Manager, Manufacturing Science & Technology (Drug Product) - Gene Therapy 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) (Drug Product) - Gene Therapy is responsible for leading Chemistry, Manufacturing, and Controls (CMC) lifecycle management projects at internal and external manufacturing facilities for pre-clinical, clinical, and commercial stage gene therapy products.  The scope of this position includes functioning as a drug product manufacturing and device Subject Matter Expert (SME) providing technical support for process development and scale up, technology transfer, process validation, technical support during clinical and commercial manufacturing, and general oversight and support to the CMC development lifecycle. 

This position works cross-functionally with internal departments and external organizations on process development, manufacturing, and regulatory submissions.

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

Primary duties/responsibilities:

• Leads drug product manufacturing development, scale up, technology transfer and production of clinical and commercial gene therapy products at Contract Manufacturing Organizations (CMOs) and internal manufacturing facilities.

• Provides person-in-plant (PIP) technical support during manufacturing, providing real time process troubleshooting as the manufacturing process subject matter expert for drug product (fill/finish).

• Leads the evaluation of drug product to device compatibility.

• Collaborates with Process Development in establishing risk assessments and process control strategies. Establishes process validation master plans, protocols, and reports for gene therapy programs.

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

• Leads manufacturing studies including authorship of protocols and reports, engagement with internal/external manufacturing partners, coordination for execution of studies, and analysis of data.

• In collaboration with CMOs and internal manufacturing, assists with root cause analysis (RCAs) for investigations related to the manufacturing process. Works directly with CMOs to author and review deviations, non-conformances, and CAPAs as required. Partners with Quality function(s) to address these issues efficiently, effectively, and compliantly.

• Supports the CMC team in developing scope and timelines for drug product development and manufacturing initiatives.

• Works closely, and communicates effectively with, cross-functional team members, 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.

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

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

• Master’s degree in biochemistry, chemical engineering, bioengineering, or related technical field AND a minimum of 6 years of progressively responsible experience in biologics process development or manufacturing technical support roles OR a Bachelor’s degree in biochemistry, chemical engineering, bioengineering, or related technical field AND a minimum of 8 years of progressively responsible experience in biologics process development or manufacturing technical support roles.

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

• Demonstrated subject matter expertise in drug product manufacturing with applied experience in sterile filtration, aseptic processing and qualification of aseptic processes (media fill), vial fill, labeling and inspection for biologics or gene therapy (preferred) products.

• Demonstrated experience in optimization and troubleshooting of manufacturing processes.

• Demonstrated experience with process scale-up of biologics programs to clinical or commercial manufacturing scales under GMP conditions.

• Demonstrated understanding of Good Manufacturing Practice (GMP), GMP systems, and FDA regulations.

• Demonstrated knowledge and application of biologics process validation lifecycle practices and Pharmaceutical Quality by Design (QbD) principles.

• Experience supporting outsourced process development and manufacture of clinical and commercial supplies.

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

• Demonstrated project leadership skills.  Ability to influence without direct authority.

• 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.

• Prior experience developing and / or evaluating compatibility of drug delivery devices.

• Prior experience working within a small company and/or start-up environment.

• Prior experience supporting or developing gene therapy viral vector manufacturing processes.

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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