Senior Director AFS

KBI Biopharma•Boulder, CO

About The Position

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.

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.
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.
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

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.
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.
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.
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.