Job Description
External Manufacturing Small Molecule Drug Substance Technical Lead, CTO
Our Small Molecule Technical Operations Unit is seeking a highly motivated individual to fill an open Senior Manager, to support drug substance manufacture within our External Manufacturing Network. This is an exciting opportunity to work with key strategic external partners, contribute and enhance technical experience in drug substance manufacturing, and work on high visibility network initiatives. Our team strives to provide technical excellence in our work and be solid partners, collaborators, and leaders within the small molecule line of business at our company.
Our team of chemists and engineers help ensure that external manufacturing operations remain operational, continuously improve and innovate.
Primary responsibilities for this position include, but are not limited to, the following:
Lead and act as the primary interface on technical issues between technical operations and the external partner.
Provide technical leadership within the technical operations group for the commercialization and manufacture of drug substance.
Provides technical guidance to the external partner, assesses viability of technology in proposed process configurations, verifies adherence to required standards, and ensures deliverables are technically sound.
Collaborates with external manufacturing operations, external quality, regulatory, and others to evaluate external partner(s) performance, fostering pro-active risk management mindset and continuous improvement
Executes technical due diligence assessments at external partner(s).
Ensures tech transfers are positioned for successful business outcomes. Executes technical transfers and receiving site readiness activities.
Executes validation strategies for new and existing products.
Provides manufacturing process support to external partner(s) to resolve production issues and to provide guidance on process and capacity optimization.
Supports/coordi