Associate Director, Analytical and Formulation Science

KBI Biopharma•Boulder, CO

12d

About The Position

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.

Requirements

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.

Nice To Haves

Teams reporting to this role may deliver: 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.

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.
Oversee teams supporting product lifecycle activities including: 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.
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.
Generating concise technical reports and analytical data packages to support development teams and governance reviews.