Job Description Summary:
The Associate Director, Manufacturing Science and Technology – Drug Product provides technical and operational support for manufacturing activities for commercial and late-stage clinical small molecule programs. Responsibilities include 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. The role also oversees early access and commercial label generation and release to ensure compliance with Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and International Conference on Harmonisation (ICH) guidelines.
The Associate Director acts as the primary manufacturing contact for drug product manufacturers, assisting in maintaining supplier relationships and production schedules.
This role collaborates cross-functionally with internal departments and external resources on Manufacturing Science and Technology-related issues and supports adherence to regulatory requirements and company Standard Operating Procedures (SOPs).
Job Description:
Responsibilities of the role include:
* Provide person-in-plant (PIP) technical support during drug product manufacturing, troubleshoot production issues, and travel to CMOs to monitor production.
* Coordinate manufacturing, packaging, and labeling activities, ensuring adherence to GMP, GCP, and ICH guidelines.
* Lead and execute drug product technology transfer, validation, and process improvement activities with manufacturing partners.
* Lead process validation lifecycle initiatives, including process performance qualification and continued process verification studies.
* Collaborate with internal and external manufacturing teams to troubleshoot or investigate manufacturing processes and author deviations, root cause analyses (RCA), non-conformances, and corrective and preventive actions (CAPAs).
* Monitor vendor activities, including reviewing vendor batch records, label copies, change orders, and invoices.
* Assist in the development and implementation of policies, procedures, and standards to ensure regulatory compliance.
* Coordinate authoring, reviewing, execution, and issuance of drug product process development, registration, and validation protocols and reports.
* Manage experiments and studies in support of root cause investigations and product/process impact assessments.
* Ensure documentation accuracy and updates for batch records and SOPs.
* Author and review relevant CMC sections for global regulatory submissions (IND/CTA, NDA).
* Monitor, analyze, trend, and report process performance and manufacturing data to identify continuous improvement and robustness initiatives.
* Provide manufacturing feedback on engineering-related projects.
* Identify, recommend, and implement opportunities for continuous improvement.
* Perform other tasks and assignments as specified by management.
Requirements for the role include:
* Education and Experience: Bachelor’s degree in a scientific or engineering discipline (chemical engineering preferred) with a minimum of 7 years of progressively responsible experience in small molecule drug product formulation and manufacturing, including at least 3 years performing person-in-plant, technology transfer, and process validation activities in a pharmaceutical, biotechnology, CMO, or related environment.
* Demonstrated knowledge/experience with development and manufacturing of oral solid dosage formulations.
* Excellent knowledge of GMP, GCP, and ICH guidelines related to clinical and commercial labeling and packaging operations.
* Experience with process validation and regulatory requirements.
* Experience with scale-up and optimization of lab procedures to commercial scale under GMP conditions.
* Knowledge and application of Pharmaceutical Quality by Design (QbD) principles.
* Experience overseeing/managing CDMOs conducting clinical and commercial manufacturing.
* Ability to motivate and mentor peers and technical staff at CDMOs.
* Leadership skills and expertise in project management for manufacturing transfers.
* Ability to influence without direct authority.
* Proficiency with Microsoft Office.
* Excellent verbal and written communication skills.
* Ability to work independently and collaboratively in a fast-paced, matrixed team environment.
* Analytical thinker with problem-solving skills and ability to adapt to changing priorities and deadlines.
* Excellent planning, organization, and time management skills.
Preferred Knowledge or Skills:
* People and project management experience.
* Experience working with both domestic and international CMOs.
Travel Requirements: 50-75%
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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