As part of our continued growth, the newly created Associate Director, External Manufacturing - Gene Therapy is responsible for the oversight of manufacturing operations for pre-clinical, clinical and commercial stage gene therapy products at external Contract Manufacturing Organizations (CMOs). This includes the Chemistry Manufacturing and Controls (CMC) issues associated with these products. This position oversees late-stage development, post-approval CMC activities and clinical and commercial manufacturing of gene therapy products.
This position works cross-functionally with internal departments and external resources on process and analytical development, manufacturing and technology-related issues.

The Associate Director, External Manufacturing - Gene Therapy supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate. Primary duties/responsibilities:
Oversees the production of clinical and commercial gene therapy products at various CMOs that meet specifications and are compliant with cGMPs and external regulations.
Assists in guiding CMO’s daily operations for manufacturing and cleaning processes.
Partners with the CMOs to ensure manpower resources are adequate to complete operations.
In close collaboration with the CMOs, assists with investigations related to the manufacturing processes that may include one or more of the following: upstream, downstream and drug product (i.e. fill/finish). Works directly with CMOs to author deviations, non-conformances, and CAPAs as required. Partners with Quality function(s) to address these issues efficiently, effectively and compliantly.
Ensures documentation (batch records and SOPs) are accurate and updated as required.
Performs analyses and provides monthly manufacturing metrics as determined and required by management.
Leads technology transfer activities for new products and processes into the CMOs.
Provides manufacturing feedback on engineering related projects.
Actively identifies, recommends and implements opportunities for continuous 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 biochemistry, chemical engineering, bioengineering, or related technical field and a minimum of 7 years of progressively responsible experience in biopharmaceutical-based GMP manufacturing operations in a pharmaceutical, biotechnology, CMO or related environment OR equivalent experience and/or education.
* Special knowledge or skills needed and/or licenses or certificates required.

Demonstrated knowledge of all aspects of biologic drug manufacturing with applied experience in one of more of the following manufacturing processes: upstream, downstream, drug product (fill/finish)
Demonstrated experience in adherent or suspension cell culture, transfection, filtration, column chromatography, and/or aseptic fill/finish.
Demonstrated experience with scale-up and optimization of lab procedures up to commercial scale under GMP conditions.
Demonstrated knowledge of FDA regulations and expertise in GMP systems.
Demonstrated understanding of Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and Chemistry, Manufacturing and Controls (CMC) aspects of pharmaceutical products.
Demonstrated knowledge and application of Pharmaceutical Quality by Design (QbD) principles.
Experience overseeing/managing CMOs conducting clinical and commercial manufacturing.
Demonstrated ability to motivate and mentor peers and technical staff at CMOs by fostering a culture of continuous improvement and operational excellence.
Demonstrated leadership skills.
Project management skill set with experience in strategic/tactical planning, team building, and budgeting.
Ability to influence without direct authority.
Proficiency with Microsoft Office.
Excellent verbal and written communication and skills including demonstrated technical writing experience. Ability to communicate ideas and data both verbally and written in a persuasive and appropriate manner while using tact and diplomacy in interacting with people at all levels in organizations. 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/tasks.
*Special knowledge or skills and/or licenses or certificates preferred.

Small company and/or start-up experience.
Experience with virus or viral vector manufacturing and transfection a plus.
* Travel requirements 15-35%

Contact Information: Liz Colocho, email: This email address is being protected from spambots. You need JavaScript enabled to view it.

As a result of our continued expansion, this newly created role, 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 Gene Therapy 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.
Primary duties/responsibilities:
Develops and manages integrated CMC timelines across programs within PTC’s Gene Therapy (GT) 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 Gene Therapy 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%

Contact Information: Liz Colocho, email: This email address is being protected from spambots. You need JavaScript enabled to view it.