Senior Director, Analytical & Formulation Sciences

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, nati