Associate Director - DS API External Chemical Technical Operations - Remote Eligible

Technical Lead

Our Small Molecule API Chemical Technical Operations Unit is seeking a highly motivated individual to fill an open Technical Lead position to support drug substance tech transfer and commercial manufacture within our External Manufacturing Network. This is an exciting opportunity to work with key strategic external partners, grow technical experience in API manufacturing, and work on high visibility network initiatives. Our team strives to provide technical excellence in our work and be strong partners, collaborators, and leaders within the small molecule line of business at our company.

This position reports to the Director, Chemical Technical Operations, Small Molecule API External Manufacturing. The Technical Lead will be responsible for the management of the technical interface between our company and External Partners (EP). The technical lead will provide process support to External Partners for existing supply products to resolve production issues, evaluate and manage process change requests, proactively assess, and manage process/technical risks, and provide guidance on process improvement and capacity optimization. The technical lead will also provide oversight of External Partners during New Product Introductions and Technical Transfers, proactively identifying process/technical risks as part of pre-execution activities, providing on-site support during execution, and supporting post-execution activities.

Key Responsibilities:

• Operate independently on priorities established with assigned External Partners.
• Foster proactive partnerships with External Partners to meet business goals, identify and mitigate risks, and continuously enhance performance.
• Maintain a strong focus on compliance and Environmental Health and Safety (EHS) to drive supply excellence.
• Serve as the primary technical contact for assigned External Partners while coordinating with impacted company sites and External Partners.
• Collaborate with internal teams to ensure seamless product supply with an end-to-end mindset.
• Initiate and drive change controls to completion.
• Provide rapid support to External Partners to resolve manufacturing challenges and minimize supply disruptions.
• Collaborate with Research Laboratories groups during New Product Introductions/Technical Transfers and new technology development.
• Offer on-site support at External Partners as required, proactively identifying risks and supporting all phases of execution.
• Conduct technical due diligence assessments and provide expert consultation on chemical manufacturing matters.
• Review process change requests and deviation reports while ensuring regulatory compliance.

Education and Minimum Requirements:

• Bachelor's degree in engineering, chemistry sciences or related discipline with a minimum of 7 years of relevant work experience in manufacturing or development, in the areas of process start up, technology introduction, manufacturing and/or technical transfer.
• A minimum of 7 years of experience in manufacturing, specifically in Small Molecule API process production, development, optimization, and technical transfer.
• GMP experience in pharmaceutical manufacturing, ensuring compliance with quality and regulatory standards.

What You Bring:

• Exceptional organizational skills and the ability to work independently.
• Proven leadership attributes including a global mindset, an end-to-end supply chain perspective, and strong collaborative abilities across functions and geographies.
• Demonstrated capacity to solve complex technical challenges, lead project teams, and influence stakeholders effectively.
• A solid understanding of small molecule pharmaceutical manufacturing processes.
• Fluency in Italian & English is essential
• Ability to travel up to ~50%

Required Skills:

Adaptability, Automation Systems, Capital Project Management, Change Management, Clinical Manufacturing, Data Analysis, Decision Making, Drug Product Manufacturing, Interpersonal Relationships, Lean Manufacturing, Manufacturing Scale-Up, Regulatory Compliance, Root Cause Analysis (RCA), Strategic Thinking, Technical Transfer

Requisition ID: R392751