We areseekinga scientifically accomplished and visionary leader to serve asSenior Director, Analytical & Formulation Sciences (AFS). This roleis responsible fordirecting and overseeing formulation and analytical activities across processes, instrumentation, and laboratory operations, ensuring the delivery of high-quality biologics development fromearly-stagethrough commercialization.Ensures the effective use of material,equipmentand personnel while developing products and processes athigh qualitylevels.

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 capacityobjectivesas set forth by the VP, Analytical Formulation and Sciences.

• Evaluate,developand 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/equipment requirements to allowaccuratecontract pricing andappropriate performanceguarantees.

• Develop andmaintainbudgets,manpowerand capital requirements for formulation/analytical areas. Develop andmonitorperformance criteriaso as toallow 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,identifyprocess 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 meets objectives;guidethe professionalgrowth of team members by providing personal guidance and training relative to responsibilities.

Strategic & Operational Leadership

• 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.

Cross-Functional & Client Engagement

• 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, andidentifyprocess improvements

• Assess feasibility of development programs and align with facility capabilities, timelines, and cost structures

Operational & Financial Management

• 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

Lead, mentor, and develop a high-performing scientific organization

• Build a culture of innovation, accountability, quality, and customer focus

• Attract,retain, and grow top scientific and technical talent

Requirements:

Minimum requirement is a Bachelor of Science degree in a scientific discipline with a minimum of 17 years of technical management experience; or aMastersdegree with 15 years or a Doctorate degree in a scientific or biochemical engineering area (or equivalent) and 10+ years related experience and/or training preferred. Additionally, at least 5 years of experience serving in a relevant managerial capacityrequired.

Must have knowledge of GMPs and biotechnology-derived product regulations and be able to react to change productively and handle other essentialtasks asassigned.

• Also requires a demonstratedtrack recordin the following key areas:

• Attainment of aggressive growth and profit objectives

• Strong orientation for Quality and Customer Service

• Demonstrated level of respect for individuals

• Demonstrated contribution to science inappropriate area

• High levelof integrity and personal responsibility

• Record of innovation

• Strong collaboration and team building skills

• Proven leadership in analytical development within a CDMO or biopharma setting

• Deepexpertisein particle and biophysical characterization techniques and regulatory expectations

• Strong communication, project management, and client engagement skills

• Extensive experience characterizing cytokines, interferons, growth factors, monoclonal antibodies and conjugates, vaccines, viral vectors, and biosimilars
  

Salary Range: $189,000-$263,000