
Website Asset Recruitment
Asset Recruitment
ref. 01257
Chemical Engineer – Technical Operations
Our client, a leading Pharmaceutical company based in Ireland, is seeking a highly motivated individual to fill an open position to support drug substance tech transfer and commercial manufacture within a External Manufacturing Network (Small Molecule API Chemical Technical Operations Unit) in Barcelona.
This is an opportunity to expand technical experience in API manufacturing, working with key strategic external partners. The 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.
Reporting to the Director, Chemical Technical Operations, External Manufacturing API Technology, you will be responsible for the management of the technical interface between our client and External Partners (EP), providing process support to External Partners for existing supply products to resolve production issues, evaluate and manage process change requests, manage process/technical risks, and provide guidance on process improvement and capacity optimization. You will also be responsible for providing 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.
Work location: Based in Spain (Barcelona).
Responsibilities
• Work with external partners to achieve business goals and to establish a common culture that benefits our company, external partners, and patients.
• Lead and act as the primary interface on technical issues between Chemical Technical Operations and external partner API manufacturers.
• Responsible for technical transfer activities, as applicable, through review of GMP documentation (eg: Master Batch Records, change control, protocols, reports, qualifications, etc.)
• Provide on-site coverage at external partner in support of commercial and / or tech transfer person in plant activities
• Accountable for technical activities for the commercial manufacturing process at the external partner, which includes authorship of change control, management of process improvement projects, statistical analysis of process performance, and investigation of atypical events.
• Develops solutions to complex technical issues that require a high degree of ingenuity, creativity and innovation. Requires understanding and application of principles, concepts, practices, and standards that govern the manufacturing of sterile products.
• Translate understanding of GMP requirements and current regulations and develop standardized work to meet requirements by partnering with operations, quality, and external partners
• Ensure that the external partners are inspection ready for all routine inspections and / or inspections related to NPI or transfers, in concert with operations, quality, and regulatory standards
Requirements
• Bachelor’s degree in Chemistry, Chemical/Biochemical Engineering, Pharmaceutical Science or other related science or engineering field
• Experience in API chemical manufacturing in an API manufacturing facility.
• 7 years+ post-bachelor’s degree experience in a GMP functional area or support of a GMP functional area, such as Operations or Technical Operations
• Experience in Tech Transfers
• Quality Risk Assessments, deviation management and change control experience.
• Strong analytical problem-solving skills, root cause analysis, and risk assessment/mitigation
• Accomplishment oriented (self-motivated and persistent), possess a “business owner” mentality, possess the ability to influence without authority, and demonstrate the ability to effectively operate in an ambiguous/changing environment.
• Proven collaboration and team building skills.
• Excellent command of English (both written and oral)
• Strong interpersonal and professional communication skills
• Working Across Boundaries – Must possess excellent interpersonal, communication, collaboration, negotiation skills to work outside boundaries as a norm.
• Travel will be a requirement of this position (Person in Plant support during Technical Transfers at External Partners)
Desirable
• Project management experience
• Knowledge of worldwide regulatory requirements, experience supporting regulatory inspections.
• Experience in ADC manufacturing.