Associate Director, Analytical and Formulation Science

KBI Biopharma, Inc.; Boulder (CO); In loco; USD 152.000 - 209.000; Tempo pieno

Descrizione del lavoro

KBI Biopharma, Inc. seeks an Associate Director to lead Analytical & Formulation Sciences, overseeing development, validation, GMP testing, stability, and lifecycle management for biologics across development to commercial manufacturing.

You will manage a team of scientists, drive innovation, and ensure program success for multi-client projects. Responsibilities include cross-team collaboration, budget planning, and implementing new analytical technologies to enhance efficiency and scientific

Competenze

• 15+ years of technical management experience.
• Strong background in analytical development, GMP testing, biologics characterization, method validation, and stability programs.
• Knowledge of GMP regulations and biotechnology-derived product requirements.

Mansioni

• Lead analytical and formulation development activities across client programs.
• Mentor and develop a team of scientists while fostering accountability and collaboration.
• Execute departmental objectives supporting productivity, quality, capacity, and financial targets.
• Partner with Manufacturing, Quality, Process Development, Regulatory and Commercial teams.
• Develop budgets, staffing plans, and performance metrics.

Conoscenze

Analytical development

GMP testing

Biologics characterization

Method validation

Team leadership

Client engagement

Cross-functional collaboration

Formazione

BS in scientific discipline

MS in scientific discipline

PhD in relevant field

Strumenti

LC-MS

SEC

CE-SDS

IEX

icIEF

Descrizione del lavoro

Position Summary

The Associate Director, Analytical & Formulation Sciences provides scientific, operational, and people leadership for analytical development, characterization, testing, and support activities across biologics programs from early development through commercial manufacturing. This role leads a team of scientists and analysts responsible for analytical development, method validation, GMP testing support, stability programs, product characterization, and lifecycle management while driving operational excellence, innovation, and client success.

Key Responsibilities

• Lead analytical and formulation development activities across multiple client programs.
• Manage, mentor, and develop a team of scientists and associates while fostering a culture of accountability, collaboration, and scientific excellence.
• Execute departmental objectives supporting productivity, quality, capacity, and financial targets.
• Partner with Manufacturing, Quality, Process Development, Regulatory, and Commercial teams to ensure successful program execution.
• Develop budgets, staffing plans, capital requests, and departmental performance metrics.
• Evaluate, develop, and implement innovative analytical technologies and capabilities.
• Support proposal development, technical risk assessments, and client interactions.
• Champion best practices, continuous improvement, and cross-site alignment.

Analytical Development & GMP Testing Leadership

• Analytical method development, qualification, transfer, and validation.
• Stability-indicating method development and lifecycle management.
• Stability program design, execution, trending, and reporting.
• GMP analytical support for clinical and commercial manufacturing operations.
• Investigation support, OOS/OOT assessments, and technical troubleshooting.
• Release testing strategy and execution for drug substance and drug product programs.
• Product characterization and comparability assessments supporting process changes and regulatory filings.
• Implementation of new technologies, automation, and operational efficiencies within analytical laboratories.

Early-Phase Development Support

• Providing analytical support for upstream and downstream process development.
• Establishing fit-for-purpose methods for process understanding and rapid decision making.
• Supporting fermentation monitoring, product characterization, and purification development activities.

Typical Deliverables

• Method development, qualification, transfer, and validation reports.
• Stability protocols, testing, trending analyses, and summary reports.
• GMP release and in-process testing support for manufacturing operations.
• Product characterization packages utilizing LC-MS, SEC, CE-SDS, IEX, icIEF, and related technologies.
• Comparability studies supporting process, site, and manufacturing changes.
• Investigation support and analytical troubleshooting for manufacturing and quality events.
• Technical data packages supporting regulatory submissions and client deliverables.
• Early-phase analytical support for process optimization and characterization studies.

Qualifications

BS in a scientific discipline with 15+ years of technical management experience; MS with 13+ years; or PhD with significant industry leadership experience. Minimum 5 years of people leadership experience. Strong background in analytical development, GMP testing, biologics characterization, method validation, and stability programs. Knowledge of GMP regulations and biotechnology-derived product requirements. Demonstrated success in client engagement, team development, innovation, and operational leadership.

Leadership Attributes

• Quality-Focused: Delivers reliable, compliant, and scientifically sound results.
• Customer-Centric: Supports clients and manufacturing operations with urgency and accountability.
• Collaborative: Builds strong partnerships across functions and sites.
• Insight-Driven: Uses analytical science to inform decisions, improve processes, and accelerate program success.

Salary Range

$152,000-$209,000 plus bonus opportunity and comprehensive benefits.

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. At KBI, we are constantly seeking to improve our team with accomplished individuals who share in our commitment to serve our clients as they seek to advance important medicines to the patients who need them. We offer our employees a challenging, rewarding and fast-paced environment along with the opportunity for career advancement through the development of one’s technical skills. At KBI, employees work in a collaborative, team environment, where sharing knowledge and expertise with one another is strongly encouraged. If you do not see a position that matches your background, we invite you to return to our site often as positions are updated frequently.