communication (e.g., status reports, dashboards) to all impacted stakeholders.* Effectively conduct face-to-face and virtual ongoing meetings and workshops.* Own quality of work and most, if not all, deliverables under your responsibility.* Manage scope and monitor progress of project activities.* Proactively identify risks and issues in a timely manner, collaborate with colleagues and client lead(s) to resolve issues, and adjust project plans as needed.* Responsible for the schedule and quality of assigned projects, if applicable.* Support the project sales process with Business Development by developing content, reviewing content, and participating in sales meetings.* Support staffing client projects by identifying / recommending resources, conducting resume reviews, and interviewing resources, as requested.* Support the development of the Marketing and Sales plans and materials (e.g., thought capital, webinars) for CGT for the fiscal year.* Understand and track CGT-related industry trends; determine how to leverage for clients and turn into potential service offerings.* Participate in and present at industry associations and information exchanges related to development of related guidance and practice.* Ensure performance management processes (e.g., goal setting, performance evaluations) for personnel are completed in a timely manner.* Carry out supervisory responsibilities in accordance with the organization’s policies and applicable guidelines.* Participate in internal or client-required staff training.* Enforce Human Resources policies and procedures with the support of Human Resources staff.* Other duties as assigned.Necessary Skills and Abilities:* Demonstrated knowledge of the overall drug development process relevant to CGT operations.* Demonstrated knowledge of Good Manufacturing Practices and ISO relevant to CGT.* Advanced understanding and proficiency with utilizing PowerPoint, Word, Excel, Visio, Project, OneDrive, and SharePoint.* Good proficiency with project management practices, tools, and methodology.* Excellent analytical skills: (1) ability to access and resolve difficult business situations; (2) communicate complex issues in a simple manner.* Ability to organize and manage multiple projects.* Ability to make effective and persuasive presentations.* Excellent interpersonal skills, ability to develop important relationships with customers and key stakeholders, good conflict management skills.* Able to work effectively with local and virtual team members and other professionals.* Ability to earn and maintain a client’s confidence through appropriate planning, organizing, controlling, and directing of a project.* Proven track record of good decision making and exercising sound judgment.* Drive to Completion: Ability to think ahead, take initiative, maintain confidentiality, prepare action plans, meet deadlines and work in a team environment.* Results and high attention to detail.* Able to organize and perform own work tasks independently.* Excellent communication skills - excellent written and oral English skills is a must, any other language is a plus.* Willingness to travel.**Necessary Skills and Abilities:*** Demonstrated knowledge of the overall drug development process relevant to CGT operations.* Demonstrated knowledge of Good Manufacturing Practices and ISO relevant to CGT.* Advanced understanding and proficiency with utilizing PowerPoint, Word, Excel, Visio, Project, OneDrive, and SharePoint.* Good proficiency with project management practices, tools, and methodology.* Excellent analytical skills: (1) ability to access and resolve difficult business situations; (2) communicate complex issues in a simple manner.* Ability to organize and manage multiple projects.* Ability to make effective and persuasive presentations.* Excellent interpersonal skills, ability to develop important relationships with customers and key stakeholders, good conflict management skills.* Able to work effectively with local and virtual team members and other professionals.* Ability to earn and maintain a client’s confidence through appropriate planning, organizing, controlling, and directing of a project.* Proven track record of good decision making and exercising sound judgment.* Drive to Completion: Ability to think ahead, take initiative, maintain confidentiality, prepare action plans, meet deadlines and work in a team environment.* Results and high attention to detail.* Able to organize and perform own work tasks independently.* Excellent communication skills - excellent written and oral English skills is a must, any other language is a plus.* Willingness to travel.**Educational Requirements:*** B.S./B.A.in the Life Sciences; advanced degree in scientific discipline is desired.* Ten (10) years of relevant work experience may be substituted in lieu of education.**Experience Requirements:*** 10 or more years’ multi-disciplinary experience in the CGT pharmaceutical and biotech industries.* Minimum of 10 years’ direct project management in CGT.* Experience using Project Management software to manage complex project timelines and resources. (MS Project or other PM Enterprise software).* Experience in supporting sales activities of project services to clients.* Supervisory experience, including employee hiring and retention, oversight, performance review, employee development, and discipline.