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.
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 upstream manufacturing processes. 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 upstream manufacturing experience
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
*Physical requirements (only note if the job requires physical capacity beyond general office work)
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.