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Proclinical is seeking an MSAT Associate Director to oversee the successful transfer and optimization of pharmaceutical manufacturing processes. In this role, you will leverage your scientific expertise to ensure compliance with GxP regulations, manage technical transfers between sites, and drive continuous improvement initiatives. You will work closely with internal teams and external partners to maintain product quality, resolve manufacturing challenges, and support portfolio growth. This position involves global collaboration and occasional travel to manufacturing sites.
Job Responsibility:
Ensure adherence to GxP regulations and standard operating procedures
Lead technical transfers of manufacturing processes, providing critical expertise and direction
Establish and track KPIs, budgets, and timelines for process transfers and improvements
Represent technical expertise in cross-functional projects, including supply chain, regulatory, and commercial activities
Provide scientific advice to procurement and regulatory teams, addressing batch failures, recalls, and variations
Conduct technical reviews and due diligence for potential acquisitions and divestments
Collaborate with manufacturing sites to optimize processes and resolve compliance or quality issues
Review and approve technical documentation, including certificates of analysis, stability data, and risk assessments
Manage quality records such as change control requests and deviations
Propose and implement technical and business improvements to enhance practices and systems
Requirements:
Degree in Life Sciences, Pharmacy, Pharmaceutical Sciences, or Chemistry
Proven experience in site-to-site technical transfers and pharmaceutical manufacturing processes
Familiarity with small molecule formats, including sterile products, capsules, creams, gels, ointments, and solid dose
Knowledge of Quality Management Systems, including change control and deviation management
Experience in operational budget management and strategic alignment
Proficiency in project management tools, templates, and methodologies
Strong problem-solving skills and ability to adapt to high-speed changes
Excellent organizational, communication, and time management skills
Demonstrated leadership and collaboration abilities across global teams
Commitment to continuous improvement and ethical standards