Associate Director, Technical Services

Cosette Pharmaceuticals Inc.•Bridgewater, NJ

2d•Hybrid

About The Position

The Associate Director, Technical Services provides scientific and technical leadership for Cosette Pharmaceuticals’ commercial product portfolio and external manufacturing network. Reporting directly to the Vice President Technical Services and 3rd Party Operation, 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 is 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 role ensures that technical decisions affecting commercial products are scientifically sound, appropriately documented, compliant with regulatory expectations, and implemented effectively in support of reliable product supply and business objectives. Technical Services provides scientific and technical leadership, while Operations remains accountable for manufacturing execution and supply continuity. The Associate Director works closely with Supply Chain to keep technical strategy and manufacturing execution aligned. The position also manages the integrated Technical Services project portfolio, annual budget and forecasts, and technical due diligence and integration work for potential acquisitions. The role follows a hybrid schedule requiring three onsite days per week at the Bridgewater, New Jersey office.

Requirements

Bachelor’s degree in Pharmaceutical Sciences, Chemical Engineering, Chemistry, Pharmacy, or a related scientific or engineering discipline.
Approximately 12 or more 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.
Strong knowledge of pharmaceutical manufacturing, scale-up, process validation, cGMP, investigations, change control, CAPA, stability, CMC, analytical methods, manufacturing and packaging processes, and FDA regulatory expectations.
Strategic and scientific thinking, with the ability to connect technical decisions to patient, supply, quality, regulatory, cost, and commercial outcomes.
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.
High ownership, accountability, transparency, and solution-oriented problem solving.

Nice To Haves

Master’s degree, PharmD, or PhD.
Experience with branded and/or complex pharmaceutical products.
Experience with post-approval lifecycle management.

Responsibilities

Lead end-to-end technology transfers for acquired products, new or alternate manufacturing sites, packaging sites, and other product transfers; define strategies, technical requirements, risk assessments, validation approaches, acceptance criteria, milestones, and readiness expectations.
Coordinate formulation and process knowledge, equipment capability, raw materials, packaging components, validation, stability, regulatory requirements, and manufacturing readiness for transfers.
Identify technical risks, dependencies, and decisions requiring escalation, and keep transfers progressing against approved timelines.
Provide scientific and technical leadership for the commercial portfolio and act 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 appropriate solutions, and implement sustainable corrective and preventive actions.
Lead technical assessment and implementation of lifecycle changes to approved products, including changes to APIs, raw materials, specifications, processes, components, equipment, manufacturing sites, shelf life, and cost-improvement initiatives.
Ensure lifecycle changes have appropriate scientific rationale, risk assessment, comparability strategy, validation, stability, and regulatory evaluation.
Lead technical assessment of scientifically complex deviations, investigations, OOS/OOT events, manufacturing failures, recurring process issues, and product complaints; work with Quality while maintaining clear distinctions between technical assessment and Quality System ownership.
Establish technical governance with CMO/CPO partners and review manufacturing performance, investigations, process changes, validation documentation, stability information, technical change controls, and manufacturing and packaging documentation.
Provide technical leadership for process and packaging validation, hold-time studies, cleaning-validation assessments, and continued process verification, as applicable.
Assess new or alternate API manufacturers, CMOs, CPOs, critical component suppliers, and manufacturing technologies, including capability, process compatibility, technical risk, transfer requirements, and scalability.
Identify and mitigate risks involving manufacturing robustness, single-source materials, APIs, components, equipment, process capability, external partner capabilities, transfers, and product lifecycle; develop contingency strategies and escalate material risks.
Partner with Regulatory Affairs to assess regulatory impact and support technical documentation for supplements, annual reports, Health Authority responses, and other submissions.
Partner with Quality to support cGMP compliance and quality-system execution while preserving independent Quality oversight and clear technical accountability.
Work with Operations and Supply Chain to identify, assess, and resolve technical risks that could affect manufacturing reliability, release readiness, or product availability.
Maintain an integrated Technical Services portfolio covering transfers, lifecycle projects, investigations, validation, CMO initiatives, product risks, regulatory commitments, milestones, priorities, owners, timelines, and resource requirements, in partnership with PMO.
Develop and manage the annual Technical Services budget and forecasts; provide spend visibility by product, project, and CMO; identify budget risks and recommend mitigation or reprioritization.
Support technical due diligence for potential product and company acquisitions, assessing processes, risks, external manufacturers, API sources, validation status, lifecycle requirements, capital needs, and transfer complexity.
Lead or support technical integration and transfer activities following acquisitions.
Provide people leadership, coaching, succession planning, and development of technical talent.