Head of Chemistry, Manufacturing and Controls (CMC)

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🏄 California, Massachusetts – Remote

🏄 California – Remote 🍂 Massachusetts – Remote

⏰ Full Time

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Voisin Consulting Life Sciences (VCLS)

WebsiteLinkedInAll Job Openings

201 - 500 employees

💼 Consulting

📦 Logistics

🧬 Biotechnology

Consulting • Logistics • Biotechnology

Voisin Consulting Life Sciences (VCLS) is a global reference partner that expedites access to HealthTech products in regulated markets. With a focus on regulatory science, VCLS supports Biotechnology, Pharmaceutical, and Medtech manufacturers throughout the product development lifecycle, from discovery to commercialization. The firm offers expertise in areas such as orphan drugs, biologics, medical devices, clinical trial management, safety and vigilance, market access, and regulatory strategy. Operating in seven locations across three continents, VCLS serves a wide range of healthtech developers and investors to optimize product development and ensure successful market entry.

📋 Description

• Define and lead phase-appropriate global CMC strategies across modalities for a diverse range of global clients • Provide thought leadership to raise the VCLS profile, including speaking at conferences, presenting webinars, and meeting VCLS clients • Enable our clients’ development of biologics, oligonucleotides, combination products, and cell & gene therapies • Guide scalable manufacturing and analytical strategies • Write and review technical documentation, and provide input and support for CMC team members • Oversee IND, CTA, BLA, NDA, MAA, and IMPD CMC documentation • Represent CMC in health authority interactions • Manage external partners, including external auditing and consulting partners • Drive performance and issue resolution • Lead and develop a team of 5–10 staff • Build a high-performing and collaborative culture • Partner with Regulatory, non-clinical, clinical, and business development teams to bring phase-appropriate solutions to VCLS clients and build the VCLS business

🎯 Requirements

• Degree in a relevant scientific discipline • Significant industry experience in CMC and drug development • Expertise across biologics, oligonucleotides, combination products, and cell & gene therapies • Experience managing mid to large teams • Strong regulatory submission experience (US and/or UK/EU) • Knowledge of GMP and global regulatory requirements • Experience with CDMOs