Manager, Manufacturing Sciences & Technology - Gene Therapy (Upstream/Cell Culture) - NJ or Northeast US/Mid Atlantic US Remote based at PTC Therapeutics, Inc. in Pennington, New Jersey

Job Description:

Job Description Summary:

Job Description:

In this newly created role, the Manager, Manufacturing Sciences & Technology (MS&T) - Gene Therapy (Upstream/Cell Culture) is responsible for technology transfer, process monitoring, process validation, 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 technology transfer lead to enable the successful production of gene therapies and to support regulatory interactions/submissions.

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

The Manager, MS&T - Gene Therapy (Upstream/Cell Culture) supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Primary duties/responsibilities:

• Leads technology transfers from manufacturing sites and process development 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.

• Acts as person-in-plant (PIP) technical support staff during manufacturing and provides real time process troubleshooting as a manufacturing process subject matter expert for upstream processing.

• 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 and external manufacturing 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.

• Designs and executes experiments and studies in support of root cause investigations, product/process impact assessments, process improvements, and process validation using appropriate scale-down models.

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

• Leads the monitoring of process performance through application of statistical process control methodologies. Analyzes process development and manufacturing data to identify continuous improvement and robustness initiatives.

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

• Authors and reviews relevant drug substance and drug product CMC sections for global regulatory submissions (IND/IMPD, BLA/MAA, etc).

• 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.

This position can be based out of our Hopewell, NJ facility or be based remotely (home based) within the Northeast US or Mid Atlantic US regions with ability to travel as noted/required.

* 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 5 years of progressively responsible experience in biopharmaceutical-based process development, technology transfer, and/or GMP manufacturing operations in a pharmaceutical, biotechnology, CDMO 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 upstream and cell culture

• Demonstrated experience in adherent and/or suspension cell culture, transfection, and filtration.

• Demonstrated experience with scale-up and optimization of lab procedures 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 CDMOs conducting clinical and 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 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.

* Travel requirements

15-35%

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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