Senior Director AFS
Listed on 2026-07-09
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Management
Operations Management, Regulatory Compliance Specialist, Project & Program Management
Job Summary
We are seeking a scientifically accomplished and visionary leader to serve as Senior Director, Analytical & Formulation Sciences (AFS). This role is responsible for directing and overseeing formulation and analytical activities across processes, instrumentation, and laboratory operations, ensuring the delivery of high-quality biologics development from early‑stage through commercialization. It ensures the effective use of material, equipment and personnel while developing products and processes at high quality levels.
The Senior Director will lead a multidisciplinary team of scientists and technical experts while driving innovation, operational excellence, and client success in a dynamic CDMO environment.
Key Responsibilities- Full responsibility for the direction of all assigned analytical and formulation activities.
- Execute research and development requirements by meeting or exceeding productivity, quality and capacity objectives as set forth by the VP, Analytical Formulation and Sciences.
- Evaluate, develop and implement new formulation technologies leading to process improvements and efficiency of operation.
- In cooperation with Quality Assurance, Finance and Commercial Development, evaluate feasibility/assess risk of implementation of project development processes.
- Specifically review product/process development and manufacturing operations for adaptability with existing facility configuration. Develop preliminary schedules along with material, personnel and equipment requirements to allow accurate contract pricing and appropriate performance guarantees.
- Develop and maintain budgets, manpower and capital requirements for formulation/analytical areas. Develop and monitor performance criteria so as to allow measurement and continuous improvement of efficiency and quality, thereby ensuring meeting of committed targets of on‑time and error‑free performance.
- In cooperation with customer representatives, identify process improvements in all laboratory areas.
- Provide facility expansion support as needed by Facilities Engineering to meet expansion timeline and cost requirements.
- Lead, assess, coach and develop departmental associates. Manage performance; ensure team meets expectations and objectives; guide the professional growth of team members by providing personal guidance and training relative to responsibilities.
- Provide full leadership and direction of all analytical and formulation activities across the AFS organization.
- Establish and execute strategy for analytical lifecycle management and product development from early phase through commercialization.
- Ensure effective use of materials, equipment and personnel to meet productivity, quality and capacity objectives.
- Scientific & Technical Excellence.
- Oversee analytical characterization and formulation development for complex biologics (e.g., monoclonal antibodies, vaccines, viral vectors, cytokines.
- Ensure delivery of high‑quality, interpretable data using advanced analytical instrumentation and techniques.
- Evaluate and implement new formulation technologies to enhance process robustness and efficiency.
- Partner with Quality, Process Development, Regulatory, Finance, and Commercial teams to ensure successful program execution and risk mitigation.
- Collaborate with clients to define scope, deliver rapid‑turnaround testing, and identify process improvements.
- Assess feasibility of development programs and align with facility capabilities, timelines and cost structures.
- Develop and manage budgets, headcount planning and capital investment strategies for AFS labs.
- Define and track performance metrics to ensure on‑time, error‑free delivery and continuous improvement.
- Support facility expansion and infrastructure planning as People Leadership.
- Build a culture of innovation, accountability, quality and customer focus.
- Attract, retain and grow top scientific and technical talent.
Minimum requirement is a Bachelor of Science degree in a scientific discipline with a minimum of 17 years…
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