Director, Clinical Trial Manufacturing

Job Description: Director of Clinical Trial Manufacturing

About Our Client
Our client is a trailblazing biotechnology company transforming cancer treatment with a novel class of targeted radiopharmaceuticals aimed at addressing a broad spectrum of solid tumor cancers. Incubated by MPM Capital and supported by a team of experienced entrepreneurs and drug developers, our client utilizes proprietary platforms to create tumor-targeting agents with optimal properties for radiotherapy.

Their innovative molecules are designed to achieve deep tumor penetration and extended residence times, enabling rapid clearance from non-target tissues. This approach not only maximizes tumor destruction while minimizing side effects but also allows clinicians to visualize and verify target engagement prior to administering therapeutic radioisotopes.

Position Summary

The Director of Clinical Trial Manufacturing will oversee the activities related to the internal radiopharmaceutical manufacturing facility, supporting the development and clinical supply of our client's investigational theragnostic products. The ideal candidate will lead the establishment and maintenance of manufacturing operations, aligning with the company's portfolio needs and clinical demands. This role includes managing daily manufacturing operations, production planning, scheduling, and resource allocation.

Key Responsibilities

• Team Leadership: Hire, develop, and manage a skilled manufacturing operations team to ensure production meets performance, quality, and compliance standards.
• Production Oversight: Supervise the manufacture of radiopharmaceutical products, maintaining compliance with cGMP, safety regulations, and quality standards.
• Regulatory Compliance: Ensure compliance with federal and state regulations governing radiopharmaceutical manufacturing, collaborating with environmental, health, and safety staff. Maintain detailed records in accordance with regulatory requirements.
• Facility and Equipment Management: Oversee equipment procurement, maintenance, and facility layout to optimize production processes.
• Process Qualification and Validation: Lead process qualification and validation campaigns, contributing to CMC sections and relevant regulatory submissions (e.g., IND filings).
• Clinical Readiness: Execute clinical readiness activities such as compatibility studies, transportation studies, and aseptic process qualifications.
• Documentation: Partner with internal CMC teams to author and review manufacturing documentation, including specifications, analytical methods, batch records, protocols, and reports.
• Quality Assurance: Collaborate with Quality teams to review manufacturing data, analyze trends, and implement risk-reduction and continuous improvement initiatives. Provide technical assessments for batch release, change controls, deviations, OOS results, and CAPAs.
• Metrics and Reporting: Maintain key performance indicators (KPIs) and internal reports to track manufacturing performance and improvements.
• Cross-Functional Collaboration: Work closely with Quality, Supply Chain, and external manufacturing teams to align on goals and deliverables.
• Culture of Excellence: Foster a culture of rigor, innovation, and data-driven decision-making. Emphasize scientific excellence and collaboration to advance novel therapies for patients.

Qualifications

• Education: Bachelor's degree (minimum) in Chemistry, Engineering, or related field. Advanced degrees preferred.
• Experience: At least 10 years of experience in radiopharmaceutical cGMP operations, including aseptic processes, equipment qualification, and process validation.
• Regulatory Knowledge: In-depth understanding of nuclear safety regulations, cGMP guidelines, and the drug approval process. Experience in FDA approvals for branded and generic products is highly desirable.
• Technical Expertise: Familiarity with antibodies, imaging, and therapeutic radiometals. Proven experience in technology transfer and operational management.
• Leadership Skills: Demonstrated ability to lead teams, optimize performance, and drive organizational goals. Skilled in resource and budget management.
• Communication: Strong written and verbal communication skills, with the ability to engage effectively across cross-functional teams and external stakeholders.
• Desirable Certifications: Relevant certifications in quality assurance, regulatory affairs, or radiopharmaceutical production.

Core Competencies

• Transparent and effective communication skills, fostering open dialogue and diverse perspectives.
• Adaptability to manage ambiguity and solve complex challenges.
• Positive energy and respect for team dynamics.
• Strong drive to contribute to a mission-driven organization advancing transformative therapies for patients.

Equal Opportunity Employer
Our client is an equal opportunity employer and does not discriminate based on age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any other classification protected by law.