Manager, Manufacturing Science & Technology (Lab CMC) - 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) (Lab CMC)- Gene Therapy is responsible for leading laboratory based 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 technical leadership 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 resources on process and analytical development, manufacturing, and regulatory submissions.

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

Primary duties/responsibilities:

• Contributes to the designs and actively executes studies supporting upstream and/or downstream manufacturing development including creation of scale down models for deviation investigation and process improvement(s), to enable production of clinical and commercial gene therapy products.

• Oversees the 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 upstream and/or downstream activities

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

• 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.

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

• 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.

• This role may manage director reports (full time employees or contractors) as deemed necessary by management and business needs.

• 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 of all aspects of biologic drug manufacturing with applied experience in upstream and/or downstream manufacturing processes.

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

• Demonstrated mastery of Good Manufacturing Practice (GMP), expertise in GMP systems, and working knowledge of FDA regulations.

• Demonstrated subject matter expertise in biologics process validation lifecycle practices and Pharmaceutical Quality by Design (QbD) principles.

• Experience overseeing/managing CMOs conducting 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 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.

• Small company and/or start-up experience.

• Experience with virus or viral vector manufacturing and transfection a plus.

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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