Head of Chemistry, Manufacturing and Controls (CMC)

This is a fully remote position, open to applicants in California, +1 more state.

📋 Description

• Define and spearhead phase-appropriate global CMC strategies across various modalities for a wide array of international clients.

• Provide thought leadership to enhance the VCLS profile, which includes delivering presentations at conferences, hosting webinars, and engaging with VCLS clients.

• Facilitate our clients’ development of biologics, oligonucleotides, combination products, and cell & gene therapies.

• Guide the development of scalable manufacturing and analytical strategies.

• Draft and review technical documentation, and offer input and support to CMC team members.

• Supervise IND, CTA, BLA, NDA, MAA, and IMPD CMC documentation.

• Act as the CMC representative in interactions with health authorities.

• Manage relationships with external partners, including auditing and consulting firms.

• Drive performance improvements and resolve issues effectively.

• Lead and nurture a team of 5–10 staff members.

• Foster a high-performing and collaborative work culture.

• Collaborate with Regulatory, non-clinical, clinical, and business development teams to provide phase-appropriate solutions for VCLS clients and contribute to the growth of the VCLS business.

⛳️ Requirements

• A degree in a relevant scientific field.

• Extensive industry experience in CMC and drug development.

• Proficiency in biologics, oligonucleotides, combination products, and cell & gene therapies.

• Experience in managing mid to large-sized teams.

• Strong background in regulatory submissions (US and/or UK/EU).

• Familiarity with GMP and international regulatory standards.

• Experience working with CDMOs.

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Opportunities for professional development and continued education.

• Comprehensive health and wellness benefits.

• Flexible working arrangements.

• A collaborative and inclusive workplace culture.