MANAGER QUALITY CONTROL 

STABILITY, PHARMA TESTING, RAW MATERIAL, CELL BIOLOGY

 

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 Department is responsible for all standards and advanced quality control assay testing related to the manufacturing and release of Leukine to guarantee the product will meet the pre-defined standards for safety, purity, identity and effectiveness.  These activities include testing raw materials, process intermediates, and product, microbiological control of the utility systems and the manufacturing environment and oversight of all external contract testing.  The department is responsible for timely performance of this testing and oversight of supporting laboratory functions, data analysis and processing and documentation in compliance with procedures and cGMP regulations.  Additionally, this department works collaboratively with teams to perform method development, technical studies and investigation resolution.

 

POSITION OVERVIEW/KEY RESPONSIBILITIES:

This position provides key leadership and is responsible for direction of the QC department while providing scientific expertise and support to Manufacturing and Quality operations on-site.

Specific responsibilities include:

  • Support a safe, efficient, functional and compliant laboratories testing operations developed in accordance with site, corporate and regulatory guidelines

  • Manage stability program and oversee activities performed at contract testing site.  Design and generate protocols for special stability studies (e.g. syringe stability, photostability), coordinate studies with contract testing labs, write final reports, procure inventory and supplies.  Review stability data summaries, trend data, and disposition

  • Review release batch files and approve C of A’s

  • Preparation and/or review of AR and PPR sections

  • 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 Quality Control training program

  • Oversight of Quality Control deviations/CAPA, change controls and laboratory investigations

  • Support, execution and continuous improvement for Environmental and Critical Utilities Monitoring program(s)

  • 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. 

Additional Responsibilities include:

Management

  • Providing leadership and direction to Quality Supervisors, direct reports and support teams to ensure KPIs are consistently met while demonstrating and embodying PTx leadership values

  • Providing development and coaching to Quality Supervisors, direct reports and support teams to achieve their potential and meet site and individual goals

  • Managing 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 senior 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

  • Developing and managing department budget

Training / Deviations / Compliance

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

  • Ensuring all lab operations meet current CGMP and PTx compliance requirements

  • Utilizing quality systems and KPIs / QPIs to measure, analyze, and improve team performance

  • Designing and managing execution of Department Training Plan(s)

  • Manage Investigations and CAPA for major and critical deviations

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

  • Participating in 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

Continuous Improvements

  • Work collaboratively with inter-department and cross-functional teams to lead improvement implementations in a timely, effective and compliant manner

  • Identify 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

 

 

*This role currently has no direct reports to manage, but they must embody leadership skills to be successful (including effective intrapersonal and cross-functional communications both written and verbal, relationship building, agility and adaptability.

 

LEADERSHIP QUALIFICATIONS:

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 supervisors, 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 team’s accountability to high performance standards.

 

BASIC QUALIFICATIONS:

  • Bachelor’s Degree; Biology/Chemistry/Biochemistry

  • 3-5 years’ experience in a Manager or lead Supervisor role

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

  • Proven ability to efficiently lead a QC dept. responsible for all testing to release commercial product.

 

PREFERRED QUALIFICATIONS:

  • Strong leadership skills, ability to drive accountability, compliance and efficiency throughout the department

  • Experience in marketed product stability support

  • Good communication skills at individual, team and organizational levels

  • Effective team facilitator with project management experience

  • Operational, developmental and compliance QC knowledge in fast paced lab environment

  • Detailed knowledge of quality management systems

  • Effective scientific / technical knowledge of Microbiology, critical utilities, environmental monitoring testing

  • Ability to provide technical assay support for current assays and to lead troubleshooting / development / re-development / validation of current and/or new assays, as needed 

  • Ability to plan and manage budgets / projects

 

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 Brooklyn.borges@partnertherapeutics.com

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