KBI
Senior Director, Analytical & Formulation Sciences
USA - CO - Boulder · Director
Sponsorship not specified$189k-$263kDetected 5 days ago
ReactProject ManagementCustomer SupportResearchLeadershipCommunicationCollaborationAdaptability
About the role
- 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.
Responsibilities
- Evaluate, develop and implement new formulation technologies leading to process improvements and efficiency of operation.
- 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.
- 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
- 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.
- 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
Requirements
- 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:
- Proven leadership in analytical development within a CDMO or biopharma setting
- Deep expertise in particle and biophysical characterization techniques and regulatory expectations
Nice to have
- 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.
Skills
- Full responsibility for the direction of all assigned analytical and formulation activities.
- In cooperation with customer representatives, identify process improvements in all laboratory areas.
- 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
- Ensure delivery of high-quality, interpretable data using advanced analytical instrumentation and techniques
- Assess feasibility of development programs and align with facility capabilities, timelines, and cost structures
- Define and track performance metrics to ensure on-time, error-free delivery and continuous improvement
- Attract, retain, and grow top scientific and technical talent
- Attainment of aggressive growth and profit objectives
- Strong orientation for Quality and Customer Service
Compensation
- $189,000-$263,000
Benefits
- 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.
Equal opportunity
- KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force.
This listing is sourced directly from KBI's careers page and normalized into a canonical job model.