Associate Director Manufacturing - Oklahoma City, United States - Rbw Consulting
Description
We are seeking a highly motivated and experienced Associate Director, Manufacturing, to join an exciting Biotechnology company.You will play a critical role in ensuring successful client relationships, New Product Introduction (NPI / tech transfer) and GMP manufacturing of advanced therapies for multiple external partners according to their specifications.
In this CDMO environment, you will leverage your expertise in technology transfer, cost optimization, GMP compliance, regulatory audits, technical writing (Deviations, Change Control, CAPA etc), training, project management and client communications as a cross functional leader (or functional SME) for NPI.
As the company grows, there will be opportunity to mentor a direct functional team.Responsibilities
Technology Transfer Expertise:
o Lead the technology transfer process for client-derived advanced therapies, ensuring a smooth transition from development to cGMP manufacturing.
o Partner effectively with client teams and internal cross-functional departments (R&D, Quality, Process Engineering) to bridge the gap between development and manufacturing.
o Develop and maintain comprehensive technology transfer documentation to facilitate knowledge transfer and process understanding.o Strong stakeholder management to quickly gain alignment (internal/external) on complex topics.
Cost-Effectiveness and Client Focus:
o Champion continuous improvement initiatives within the assigned manufacturing projects, prioritizing cost-effectiveness while maintaining the highest quality standards.
o Collaborate with clients to identify opportunities for process optimization and cost reduction in their manufacturing processes.
o Ensure efficient resource allocation and utilization to meet project timelines and budgets.
GMP Compliance Leadership:
o Oversee the development, review, and implementation of cGMP documentation for client projects, including deviations, CAPAs, change controls, and Standard Operating Procedures (SOPs).
o Ensure all manufacturing activities comply with relevant cGMP regulations and client specifications and are embedded with error prevention mindset.
o Lead and mentor manufacturing personnel on cGMP principles and best practices.Project Management and Client Communication:
o Manage and lead assigned manufacturing projects for our clients, ensuring they are completed on time, within budget, and meet all quality and regulatory requirements.
o Effectively communicate project status and progress to clients and internal stakeholders.
Manufacturing Team Leadership:
o Provide leadership and guidance to the manufacturing team responsible for client projects, fostering a culture of quality, continuous improvement, and teamwork.
o Develop and coach team members to ensure they have the skills and knowledge to deliver exceptional service to clients.
o Identify and address performance issues within the manufacturing team.#J-18808-Ljbffr