Intel Corporation is hiring a
Senior Director

Summary

The job is for a Senior Director of Manufacturing Science and Technology (MSAT) in an FDA-regulated environment with 10+ years of experience. The role involves leading internal teams and managing external partners, performing due diligence on potential partners, designing and managing validation studies, providing strategic oversight for manufacturing processes, and collaborating with cross-functional teams.

Requirements

• Minimum 10 years of experience in an FDA-regulated environment
• Minimum 7 years of experience in Manufacturing Science and Technology within the Pharmaceutical industry with an emphasis on monoclonal antibody manufacturing
• Demonstrated project management skills
• Demonstrated leadership and teamwork skills
• Excellent analytical and communication abilities
• Good understanding of process validation concepts and experience with technical transfer preferred
• Must have strong interpersonal skills, strong customer focus given the need to integrate activities with CMOs, cross-functional and collaborative partners
• Excellent presentation skills and the ability to concisely describe complicated issues to leadership team
• Must have hands on experience with drug manufacturing scale up, technical transfer, product process optimization and improvements
• Thorough understanding of commercialization process
• Direct experience with successful registrations and commercial launch of biotherapeutic moieties
• Knowledge of cGMP regulations, ICH guidelines, and world-wide health authority requirements
• Ability to lead in a dynamic group that takes a multi-disciplined team approach to executing and achieving departmental and corporate goals
• Hands-on, roll-up-your-sleeves approach with high sense of urgency and drive for results
• Demonstrated communication, problem-solving, leadership, and negotiation/decision-making skills
• Ability to think outside of the box and challenge the status quo
• Natural entrepreneurial spirit with unrelenting dedication to delivering results
• Desire to work in a fast-paced, innovative environment
• Natural collaborator who enjoys working on a cross-functional team

Responsibilities

• Lead investigation efforts on new and existing products
• Collaborate with CMC, Regulatory, Quality, Clinical Operations, and Supply Chain to develop and manage product lifecycle strategies
• Perform due diligence as needed on potential partners for fit and synergies within the current portfolio
• Design and manage validation studies, protocol development, data evaluation, preparation, and review and approval of study reports to support drug substance and product regulatory submissions
• Provide strategic oversight for drug substance and drug product manufacturing, device assembly, and supporting analytical/Quality Control laboratory operations
• Author and/or review protocols, development reports, batch records, standard operating procedures, and other technical reports to support regulatory filings
• Manage complex investigations where analysis of situations or data requires an in-depth evaluation of various factors
• Lead the development/optimization of scale-up/scale-down efforts to support on-going manufacturing
• Lead the development of in-process control strategies
• Work effectively in a cross-functional matrix environment, with both internal and external collaborators and proactively communicate with internal and external stakeholders
• Collaborate with internal resources, partners, consultants, and vendors for all technical operations related activities
• Supports quality and regulatory activities including site inspections, preparation of technical documents for BLA supplements, FDA observations, and all processing-related issues