Sr. Scientist, Downstream Process Science

Partner Therapeutics•Lynnwood, WA

1d•$140,000 - $165,000•Hybrid

About The Position

POSITION SUMMARY The Process Science Department is a group of scientists and subject-matter experts who conduct process and analytical development experiments in support of drug substance and drug product development. This position is primarily a lab-based role which requires hands-on execution of downstream development, optimization and characterization experiments using small-scale chromatography models, along with analysis and interpretation of experimental data for transfer into cGMP commercial manufacturing of drug substance. PRIMARY RESPONSIBILITIES Ownership of small-scale downstream purification development, including process optimization, characterization of parameters, and troubleshooting. Designs and performs lab studies using DOE methodology to advance process development knowledge at benchtop scale for characterization, optimization, and/or transfer to manufacturing scale. Project management of downstream purification projects and direct supervision of downstream research associate/s Hands-on operation and maintenance of semi-preparative chromatography, membrane technology, and low-pressure chromatography (ion exchange, affinity, size exclusion) systems. Provides downstream technical support for cGMP manufacturing operations by contributing insights to solve difficult technical issues and works to build alignment around complex situations. Authors documents to support regulatory filings and commitments. Effectively communicates and collaborates with scientists across the organization. Maintains high-quality and organized records and documentation. Resolves persistent issues by ensuring timely issue escalation to Leadership and cross-functional teams: Applies learning from these events and leads the creation of new/updated systems, processes, programs to prevent similar situations in the future. Through self-education and external networking/participation in industry and professional organizations keeps abreast of current industry trends, compliance requirements, and best-of-class technologies relating to area of responsibility. Actively applies learned best practices, knowledge, and benchmarking to PTx projects and solutions. Pursues participation or leads project teams outside normal course of work (i.e. “collateral duties”) as they become available to support personal growth, connection, and business needs. Adheres to all applicable regulations and requirements including compliance with internal SOPs, GMP, Health and Safety, WISHA/OSHA, regulatory compliance, company policies, and employment-related laws and statutes. Successfully completes all mandatory Quality and Compliance training within required timeframes. People Leadership: Provides leadership and direction to the Downstream Process Development team to ensure KPIs are consistently met while demonstrating and embodying PTx leadership values. Establishes individual goals and objectives in alignment with department goals and priorities. Identifies performance improvement targets and metrics. Ensures capabilities and capacity are in place to effectively deliver on all departmental commitments and performance targets Recommends and allocates resources - human, technical, etc. - to fulfill near term goals and commitments while building towards sustainable excellence. Builds, develops, inspires, motivates, and leads a diverse, professional team. Sustains high performance that is strongly aligned and coordinated with other functional groups across the organization; ensures Partner engagement by creating a culture of inclusion, execution, and an environment within which they can excel and continuously improve. Works pro-actively and in close collaboration with upline Leadership Team and People & Culture to recruit, hire, grow, and retain a diverse team of talent. Manages and develops the performance of direct reports by setting clear SMART goals, provides and seeks timely performance feedback, recognizes and rewards high achievers, and holds team members accountable for underperformance. Leads by example and promotes PTx’s core Values: Learn, Prepare, Innovate, Collaborate, Lead to continually improve the Quality Culture at PTx. Meets consistently with all Direct Reports in the GOOD 1:1 format and as a team to ensure 2-way updates, conversations, and alignment on goals and priorities are clear and reinforced regularly. Through active leadership and coaching, while embracing PTx’s Values and Behaviors, holds Team accountable for compliance to all safety and quality regulations, ensures all team members directly or indirectly support cGMP activities, and have the necessary education, knowledge, and skills to perform their job in accordance with applicable procedures and regulations. Pro-actively creates opportunities to develop their Team, including ensuring career paths have been developed for Partners (as needed), and enhances the Team through cross-training others, identifying competency gaps, etc.

Requirements

Experience with Protein Purification using Preparative HPLC
Experience with multi-factor Design-of-Experiments (DOE)
Detail-oriented with the ability to independently perform laboratory experiments following a standard operating procedure
Strong critical thinking, analytical, and problem-solving skills with the proven ability to formulate solutions to propel the organization forward.
Resourceful with proven ability to lead, manage, and leverage an extensive internal network of stakeholders, team members, and external resources to plan and resolve issues.
Strong, collaborative relationship management and interpersonal skills required to quickly gain confidence of stakeholders and team members.
Possesses strong organizational and prioritization skills to maintain a high level of productivity and priority-setting in order to complete assignments on-time and on-budget.
Excellent soft skills including a bias towards action, the ability and willingness to give and receive constructive feedback, is comfortable working within a diverse team and across multiple functions, exhibits a consistently constructive attitude, and is adaptable and at ease with handling unexpected changes and challenges.
Solid English language communication skills, both oral and written, are required for this highly collaborative role.
Willingness and ability to clearly express opinions and ask questions.
Comfortable actively participating in cross-functional meetings.
Proficiency with MS Office products, especially Word and Excel essential; ability and willingness to quickly adopt other job-specific applications will be necessary.
Proven ability to lead teams and/or projects effectively while operating in an evolving, complex and dynamic environment.
Demonstrated commitment to fostering the professional growth and development of others.
Knowledge of standard interviewing protocols; recent experience participating in the hiring process as an interviewer or hiring manager.
Strong leadership skills including a demonstrated ability to drive accountability and build a departmental culture of trust, compliance, efficiency, and continuous improvement.
Proven ability to enhance engagement by creating an environment within which individuals and teams can excel and continuously improve.
Skilled at active listening, conflict resolution, and team building.
Experience working collaboratively with HR/People & Culture functions to recruit, hire, grow, and retain talent.
Formal training in essential people management skills.
BS in Engineering or Chemistry with 12+ years of relevant industry experience; MS with 8+ years; or PhD with 5+ years of relevant industry experience.
2+ years of direct experience in People Leadership.
People Leadership qualification includes experience in recruiting, making hiring decisions, setting SMART Goals, growing high performers, and addressing performance concerns.

Nice To Haves

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
Training in fundamentals of Project Management
Formal interview training.
Formal people leadership training including development of giving-and-receiving-feedback skills.

Responsibilities

Ownership of small-scale downstream purification development, including process optimization, characterization of parameters, and troubleshooting.
Designs and performs lab studies using DOE methodology to advance process development knowledge at benchtop scale for characterization, optimization, and/or transfer to manufacturing scale.
Project management of downstream purification projects and direct supervision of downstream research associate/s
Hands-on operation and maintenance of semi-preparative chromatography, membrane technology, and low-pressure chromatography (ion exchange, affinity, size exclusion) systems.
Provides downstream technical support for cGMP manufacturing operations by contributing insights to solve difficult technical issues and works to build alignment around complex situations.
Authors documents to support regulatory filings and commitments.
Effectively communicates and collaborates with scientists across the organization.
Maintains high-quality and organized records and documentation.
Resolves persistent issues by ensuring timely issue escalation to Leadership and cross-functional teams: Applies learning from these events and leads the creation of new/updated systems, processes, programs to prevent similar situations in the future.
Through self-education and external networking/participation in industry and professional organizations keeps abreast of current industry trends, compliance requirements, and best-of-class technologies relating to area of responsibility.
Actively applies learned best practices, knowledge, and benchmarking to PTx projects and solutions.
Pursues participation or leads project teams outside normal course of work (i.e. “collateral duties”) as they become available to support personal growth, connection, and business needs.
Adheres to all applicable regulations and requirements including compliance with internal SOPs, GMP, Health and Safety, WISHA/OSHA, regulatory compliance, company policies, and employment-related laws and statutes.
Successfully completes all mandatory Quality and Compliance training within required timeframes.
Provides leadership and direction to the Downstream Process Development team to ensure KPIs are consistently met while demonstrating and embodying PTx leadership values.
Establishes individual goals and objectives in alignment with department goals and priorities.
Identifies performance improvement targets and metrics.
Ensures capabilities and capacity are in place to effectively deliver on all departmental commitments and performance targets
Recommends and allocates resources - human, technical, etc. - to fulfill near term goals and commitments while building towards sustainable excellence.
Builds, develops, inspires, motivates, and leads a diverse, professional team.
Sustains high performance that is strongly aligned and coordinated with other functional groups across the organization; ensures Partner engagement by creating a culture of inclusion, execution, and an environment within which they can excel and continuously improve.
Works pro-actively and in close collaboration with upline Leadership Team and People & Culture to recruit, hire, grow, and retain a diverse team of talent.
Manages and develops the performance of direct reports by setting clear SMART goals, provides and seeks timely performance feedback, recognizes and rewards high achievers, and holds team members accountable for underperformance.
Leads by example and promotes PTx’s core Values: Learn, Prepare, Innovate, Collaborate, Lead to continually improve the Quality Culture at PTx.
Meets consistently with all Direct Reports in the GOOD 1:1 format and as a team to ensure 2-way updates, conversations, and alignment on goals and priorities are clear and reinforced regularly.
Through active leadership and coaching, while embracing PTx’s Values and Behaviors, holds Team accountable for compliance to all safety and quality regulations, ensures all team members directly or indirectly support cGMP activities, and have the necessary education, knowledge, and skills to perform their job in accordance with applicable procedures and regulations.
Pro-actively creates opportunities to develop their Team, including ensuring career paths have been developed for Partners (as needed), and enhances the Team through cross-training others, identifying competency gaps, etc.

Benefits

medical
dental
vision
FSA/DCA
HRA
disability
life insurance coverage
casual, and Hybrid or Remote workplace program for many roles
pre-IPO options
annual cash bonuses
401k matching
free parking or Seattle-area ORCA pass
tuition assistance
rewards for achievement and contribution
gym subsidy
wellness participation programs
generous vacation, sick, and holiday paid time off program in addition to a paid shutdown between the Christmas and New Year’s holidays