Architecting the Blueprint from Concept to Scalable Drug Product.
Chemistry, Manufacturing, and Controls (CMC) is the technical backbone that determines the commercial and clinical viability of a therapeutic asset. At Livasyst, we recognize that CMC is more than a regulatory requirement, it is the definitive "story" of the product identity. As articulated by industry thought leaders, success in this domain requires a mastery of functional interdependencies.
We specialize in identifying the technical stewards - typically from the level of Principal Scientist to Head of CMC - who can synchronize the reciprocal relationship between Active Pharmaceutical Ingredient (API) synthesis, process development, and patient-centric formulation. In an era where CMC deficiencies account for nearly 20% of non-approval decisions, Livasyst identifies the talent capable of managing the "dimensionality explosion" encountered during scale-up, ensuring that the Phase III product administered to patients is identical to the one that eventually reaches the market.
Strategic oversight for 100+ specialized CMC and Technical Operations roles.
Vetting leaders who combine experimental depth with translational awareness.
99%+ placement rate for hard-to-fill MSAT and Regulatory CMC positions.
Strategic Leadership across Technical Operations & Formulation
Visionaries who optimize the interaction between API and excipients, ensuring bioavailability and stability in complex delivery systems like LNPs or autoinjectors.
The essential "bridge" leaders responsible for technology transfer, process validation, and ensuring manufacturing methods produce identical results across multiple global sites.
Specialists who translate complex technical data into a clear narrative for health authorities, authoring Module 3 CTD sections that accelerate the path to approval.
Executives who provide technical oversight of external manufacturing partners, mitigating risk and ensuring supply chain resilience for both clinical and commercial materials.
Leaders who define the Critical Quality Attributes (CQAs) and validated methods required to establish a roadmap for product Safety, Identity, Strength, Purity, and Quality (SISPQ).
Strategic architects who define the long-term CMC roadmap, manage multi-million dollar budgets, and drive cross-functional alignment with Discovery and Clinical teams.
A Methodology Informed by Scientific and Regulatory Rigor
We align your leadership search with specific pipeline milestones, from IND-enabling data packages to Phase II/III CMC briefing books.
Our consultants possess the technical depth to vet candidates on their patent history, structural characterization skills, and record of successful NDA/MAA filings.
Evaluating a leader’s "systems thinking" and their ability to manage the ripple effects that process changes in the lab have on global regulatory and commercial strategy.
We prioritize leaders with proven records in external manufacturing management, evaluating their history of CDMO selection and performance management.
Assessing a candidate's ability to champion "Quality as Responsibility," ensuring that compliance is embedded into the organizational culture, not just the oversight function.
Facilitating the onboarding of high-caliber "Scientist-Leaders" to ensure they are mission-ready to protect your asset’s license to operate.
Our Unique Advantages in CMC Recruitment
We vet candidates who understand that CMC defines the "Good" product (The Blueprint) while GMP provides the daily evidence of its execution (The Proof).
Livasyst excels in identifying scarce talent for next-generation modalities, including cell/gene therapy, mRNA platforms, and viscous product formulations.
We provide access to leaders who are fluent in the latest FDA, EMA, and ICH guidelines, proactively mitigating the risk of non-approval decisions.
Discreetly mapping the talent landscape to identify passive candidates with proven records in developing therapies and navigating regulatory pathways.
Let’s discuss your pipeline’s technical leadership needs and how we can identify the talent that will turn your molecular potential into a scalable reality.
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