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Job Description Summary:

The Director, Manufacturing Science and Technology - Drug Product, provides technical and operational support for manufacturing activities for commercial and late-stage clinical small molecule programs for the drug product including, but not limited to, formulation compounding, primary/secondary packaging, technology transfer, and process validation at contract manufacturing organizations (CMOs). This position supports process development, regulatory interactions/submissions, and clinical and commercial manufacturing. He/she also oversees early access and commercial label generation and release to ensure Good Manufacturing Practice (GMP), Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines.The Director, Manufacturing Science and Technology-Drug Product also acts as primary manufacturing contact for the drug product manufacturers and assists in maintaining excellent supplier relationships and timely production schedules.The incumbent works cross-functionally with internal departments and external resources on Manufacturing Science and Technology related issues. The Director, Manufacturing Science and Technology- Drug Product ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.Job Description:

ESSENTIAL FUNCTIONS

Primary duties/responsibilities:

• Evaluates external vendors/resources necessary to ensure the successful execution of drug product supply plans, creates Requests for Proposals (RFPs), participates in contract negotiations and facilitates the execution of legal documents required to engage the vendor's services.
• Coordinates activities related to manufacturing, packaging, and labeling, ensuring adherence to GMP, GCP and ICH guidelines.
• Accountable for person-in-plant (PIP) technical support staff during manufacturing. Provides production process troubleshooting including travel to CMOs to monitor production of drug product; interfaces with CMOs and internal departments to facilitate the manufacture and release of drug product.
• Manages and executes activities related to drug product technology transfer, validation and process improvements to manufacturing partners.
• 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 compliantly.
• Monitors existing vendors' activities. This includes, but is not limited to, reviewing vendor batch records, randomization files, label copies, variable text documentation, change orders, distribution procedures and invoices.
• Assists in the identification, development and implementation of policies, procedures and standards which impact the department, while working to ensure compliance with applicable regulatory requirements.
• Coordinates the authoring, reviewing, execution and issuance of drug product process development, registration and validation protocols and reports; supports the authoring and review of the manufacturing-related sections of regulatory submissions (domestic and international).
• Manages the execution of experiments and studies in support of root cause investigations and product/process impact assessments.
• Ensures documentation (batch records and SOPs) is accurate and updated as required.
• Authors and reviews relevant drug substance and drug product CMC sections for global regulatory submissions (IND/CTA, NDA, etc).
• Monitors, analyzes, trends, and reports process performance and manufacturing data to identify continuous improvement and robustness initiatives.
• 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.

KNOWLEDGE/SKILLS/ABILITIES REQUIRED

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

• Bachelor's degree in a scientific or engineering discipline (chemical engineering preferred) and a minimum 10 years of progressively responsible experience in small molecule drug product formulation and manufacturing (mainly oral solid dosage forms), with a minimum of 3-5 years in technology transfer, and process validation related activities, in a pharmaceutical, biotechnology, CMO or related environment.

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

• Demonstrated knowledge/experience with development and manufacturing of oral solid dosage formulations of small molecule modality
• Excellent knowledge of GMP, GCP, and ICH guidelines related to clinical and commercial labeling, and packaging operations and the overall drug development process.
• Demonstrated experience with process validation and regulatory requirements.
• Demonstrated experience with scale-up and optimization of lab procedures up to commercial scale under GMP conditions.
• 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.
• Demonstrated expertise in the development of project plans for manufacturing transfers, including the ability to manage multiple projects.
• Ability to influence without direct authority.
• Proficiency with Microsoft Office.
• Excellent verbal and written communication skills.
• 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.

Special knowledge or skills and/or licenses or certificates preferred.

• People and project management experience.
• Experience working with both domestic and international CMOs.

Travel requirements

• 25-50%

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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, p regnancy, 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.