Associate Director, Technical Services

Cosette Pharmaceuticals, Inc. is a US-based, fully integrated pharmaceutical company with capabilities in product development, manufacturing, and commercial operations. Cosette has a fast-growing portfolio of branded pharmaceuticals consisting of products in the cardiology, women's health, and migraine markets. Cosette has a long history in quality manufacturing of complex dosage forms including topical creams, ointments, oral liquids/solutions and suppositories, which has led to consistent supply to customers and commercialization success. Cosette has corporate and manufacturing facilities in New Jersey and North Carolina and is supported by more than 300 dedicated employees across all functional areas. Innovating every day.™ Reporting directly to the Vice President Technical Services and 3rd Party Operation, the Associate Director, Technical Services provides scientific and technical leadership for Cosette's commercial product portfolio and external manufacturing network. The role leads technology transfer, lifecycle management, manufacturing and packaging process changes, technical investigations, validation strategy, process optimization, and ongoing technical support for products manufactured through third-party CMOs/CPOs. The Associate Director serves as the primary Technical Services leader within Scientific Affairs and partners closely with Analytical, Regulatory Affairs, Quality, Operations, Supply Chain, Alliance Management, Strategic Sourcing, and external manufacturing partners. The Associate Director is expected to ensure that technical decisions affecting commercial products are scientifically sound, appropriately documented, compliant with regulatory expectations, and implemented effectively while supporting reliable product supply and business objectives. Technical Services is accountable for scientific and technical leadership supporting commercial products, while Operations retains accountability for manufacturing execution and supply continuity. The Associate Director is expected to work in close partnership with supply chain so that technical strategy and manufacturing execution remain fully aligned. KEY RESPONSIBILITIES Technology Transfer Leadership Lead end-to-end technology transfer activities for acquired products, new or alternate manufacturing sites, packaging sites, and other product transfers. Establish transfer strategies, technical requirements, risk assessments, validation approaches, acceptance criteria, project milestones, and readiness expectations. Coordinate formulation/process knowledge, equipment capability, raw materials, packaging components, validation, stability, regulatory requirements, and manufacturing readiness. Proactively identify technical risks, dependencies, and decisions requiring escalation and ensure transfers progress according to approved timelines. Provide ongoing scientific and technical leadership for Cosette's commercial portfolio and serve as a primary escalation point for complex manufacturing, packaging, and product-performance issues. Partner with Operations and external manufacturing organizations to determine root causes, develop technically appropriate solutions, and implement sustainable corrective and preventive actions. Product Lifecycle Management Lead the technical assessment and implementation of lifecycle changes affecting approved products, including API and raw-material changes, specifications, manufacturing and packaging processes, components, equipment, manufacturing site transfers, shelf-life extensions, process improvements, and cost-improvement initiatives. Ensure changes are supported by appropriate scientific rationale, risk assessment, comparability strategy, validation, stability, and regulatory evaluation. Technical Investigations, Deviations & CAPA Provide technical leadership for scientifically complex deviations, investigations, OOS/OOT events, manufacturing failures, recurring process issues, and product complaints requiring techni…

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