Interim Head of CMC

Outline:

Our client is seeking a highly experienced CMC expert. The interim needs to be capable of independently handling the full CMC development package including analytical method development and validation of the finished product, manufacturing of clinical trial material and IMPd/IND submission. Strong interpersonal skills, cross-functional outlook and understanding of the needs of internal and external stakeholders are essential.

Role Purpose:

To support early development pipeline products in relation to Chemistry Manufacturing and Controls (CMC) activities in a new spin-out company.

Requirements include:

• PhD in biological science, engineering or related area.
• At least 3 years of hands-on aseptic manufacturing development experience (specifically in ATMPs).
• Proven leadership, managerial experience. The ability to work under pressure and to aggressive timelines is also necessary.
• Strong background in process development.
• Current working knowledge of GMP requirements for ATMPs.
• Experience with manufacturing ATMPs for clinical trials.
• Good communication skills; able to interact with and influence individuals at CMO/CRO’s across a variety of functions (with and without a direct reporting
relationship).
• Ability to take a pragmatic approach to defining problems, resolving conflict, and developing practical solutions.
• Good understanding Quality Management Systems and proactive approach to resolving deviations and CAPAs.

Location: London

Duration and days per week: 3-6 months / Part time

Keywords: Head of CMC/CMC/ATMPs/Clinical Trials/GMP/Quality Management/CAPAs/PhD/Biological Science.