QUALITY CONTROL SUPERVISOR - PHARM TESTING/RAW MATERIALS 

PTx is devoted to developing and commercializing medicines and combination therapies that can make a meaningful difference in the lives of patients with cancer and other serious diseases. We are united in our passion for improving the treatment of cancer and other diseases 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 Northpointe (NP) 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. PTx is a small company full of opportunities and ambition and we need outstanding people to join our team to help realize our mission.

The Quality Control Cell Biology, Product Testing and Raw Materials group (CPR) supports the raw material, bulk drug substance (API), drug product and in-process monitoring programs of the production facility and support areas.  The group supports manufacturing activities at the Northpointe Facility through testing and release of finished drug product and the analysis and confirmation of the suitability of both the raw materials used in the manufacture of product and in-process materials generated during the different stages of the manufacturing process. The QC CPR group routinely interacts with production, engineering, validation, materials management, procurement, quality assurance and other QC groups.

POSITION OVERVIEW/KEY RESPONSIBILITIES:

This individual will report to the QC CPR Manager at the Northpointe Facility. This position provides departmental leadership and is responsible for testing and compliance support activities of the QC department while providing scientific expertise and support to Manufacturing and Quality operations on-site.

 

Specific responsibilities include:

  • Oversight of daily operations of QC PT/RM lab, supporting testing service needs for Manufacturing, Validation, Engineering & other Quality groups as needed

  • Lead QC team supporting effective, collaborative interactions with other departments including Manufacturing, Validation, Engineering, Materials, Finance, HR other Quality groups

  • 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 Drug Product, Bulk Drug Substance, In-Process and Raw Materials program(s)

  • Oversees sampling and laboratory testing execution ensuring timely results produced meet quality standards and requirements

  • Review SOPs and ensure concurrency with cGMP regulations and requirements

  • Review emerging and updated regulations and guidelines, stay current on industry trends and develop and implement gap remediation strategies to QC Manager, as necessary

  • Review and audit documentation to ensure accuracy, specifications and GMP Compliance

 

Additional Responsibilities include:

 

Management

  • Provide leadership and direction to the QC CPR team and support teams to ensure KPIs are consistently met while demonstrating and embodying PTx leadership values

  • Track and analyze QC CPR KPIs and key metrics and work with QC Management to measure, analyze and improve team performance

  • Provide development and coaching to direct reports to achieve their potential and meet site and individual goals

  • Manage, motivate and develop performance of direct reports by setting clear “SMART” goals, provide timely performance feedback and hold reports accountable for underperformance

  • Ensure timely issue escalation to Quality management and cross-functional support teams

  • Work with HR and  recruiters to maintain staffing levels and meet approved hiring plans, conduct performance and career development reviews for all direct reports

 

Training / Compliance / Deviations

  • Ensure projects are managed in compliance with all PTx, regulatory and legal requirements

  • Ensureall QC CPR lab operations meet current CGMP and PTx compliance requirements

  • Manage execution and support design of Department Training Plan(s)

  • Support Investigations and CAPA for major and critical deviations

  • Ensure all departmental deviations and lab investigations are closed in a timely manner

  • Support inspections conducted by internal and external agencies and develop responses according to specified timelines.

  • Support Inspection and audit readiness preparations for lab operations and staff

  • Comply 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

 

Production

  • Supervise operations in the QC PT/RM Lab

  • Communicate assigned task and provide day to day direction and scheduling to staff

  • Represent the functional lab area in meetings and compliance activities

  • Analyze testing data and write and/or review trending reports, as required.

  • Coordinate and support validation, engineering and production assignment according to manufacturing schedule without compromising quality

  • 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 CPR group in responses to facility issues.

 

Continuous Improvements

  • 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.

Leading People

  • 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.

BASIC QUALIFICATIONS:

  • Bachelor’s Degree; Chemistry / Biochemistry / Biology / Cellular Biology

  • 6 years QC and/or laboratory experience in a cGMP Manufacturing Environment or equivalent 

  • Effective scientific / technical knowledge with QC laboratory 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

PREFERRED QUALIFICATIONS:

  • 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:

  • Must be able to gown and gain entry to manufacturing areas

Please contact Brooklyn Borges at brooklyn.borges@partnertx.com or 425-245-1498 for all inquires 

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Lexington, MA 02421

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