Senior Director, Analytical & Formulation Sciences

About this role

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   thro ugh 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 professiona l   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-Funct ional & 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

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national

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