Small Molecule API Chemical Lead

TPM05679

Summary:
A pharmaceutical company in Barcelona is seeking a Small Molecule API Chemical Lead to support drug substance tech transfer and commercial manufacturing within its external manufacturing network. The successful candidate will provide process support to external partners for existing supply products, troubleshooting production issues, managing process changes, assessing technical risks, and driving process improvements. They will also oversee new product introductions and technical transfers, identifying risks in advance, providing on-site support during execution, and assisting with post-execution activities.

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.).
  •  Responsible 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.
  • Provide on-site coverage at external partner in support of commercial and / or tech transfer person in plant activities.
  • Translate understanding of GMP requirements and current regulations and develop standardized work to meet these requirements by partnering with operations, quality, and external partners.
  • Ensure that external partners are inspection ready for all routine inspections and / or inspections related to new product introductions or transfers, in concert with operations, quality, and regulatory.
  • Responsible for participation in creating, sharing, and adopting best practices and business process strategies.

Qualifications & Experience:

  • Bachelor’s degree in Chemistry, Chemical/Biochemical Engineering, Pharmaceutical Science or other related science or engineering field
  • A Minimum of 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 API chemical manufacturing in an API manufacturing facility.
  • Experience in Quality Risk Assessments, deviation management and change control.
  • Strong analytical problem-solving skills, root cause analysis, and risk assessment/mitigation.
  • Experience in Tech Transfers.
  • Proficient in both Spanish and English.
  • Travel will be a requirement of this position (Person in Plant support during Technical Transfers at External Partners)
  •  Project management experience preferred.
  •  Knowledge of worldwide regulatory requirements, experience supporting regulatory inspections preferred.
  •  Experience in ADC manufacturing preferred.

To apply for this job email your details to tim.mulhall@tandempm.ie.