Associate Director, Process Science (Onsite)

Location: Lynnwood,Washington,United States

POSITION SUMMARY

The Process Science Department is a group of scientists and subject-matter experts who design and conduct process and analytical development experiments in support of drug substance and drug product development. This position works with internal decision makers and external partners on unique scientific and technical issues and is a strategic leader for the downstream development efforts at PTx. This role leads a lab-based team that requires hands-on execution of downstream development, optimization and characterization experiments using small-scale chromatography models, and interpretation of experimental data for transfer into cGMP commercial manufacturing of drug substance. In addition, this role serves as a manufacturing SME with external partners for drug substance and drug product manufacturing initiatives.

PRIMARY RESPONSIBILITIES

• Serves as the technical authority for commercial API manufacturing, setting technical direction, driving continuous improvement, and ensuring long term process robustness.
• Sets the strategic direction for downstream process development from early development through commercialization and lifecycle management.  Develops and implements technical standards and best practices for robust downstream operations.
• Applies state-of-the-art principles and theory when designing studies that advance process development knowledge at benchtop scale for characterization, optimization, and/or transfer to manufacturing scale.
• Leads a team that contributes to strategic manufacturing objectives including project management of downstream projects and direct supervision of downstream research associate(s).
• Operation and maintenance of semi-preparative chromatography, membrane technology, and low-pressure chromatography (ion exchange, affinity, size exclusion) systems.
• Provides strategic downstream subject matter expertise and technical oversight for CDMO activities, guiding continuous process improvement, technology transfer, scale up, and lifecycle management to ensure robust and compliant operations.
• Provides strategic technical influence across Manufacturing, Quality, Regulatory, and Manufacturing Sciences to drive decisions that ensure long term process robustness and compliance.
• Leads the authoring and technical review of regulatory submissions related to downstream process improvements, scale up, process characterization, and post approval changes, ensuring alignment with global regulatory expectations.
• Proactively identifies and resolves complex or stalled issues by facilitating timely escalation and collaboration with leadership and cross-functional partners. Applies insights gained to strengthen systems, processes, and programs, reducing the likelihood of recurrence.
• Maintains current knowledge of industry trends, regulatory expectations, and emerging technologies through ongoing professional development, external networking, and participation in relevant professional organizations. Thoughtfully integrates best practices and benchmarking insights into projects and operational solutions.
• Contributes to or leads cross-functional initiatives and special projects beyond core responsibilities, supporting organizational priorities while fostering personal growth and broader connection across the business.
• Ensures full compliance with applicable regulatory standards and internal requirements, including adherence to SOPs, cGMP, health and safety expectations, OSHA guidelines, Company policies, and relevant employment laws.
• Completes all required Quality and Compliance training within established timelines, reinforcing a strong culture of accountability and operational excellence.
  

People Leadership:

• Provides strategic and operational leadership for the Downstream Process Development team, ensuring key performance indicators are achieved and leadership behaviors reflect PTx Values and Behaviors.
• Fosters an inclusive, high‑performing environment that enables team members to excel, remain engaged, and continuously enhance their impact while maintaining strong cross‑functional alignment across the organization.
• Defines clear individual and team objectives that support departmental priorities, monitors performance metrics, and ensures appropriate capability and capacity are in place to meet commitments.
• Plans and allocates human, technical, and financial resources to effectively deliver near‑term objectives while strengthening long‑term operational excellence.
• Partners closely with senior leadership and People & Culture to attract, develop, and retain diverse talent, supporting thoughtful workforce planning and succession r