QUALITY CONTROL SUPERVISOR BIOLOGICS & FACILITY TESTING
PTx is devoted to developing and commercializing cancer medicines and combination therapies that can make a meaningful difference in the lives of cancer patients. We are united in our passion for improving the treatment of cancer and our desire to make a meaningful contribution to outcomes. We believe that innovation is not enough. In today’s challenging healthcare climate, we strive to develop and assess our products based on the real-world impact they have in improving the quality and duration of our patients’ lives. We measure our success in the birthdays, anniversaries, and other important life moments that our patients are able to enjoy.
PTx has recently acquired global rights to Leukine (Sargramostim). Leukine is the only licensed FDA-approved GM-CSF, and PTx is investing in Leukine to position it for growth. With Leukine, PTx acquired its state-of-the-art manufacturing facility in Lynnwood and we are North of Seattle, just a few minutes from downtown (but far enough out of, traffic and high cost of living in the city!). We are an established team with a renewed energy to seize on an exciting opportunity. To get there we need outstanding people to join our team of talented, innovative and committed professionals.
The Quality Control Biological and Facilities Testing group supports manufacturing activities at the Northpointe Facility by detecting, quantifying and identifying possible contaminants that may interfere with the quality of the product during the different stages of the manufacturing process. The group supports the environmental and critical utility monitoring program of the production facility and support areas. The QC BFT group performs key microbiological assays supporting BDS, cell bank and drug product release. The QC BFT group routinely interacts with production, engineering, validation and other QC groups.
POSITION OVERVIEW/KEY RESPONSIBILITIES:
This individual will report to the QC BFT Manager at the Northpointe Facility. This position provides departmental leadership and is responsible for activities of the QC department while providing scientific expertise and support to Manufacturing and Quality operations on-site.
* Support a safe, efficient, functional and compliant laboratories testing operations developed in accordance with site, corporate and regulatory guidelines
* Provide analytical expertise and support for product investigations, continuous improvements, etc. to ensure continued compliance with regulations
* Develop and implement Quality Control laboratory systems that support metrics / data trending, management review, subcontractor qualification and audits for Leukine testing
* Oversight of departmental training program
* Oversight of departmental deviations/CAPA, change controls and laboratory investigations
* Support, execution and continuous improvement for Raw Materials program
* Oversight of daily operations of QC lab, supporting testing service needs for Manufacturing, Quality, Validation & other groups as needed for
* Effectively lead QC team supporting effective, collaborative interactions with other departments including Manufacturing, Validation, Engineering, Materials, Finance, HR other Quality groups.
* Providing leadership and direction to the QC BFT team and support teams to ensure KPIs are consistently met while demonstrating and embodying PTx leadership values
* Providing development and coaching to direct reports to achieve their potential and meet site and individual goals
* Managing, motivating and developing performance of direct reports by setting clear “SMART” goals, providing timely performance feedback and holding reports accountable for underperformance
* Recognizing and rewarding high achievers
* Ensuring timely issue escalation to Quality management and cross-functional support teams
* Working with recruiters to maintain staffing levels and meet approved hiring plans, conducting performance appraisals and career development assessments for all direct reports
TRAINING / COMPLIANCE / DEVIATIONS
* Ensuring projects are managed in compliance with all PTx, regulatory and legal requirements
* Ensuring all QC BFT lab operations meet current CGMP and PTx compliance requirements
* Utilizing quality systems and KPIs / QPIs to measure, analyze and improve team performance
* Manage execution and support design of Department Training Plan(s)
* Support Investigations and CAPA for major and critical deviations
* Ensuring all departmental deviations and lab investigations are closed in a timely manner
* Support inspections conducted by internal and external agencies
* Inspection and audit readiness preparations for lab operations and staff
* Complying with requirements from PTx’s Safety Program including Health and Safety regulations and OSHA requirements
* Ensure Personnel Protective Equipment is used in the laboratory area
* Ensure proper handling and disposal of chemical and reagents
* Stay current on industry trends and propose changes to QC Manager, as necessary
* Communicate assigned tasks, update direct reports schedule, provide day to day direction to staff
* Supervise operations in the QC BFT Lab
* Represent the functional area in meetings and compliance activities
* Analyze Environmental Monitoring and Utility Systems data and write and/or review trending reports, as required.
* Review and audit documentation to ensure accuracy, specifications and GMP Compliance
* Coordinate and support validation, engineering and production assignment according to manufacturing schedule without compromising quality
* Oversees sampling and laboratory testing execution to produce results in timely manner without compromising quality
* Review SOPs and ensure concurrency with cGMP regulations and requirements
* Coordinate method development, allocate appropriate resources, and ensure work is concurrent with cGMP regulations and requirements
* Maintain positive relationship and network effectively across sites and organizations
* Communicate with other groups on issues in the facility that would compromise the validated or classified state of the environment and determine appropriate corrective actions. Direct QC BFT group in responses to facility issues.
* Track QC BFT KPIs and work with QC Manager on appropriate actions if KPIs are not routinely met.
* Work collaboratively with inter-department and cross-functional teams to lead improvement implementations in a timely, effective and compliant manner
* Identify and prioritize implementation of opportunities to improve Quality processes and practices
Ensure Quality management tools/systems and documentation (SOPs, MBR's, OJTs) are accurate and compliant
*Key responsibilities may differ among employees with the same job title and may change over time, in accordance with business needs.
* PTx’s leaders motivate, inspire, build, and retain highly effective teams. They manage for high performance and provide timely developing and coaching. They are versatile learners, focused problem solvers and courageous decision makers.
LEADING THE BUSINESS
* PTx’s leaders are effective operating in an evolving, complex and dynamic environment. They provide clear direction and instruction to direct reports and teams and continuously identify internal and external best practices and opportunities for improvement.
DELIVERING TO CUSTOMERS
* PTx’s leaders understand patient and customer needs and build goals and relationships to ensure their needs and site goals are both met. They create a vision for the organization while continuously improving operations through accountability to high performance standards.
* Bachelor’s Degree; Microbiology/Biology/Chemistry/Biochemistry
* 6 years QC and/or laboratory experience in a cGMP Manufacturing Environment or equivalent
* Effective scientific / technical knowledge with environmental monitoring and utility testing
* Proficient in MS Office and lab based data management systems
* Scientific technical writing ability
* Ability to present technical data
* Ability to coordinate scientific projects
* Experience troubleshooting and investigating assay and equipment issues
* Familiarity with USP and global compendial regulations
* Experience in a Supervisor or lab lead role
* Leadership skills, ability to drive accountability, compliance and efficiency throughout the department
* Good communication skills at individual, team and organizational levels
* Experience in team facilitation / project management experience
* Operational, developmental and compliance QC knowledge in fast paced lab environment
* Knowledge of quality management systems
* Ability to provide technical assay support for development / re-development / validation of current and/or new assays, as needed
SPECIAL WORKING CONDITIONS: ☒ N/A
* Must be able to gown and gain entry to manufacturing areas
Compensation and benefits are very competitive. They include a base salary, performance bonus, stock options and profit sharing. Our benefits include health, vision, dental and life INS, 401(k) with match & PTO
To be considered for the position, please send your resume to