Head of CMC Strategy for Small Molecule Drugs

Allerton Bishop Search; England; Hybrid; GBP 150,000 - 210,000; Full time

Job summary

Allerton Bishop is partnering with an innovative specialty pharmaceutical company to appoint a Head of CMC based in England. The role provides strategic and technical leadership across late-stage small molecule programmes, shaping CMC strategy from concept to commercialisation.

You will lead cross-functional teams, oversee process development, analytical development, manufacturing, quality and regulatory affairs, and manage NDA submissions with the FDA.

Qualifications

• Significant experience in CMC leadership within pharma or biotech.
• Strong knowledge of small molecule product development and lifecycle.
• Experience leading programmes from PhIII to regulatory approval.
• Proven ability to manage external CDMOs and partnerships.
• Solid GMP, ICH guidelines and regulatory understanding.

Responsibilities

• Define and lead the global CMC strategy across a portfolio of small molecule products.
• Provide strategic oversight from early development through commercial manufacture.
• Lead cross-functional CMC teams spanning PD, Analytical Development, Process Development, Manufacturing, Quality and Regulatory.
• Drive technical development activities, ensuring milestones are met.
• Oversee NDA submissions with the FDA.
• Provide scientific leadership in technology transfer, validation, scale-up and manufacturing.
• Collaborate with external CDMOs and manufacturing partners to ensure successful product development.
• Identify regulatory risks and implement robust mitigation strategies.
• Support due diligence, portfolio expansion and business development from a CMC perspective.
• Represent CMC in senior governance meetings and advise executive leadership.

Skills

CMC leadership

Small molecule development

Programme leadership

Cross-functional teamwork

Regulatory knowledge

Education

Bachelor's degree in Pharmacy, Chemistry, or related

Job description

Allerton Bishop is partnering with an innovative specialty pharmaceutical company to appoint a Head of CMC based in England. The role provides strategic and technical leadership across late-stage small molecule programmes, shaping CMC strategy from concept to commercialisation.

You will lead cross-functional teams, oversee process development, analytical development, manufacturing, quality and regulatory affairs, and manage NDA submissions with the FDA.