Associate Director, Process Science (Onsite)

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 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 ofsemi-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 highperforming environment that enables team members to excel remain engaged and continuously enhance their impact while maintaining strong crossfunctional 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 nearterm objectives while strengthening longterm operational excellence.
• Partners closely with senior leadership and People & Culture to attract develop and retain diverse talent supporting thoughtful workforce planning and succession readiness.
• Drives performance management practices that include setting SMART goals providing timely and constructive feedback recognizing outstanding contributions and addressing performance gaps with accountability and care.
• Leads through coaching and example to uphold safety quality and compliance standards ensuring all team members possess the knowledge and skills required to support cGMP activities and adhere to applicable procedures and regulations.
• Creates meaningful development opportunities by supporting career pathing enabling crosstraining and proactively identifying and addressing competency gaps to strengthen overall team capability.
• Conducts regular GOOD 1:1 meetings and team forums to promote open dialogue reinforce priorities and maintain alignment on goals and expectations.

KNOWLEDGE SKILLS ABILITIES

Required:

• Demonstrated experience in protein purification using preparative HPLC including the application of multifactor DesignofExperiments (DOE) approaches to support process optimization and scientific decisionmaking.
• Ability to independently plan and execute laboratory studies in accordance with established standard operating procedures maintaining strong attention to detail data integrity and documentation quality.
• Prior experience leading or supervising technical teams with a collaborative leadership style that promotes effective communication and strong crossfunctional partnership.
• Welldeveloped analytical thinking and problemsolving skills with a demonstrated ability to evaluate complex situations and implement practical solutions that advance program and organizational objectives.
• Strong organizational and prioritization capabilities enabling effective management of multiple assignments while delivering highquality results within established timelines and resource parameters.
• Resourceful and relationshipfocused with the ability to build trust leverage internal networks and external partners and contribute positively within diverse and dynamic team environments.
• Clear and professional written and verbal communication skills in English with confidence participating in crossfunctional discussions sharing insights and seeking clarification when needed.
• Proficiency in Microsoft Office applications particularly Word and Excel along with the ability to quickly learn and apply additional rolespecific systems and tools.

Preferred:

• Experience with FDA Regulatory submissions
• Experience with semi-preparative chromatography of a protein drug substance
• Experience with HPLCs using Empower software control
• Experience using Unicorn and AKTA systems

PEOPLE LEADERSHIP QUALIFICATIONS

Required:

• Demonstrated ability to lead teams and projects effectively in complex evolving environments fostering a culture grounded in trust accountability compliance operational excellence and continuous improvement.
• Commitment to developing others through coaching active listening constructive feedback and thoughtful conflict resolution with a focus on building strong collaborative teams where individuals can perform at their best.
• Experience partnering with HR/People & Culture functions to support talent acquisition onboarding development engagement and retention initiatives.
• Working knowledge of structured interviewing practices with recent participation in hiring activities as an interviewer or hiring manager.
• Strong organizational awareness and relationship-building skills that support team engagement and contribute to a positive inclusive work environment.

Preferred Qualifications:

• Formal training in interviewing techniques and selection practices.
• Formal people leadership or management training including skill development in delivering and receiving feedback.

EXPERIENCE & EDUCATION

Required:

• PhD with 12 years of relevant industry experience.
• 5 years of experience in a People Leadership or Lead role. People Leadership qualification includes experience in recruiting making hiring decisions setting SMART Goals growing high performers and addressing performance concerns. Lead qualification includes time in a formal Lead role and/or leading project teams and/or collateral activity teams and participating on interview panels over an equal period of time.

PTx is committed to the principles of competitive and pay equity for all of our Partners. The current pay range for this position is $195000 - $215000: Offers are made within the base pay range applicable at the time. Your salary will vary depending on several factors including your qualifications and experience.

In addition to medical dental vision FSA/DCA HRA disability and life insurance coverage all full-time regular Partners enjoy a casual and Hybrid or Remote workplace program for many roles. We offer a terrific compensation/benefits/perks package which includes pre-IPO options annual cash bonuses 401k matching free parking or Seattle-area ORCA pass tuition assistance plus rewards for achievement and contribution. To support a healthy work-life balance we also provide a gym subsidy wellness participation programs and a generous vacation sick and holiday paid time off program in addition to a paid shutdown between the Christmas and New Years holidays.

Partner Therapeutics is an Equal Opportunity Employer and does not discriminate on the basis of race color religion sex age national origin veteran status marital status sexual orientation gender identity disability or any other category prohibited by local state or federal law. This policy applies to all aspects of employment including recruitment placement promotion transfer demotion compensation benefits social and recreational activities and termination.