Associate Director, Manufacturing Sciences and Technology/Drug Product - Gene Therapy (Hybrid role - Hopewell NJ/WFH) - Military Veterans

at PTC Therapeutics

Pennington, New Jersey

Job Description Summary:

Job Description:

As part of our continued growth, the newly created Associate Director, Manufacturing Sciences & Technology (MS&T) - Gene Therapy, Drug Product is responsible for drug product laboratory management, fill/finish technology transfer, process validation, drug device, and manufacturing process technical support for both internally and externally produced pre-clinical, clinical, and commercial stage gene therapy products. This position works cross-functionally within a chemistry, manufacturing, and controls (CMC) team as the drug product lead to enable the successful production of gene therapy drug products and to support regulatory interactions/submissions.

She/He may manage direct reports.

The incumbent will work cross-functionally with internal departments and external resources on manufacturing sciences and technology-related issues.

The Associate Director, MS&T - Gene Therapy, Drug Product supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Primary duties/responsibilities:

  • Designs fill/finish processes (including media fill validation, visual inspection, filling/stoppering/capping, etc) and leads fill/finish technology transfers from manufacturing sites and oversees the scale up and production of clinical and commercial gene therapy products at contract development and manufacturing organizations (CDMOs) and internal manufacturing sites as appropriate.

  • Oversees the design and execution of in-house drug product-related experiments including primary/secondary packaging selection and optimization, filtration selection/validation, container closure studies, shipping simulation, device compatibility, and other drug product studies.

  • Oversees experimental activities at CDMOs including leachable/extractable studies, container closure studies, filtration development/validation, and other drug-product related studies/testing.

  • Acts as person-in-plant (PIP) technical support staff during drug product fills and provides real-time process troubleshooting as a manufacturing process subject matter expert for fill/finish processes.

  • Leads process validation lifecycle initiatives, including process performance qualification and continued process verification studies. Collaborates with Process Development in establishing risk assessments, process design/characterization, and process control strategies.

  • In close collaboration with the internal manufacturing and external CDMO teams, assists with troubleshooting or investigations related to the manufacturing processes. Works directly with manufacturing and quality teams to author deviations, non-conformances, and CAPAs as required. Partners with Quality function(s) to address these issues efficiently, effectively and in a compliant manner.

  • Authors, reviews and approves manufacturing documentation (batch records, SOPs, protocols) as required.

  • Ensures documentation (batch records and SOPs) are accurate and updated as required.

  • Authors and reviews relevant drug product CMC sections for global regulatory submissions -Investigational New Drug (IND), Investigational Medicinal Product Dossier(IMPD), Biological License Application (BLA), Marketing Authorization Application (MAA), etc.

  • Actively identifies, recommends, and implements opportunities for continuous improvement.

  • May manage, coach and mentor direct reports.

  • 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 biology, biochemistry, chemistry, chemical engineering, bioengineering, or related technical field and a minimum of 10 years of progressively responsible relevant experience in biologics/ gene therapy drug product process development, technology transfer, and/or Good Manufacturing Practice (GMP) manufacturing operations in a pharmaceutical, biotechnology, CDMO or related environment OR equivalent experience and/or education (MS + minimum 8 years; PhD+ minimum 6 years.)

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

  • Demonstrated knowledge of all aspects of biologic drug product manufacturing with applied experience in formulation/filtration development, primary/secondary packaging design/validation, and fill/finish operations.

  • Demonstrated experience in primary packaging qualification/validation, filtration development/validation, and fill/capping operations.

  • Demonstrated experience with drug product manufacturing/validation.

  • 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 CDMOs conducting experimentation or clinical/commercial manufacturing.

  • Demonstrated ability to motivate and mentor peers and technical staff at CDMOs by fostering a culture of continuous improvement and operational excellence.

  • Demonstrated leadership ability and experience managing, coaching and mentoring direct reports.

  • 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 drug product manufacturing a plus.

Note: This is a hybrid role, with time spent working at our Hopewell NJ facility and remotely/WFH.

**At PTC Therapeutics we are seeking candidates in the United States who are fully vaccinated against COVID-19 or who will be fully vaccinated by the time they begin the position.

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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Pennington, New Jersey

PTC is a science-driven, patient-centered biopharmaceutical company focused on discovering, developing & commercializing medicine for patients with rare disease.