Company: Confidential
Job Title: Dir., Clinical Trial Manufacturing
Job Number: 91581
Location: Boston, US
Job Description
The Director of Clinical Trial Manufacturing will oversee the operations of the internal radiopharmaceutical manufacturing facility to support investigational products. This role involves managing production planning, scheduling, and resource allocation to ensure alignment with the company’s portfolio needs and clinical demands.
Responsibilities
* BS in Chemistry, Engineering, or related field preferred. * 10+ years of experience in clinical development and manufacturing within the biotechnology or pharmaceutical industry, specializing in Radiopharmaceutical cGMP operations, aseptic processes, and equipment/qualification. * Knowledge of nuclear safety regulations and guidelines. * Proven expertise in technology transfer and process validation management. * Experience with antibodies, imaging, and radiometal therapeutics. * Skilled in organizational development, personnel management, and resource allocation. * Familiar with the drug approval process and experienced in supporting FDA approval for branded and generic products. * Strong communication skills.
Required Skills
* Hire and manage manufacturing personnel. * Ensure product quality, production standards, and compliance with regulations. * Maintain a safe working environment in collaboration with safety staff. * Keep records in line with state and federal regulations. * Lead and optimize team performance. * Oversee equipment purchases, maintenance, and layout. * Drive productivity while meeting quality and regulatory goals. * Lead process qualification, validation, and IND submissions. * Contribute to CMC sections and regulatory reports. * Conduct clinical readiness activities. * Maintain KPIs and internal reports. * Author manufacturing documentation with internal teams. * Analyze manufacturing data with Quality to identify improvements. * Assess and mitigate risks in cGMP processes. * Support regulatory processes including batch release and change control. * Foster data-driven decision-making and scientific rigor. * Demonstrate persistence for organizational success. * Promote transparent communication and a positive, respectful culture.
Application Deadline: 2025-02-17
To apply for this job please visit jobrxiv.org.