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 technical assessment. Work closely with Quality while maintaining clear distinction between Quality System ownership and scientific/technical assessment ownership. Ensure investigations are scientifically rigorous, identify credible root causes, and result in effective and sustainable CAPAs. CMO/CPO Technical Oversight Serve as a senior technical interface with Cosette's CMO/CPO network. Establish effective technical governance with external manufacturing partners and ensure timely review of manufacturing performance, technical investigations, process changes, validation documentation, stability information, technical change controls, and manufacturing/packaging documentation. Provide technical leadership for process validation, packaging validation, hold-time studies, cleaning-validation technical assessments, and continued process verification, as applicable. Ensure validation strategies are scientifically justified, risk-based, compliant, and appropriate for the product and manufacturing process. API, Supplier & CMO/CPO Selection Serve as a core member of cross-functional teams evaluating new or alternate API manufacturers, CMOs, CPOs, critical component suppliers, and manufacturing technologies. Lead or coordinate the technical assessment of manufacturing capability, process compatibility, technical risk, transfer requirements, and scalability. Technical Risk Management Proactively identify and mitigate risks involving manufacturing robustness, single-source materials, API, components, equipment, process capability, CMO capabilities, technology transfers, and product lifecycle. Develop mitigation and contingency strategies with cross-functional partners and escalate material risks in a timely manner. Regulatory & Quality Partnership Work closely with Regulatory Affairs to ensure technical changes are appropriately assessed for regulatory impact and that technical documentation supports supplements, annual reports, Health Authority responses, and other submissions. Partner with Quality to ensure cGMP compliance and robust quality-system execution while preserving clear accountability for scientific assessment and independent Quality oversight. Supply Continuity Support Partner closely with Operations and Supply Chain to provide technical support for supply continuity. Operations remains accountable for manufacturing execution and supply continuity, while Technical Services proactively identifies, assesses, and resolves technical risks that could affect manufacturing reliability, release readiness, or product availability. Portfolio, Budget & Resource Management Maintain an integrated Technical Services portfolio covering active technology transfers, lifecycle projects, technical investigations, validation activities, CMO technical initiatives, product risks, regulatory commitments, and critical milestones. Establish clear priorities, owners, timelines, risks, and resource requirements in partnership with PMO. Develop and manage the annual Technical Services budget and forecasts, provide visibility to spend by product/project/CMO, identify budget risks early, and recommend mitigation or reprioritization as needed. Business Development, Due Diligence & Integration Support technical due diligence for potential product and company acquisitions by evaluating manufacturing processes, technical risks, CMOs/CPOs, API sources, validation status, lifecycle requirements, capital needs, and technology-transfer complexity. Following acquisition, lead or support technical integration and transfer activities to ensure effective transition into Cosette's operating model.
PROFESSIONAL EXPERIENCE / QUALIFICATIONS
- Bachelor's degree in Pharmaceutical Sciences, Chemical Engineering, Chemistry, Pharmacy, or a related scientific/engineering discipline required; Master's degree, PharmD, or PhD preferred.
- Approximately 12+ years of progressive pharmaceutical industry experience, including substantial experience supporting commercial manufacturing, technology transfer, process validation, lifecycle management, and external manufacturing.
- Demonstrated experience working with CMOs/CDMOs/CPOs and leading complex technical programs across multiple products and manufacturing sites.
- Experience with branded and/or complex pharmaceutical products and post-approval lifecycle management strongly preferred.
- Strong knowledge of pharmaceutical manufacturing, scale-up, process validation, cGMP, investigations, change control, CAPA, stability, CMC, analytical methods, manufacturing/packaging processes, and FDA regulatory expectations.
JOB-SPECIFIC COMPETENCIES
- Strategic and scientific thinking with the ability to connect technical decisions to patient, supply, quality, regulatory, cost, and commercial outcomes.
- Strong business acumen and ability to balance technical risk, compliance, cost, timing, and supply priorities.
- Timely, data-driven decision making and effective technical risk management.
- Cross-functional leadership and influence across Scientific Affairs, Operations, Quality, Supply Chain, Regulatory, Alliance Management, and external partners.
- Executive-level communication of complex technical risks, recommendations, and decisions.
- People leadership, coaching, succession planning, and development of technical talent.
- High ownership, accountability, transparency, and solution-oriented problem solving.
Benefits
Hired applicants will be eligible for benefits, including but not limited to, medical, dental, vision, life insurance, short-term disability, long-term disability, 401(k) match, flexible spending accounts, health saving account, employee assistance program, tuition reimbursement program, parental leave, wellness program, paid time off, volunteer time, and holidays. Physical Requirements This role will follow a hybrid work schedule, requiring three (3) onsite days per week at our Bridgewater, NJ office.