The Project Coordinator, CMC/Gene Therapy is a part of the Technical Operations organization and more specifically to the Manufacturing Science and Technology (MS&T) department. This function supports CMC cross-functional teams to ensure projects meet objectives and are delivered on-time.
Under the general supervision of a Manager or Associate Director, the Project Coordinator, CMC/Gene Therapy is primarily responsible for the following:
Coordinating, supporting, and assisting in all tactical and logistical aspects of cross-functional CMC projects in close collaboration with CDMOs, CROS, Analytical Development and other CMC functions.
Working in partnership with the internal CMC Project Manager and other external CMC project managers to develop and maintain the timelines required to support the projects.
Tracking progress towards milestones and communicating potential risks and conflicts.
Proactively identifying potential deviations via routine communications and timeline reports.
The Project Coordinator, CMC/Gene Therapy supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
Creates detailed work breakdown structures for project and sub-team deliverables that identify and sequence activities to be completed.
Develops and manages integrated CMC timelines.
Monitors the progress of the project, makes any necessary adjustments and reviews the quality of the completed work on a regular basis.
Adjusts project timeline(s) in response to progress, unanticipated delay(s) and changing business environment.
Identifies project risks and develops/implements appropriate mitigation strategies.
Facilitates communication with CDMOs/CRO.
Fosters a culture of ownership and accountability including continuous evaluation, recognition, and process improvement.
Documents meeting minutes, action items, and key decisions to maintain program documentation and ensure aligned communication within the program team.
Coordinates internal and external meetings required to support achievement of the program objectives.
Helps to develop presentations for management updates and reporting on team’s progress and recommendations for program strategy.
Organizes gene therapy drug substance and drug product sample logistics between internal PTC and external CDMO or CRO partners.
* Minimum level of education and years of relevant work experience.
Bachelor’s degree in Science, Engineering or related discipline AND a minimum of 3 years of progressively responsible and related experience in a CMC Project Management role in a pharmaceutical, biotechnology, CMO, CRO or related environment OR an Associate’s degree in a relevant discipline and a minimum of 5 years of related professional experience in these same environments OR equivalent experience and/or education.
* Special knowledge or skills needed and/or licenses or certificates required.
Proficiency with Microsoft Office including in-depth experience/proficiency with Microsoft Project.
Familiarity with SharePoint including the ability to maintain a project team site, create new folders, upload and share documents.
The ability to collaborate with members of the cross-functional program team to understand deliverables, activities and decisions required to advance the project.
Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
Excellent verbal and written communication and skills.
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects including high level of attention to detail.
Strong team player with good interpersonal skills and communication skills.
Ability to multi-task and perform under demanding and aggressive timelines while remaining focused on the program goals.
Proven ability to interact with different functional groups.
*Special knowledge or skills and/or licenses or certificates preferred.
Knowledge of enterprise project management systems for portfolio and resource management.
Project Management Professional (PMP) Certification
PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.