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.  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/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 meets objectives; guide the professional growth 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, and identify process 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 a Master’s degree 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 capacity required.  

Must have knowledge of GMPs and biotechnology-derived product regulations and be able to react to change productively and handle other essential tasks as assigned.  

• Also requires a demonstrated track record in 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 in appropriate area  

• High level of integrity and personal responsibility  

• Record of innovation  

• Strong collaboration and team building skills  

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

• Deep expertise in 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