Director Formulation Development Jobs in Golden, CO

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. 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.

• 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 to drive process improvements and operational efficiency.
• In collaboration with Quality Assurance, Finance and Commercial Development, evaluate feasibility and assess risk of implementing project development processes.
• Review product/process development and manufacturing operations for adaptability with existing facility configuration.
• Develop preliminary schedules with material, personnel and equipment requirements to support accurate contract pricing and performance guarantees.
• Develop and maintain budgets, manpower and capital requirements for formulation/analytical areas.
• Establish and monitor performance criteria to enable measurement and continuous improvement of efficiency and quality, ensuring on‑time and error‑free performance.
• Identify process improvements in laboratory areas in partnership with customer representatives.
• Provide facility expansion support to Facilities Engineering to meet expansion timelines and cost requirements.
• Lead, assess, coach and develop departmental associates; manage performance and guide professional growth through personal guidance and training.
• 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.
• Oversee analytical characterization and formulation development for complex biologics, ensuring delivery of high‑quality, interpretable data using advanced instrumentation and techniques.
• 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 them 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.

• Minimum of 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 with 10+ years of related experience (preferred).
• At least 5 years of experience serving in a relevant managerial capacity.
• Knowledge of GMPs and biotechnology‑derived product regulations; ability to respond to change productively and manage other essential tasks.
• Track record of attaining aggressive growth and profit objectives.
• Strong orientation for quality and customer service.
• Demonstrated respect for individuals and high level of integrity and personal responsibility.
• Demonstrated contribution to science in the relevant area.
• 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.

$189,000 – $263,000

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its workforce. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.