Director of Small Molecules CMC

Director of Small Molecules (CMC)
 

Greater London

Competitive Salary

RBW Consulting are delighted to be partnered with a UK-based international biopharmaceutical company focused on the development and commercialization of innovative therapeutics that aim to improve outcomes for people in both oncology and rare diseases. Our client has already delivered 5 successful phase 2 studies and their pipeline consists of 6 clinical stage product candidates making it an exciting time for the company.

An opportunity has arised to join the CMC team as a Director of Small Molecules (CMC) on a permanent basis. Reporting into the SVP CMC, you will focus on development and delivery of CMC small molecule development and manufacturing, while managing multiple global CMOs and providing programme leadership.

Responsibilities:

• Accountable individual for the phase appropriate development and delivery of CMC small molecule development and manufacturing including the delivery of clinical supplies
• Manage multiple global Contract Manufacturing Organisation(s) (CMOs) for process optimization, cGMP manufacture and supply of Drug Substance (API) intermediates and Drug Product in support of ongoing clinical programs. This may require travel as needed to CMO sites to ensure implementation and compliance
• Work with CMOs and development partner(s) to set and agree the technical and manufacturing strategy for the project in partnership with the Clinical Development Team, Quality, Regulatory, Finance, Commercial and Business Development functions
• Technical review, approval and sign-off on CMO documents (including but not limited to technical specifications, batch records, development and validation plans, shelf-life extension(s), reports, project risk assessments)
• Escalate high impact technical, quality, timeline, regulatory and partner relationship issues that will significantly impact the outcome of the clinical development project to the Clinical Development Project team and as appropriate to senior management level
• Anticipate future manufacturing, development CMC program requirements, prepare budget forecasts and review and manage budget as program evolves
• Prepare, update and quality review CMC components (Module 2, 3) of regulatory dossiers to ‘submission ready’ level
• Author internal technical and manufacturing reports, review and feedback on CMC reports prepared by other SME’s
• Oversee vendor selection, tech-transfer, scale-up, ongoing manufacturing at CMOs and in partnership with Legal function ensure required agreements are in place in a timely manner
• Work collaboratively with other functions to prepare, review CMC information for partnering activities and new asset due diligence
• Work with Quality to continuously improve CMC functional policies and procedures

Requirements:

• Bachelor’s degree or higher within a relevant subject such as chemistry, medicinal chemistry, pharmacy, or a related scientific discipline
• Extensive experience in CMC - pharmaceutical development of small molecule (NCE) products across clinical development through to commercialization
• Ability to function as hands-on CMC Program Lead and key point of contact to CMOs to manage process/analytical development, validation, specifications, manufacturing, testing and release of API and drug product including oversight of agreed budget
• Extensive pharmaceutical industry experience (biotech industry experience a bonus)
• Detailed knowledge of global CMC regulatory requirements (minimum US FDA, EMA and MHRA) and successful track record of delivering high quality CMC components of dossiers that comply with these
• Experience in the outsourcing development, manufacturing, and international vendor selection/oversight
• Experience with technology transfers, scale-up and on-going manufacture at CMOs
• Experience in managing and directing multiple projects
• Effective project management skills - ability to develop high level work plans with tasks, timeframes, milestones resources and dependencies and to integrate into project plans provided by CMOs