Associate Director, Project Management - CMC/Gene Therapy (NJ, MA or Remote based) at PTC Therapeutics, Inc. in Pennington, New Jersey

Job Description:

Job Description Summary:

Job Description:

The Associate Director, Project Management – CMC/Gene Therapy leads and manages multiple Chemistry Manufacturing and Controls (CMC) projects. This includes, but may not be limited to, coordinating, supporting, and assisting in all aspects of cross-functional CMC projects and ensuring each project is defined and executed in a manner consistent with project management best practices and PTC’s project management governance. This role supports the Small Molecules Technical Operations function and collaborates closely with PTC’s Project Management Office (PMO).

The incumbent collaborates with internal personnel and externally with the Project Managers at PTC’s Contract Manufacturing Organizations (CMOs)/Contract Research Organization (CROs) to develop comprehensive project timelines. He/She implements the CMC strategy and actively monitors/reports on performance, highlighting assumptions and unknowns, to ensure full transparency to key internal/external stakeholders.

The Associate Director, Project Management – CMC/Gene Therapy supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate. 

Note: This position can be based in New Jersey, Massachusetts or be based remotely (US only)

Primary duties/responsibilities:

• Develops and manages integrated CMC timelines across programs within PTC’s Gene Therapy pipeline.

• Works closely with CMC Technical Operations to ensure all CMC team deliverables and activities are aligned across other functions. Facilitates communication to ensure clarity and transparency.

• Ensures that CMC timelines and dependencies align with the overall master project plan.

• Manages triple constraints (Cost, Schedule, Scope/Quality) across all CMC deliverables.

• Works closely, and communicates effectively with, cross-functional teams, leaders from PTC’s Gene Therapy functions and CMOs/CROs to ensure the team is set up to successfully deliver on all CMC project commitments.
  
  
  • Coordinates and leads project team teleconferences and meetings with key stakeholders.
  
  
  • Documents meeting minutes and manages action items.
  
  
  • Implements CMC project strategy.
  
  
  • Proactively defines potential risks and risk management strategies.
  
  
  • Identifies project objectives and scope.
  
  
  • Identifies measurable success criteria.
  
  
  • Builds a fully integrated schedule capturing all activities needed to deliver PTC Small Molecules business objectives.
  
  
  • Develops and implements stakeholder management and communication plans.
  
  
  
  

• Applies best practice project management techniques.

• Monitors and reports on the team’s progress against milestones and deliverables.


• Identifies and actively manages project issues to resolution.


• 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 across the company and with CMOs/CRO.

• Engages stakeholders with a solution-oriented focus and presents strategies and plans to senior management and governance forums.

• Fosters a culture of ownership and accountability including continuous evaluation, recognition, and process improvement.

• Performs other tasks and assignments as needed and specified by management.  

* Minimum level of education and years of relevant work experience.

• Bachelor’s degree in Science, Engineering or related discipline AND a minimum of 7 years of progressively responsible and related experience in a pharmaceutical, biotechnology, CMO, CRO or related environment at least 3 years of which will have been spent in a CMC Project Management role OR advanced degree in Science, Engineering or related discipline AND a minimum of 5 years of progressively responsible and related experience in a pharmaceutical, biotechnology, CMO, CRO or related environment at least 3 years of which will have been spent in a CMC Project Management role.

* Special knowledge or skills needed and/or licenses or certificates required.

• Demonstrated experience planning and leading large, complex, multi-year CMC projects.

• Demonstrated experience leading cross functional teams.

• Demonstrated ability to marshal the right resources to achieve project milestones and deliverables.

• Demonstrated ability to facilitate and manage project/team meetings.

• Demonstrated ability to embrace ambiguity and complexity.

• Demonstrated ability to translate complex concepts into actionable, measurable tasks.

• Demonstrated ability to create and foster effective relationships, motivate others, influence without authority, and collaborate internally and externally at all organizational levels.

• Skilled facilitator and negotiator with a keen eye for detail.

• Competent with MS Project Professional or other project management tools to manage project scheduling and tracking.

• Proficiency with Microsoft Office.

• Excellent verbal and written communication skills and strong presentation skills.

• High level of personal and professional integrity and trustworthiness with strong work ethic.

• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.

• 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. 

*Special knowledge or skills and/or licenses or certificates preferred.

• CMC project management background and understanding of clinical Gene Therapy drug development.

• Prior CMO project management experience.

• In-depth knowledge of cGMP requirements for pharmaceutical or biotechnology environment and understanding of biologics manufacturing and/or bioprocess/product/analytical development.

• Record of successful regulatory filings (INDs, BLAs, MAAs).

* Travel requirements

10-25%

EEO Statement:

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.

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