ASSOCIATE DIRECTOR TECHNOLOGY SOLUTIONS

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 Technology Solutions Department is dedicated to providing high quality services and novel technical solutions to meet the business needs of the organization.  The department consists of two distinct workgroups, Automation and Information Technology (IT). The Automation workgroup develops, maintains, and improves automated control and data acquisition systems for biopharmaceutical manufacturing equipment and supporting utilities. The IT workgroup is responsible for design, implementation, support, and maintenance of IT solutions in support of manufacturing and corporate objectives.  Both groups are responsible for maintaining stable, qualified, and highly available computing infrastructure and associated applications. Additionally, through daily tasks, both groups support current project operations, provide end user support and ensure compliance with regulatory, corporate and site requirements.

 

POSITION OVERVIEW/KEY RESPONSIBILITIES:

The Associate Director, Technology Solutions is responsible for managing a group of staff technical professionals, ensuring execution of and availability of production and corporate systems, and managing staff performance against operational goals. 

Management:

  • Provide leadership and direction to support teams while embodying the principles of the corporate Leadership Model.

  • Managing and developing the performance of direct reports by setting “SMART” goals, providing timely performance feedback, recognizing and rewarding high achievers, and holding reports accountable for underperformance.

  • Ensuring timely issue escalation to senior management and cross-functional support teams.

  • Partnering with teams i.e., Manufacturing, Quality, Engineering, etc. to ensure adherence to schedules, while holding reports and teams responsible for compliance to all safety and quality regulations. Ensuring that appropriate levels of trained resources are available to meet client needs.

  • Working with recruiters to maintain staffing levels and meet approved hiring plans.

  • Conducting performance appraisals and career development assessments for all direct reports

  • Ensuring that a consistent technical approach for automation, infrastructure and application engineering is used across projects.

  • Mentor staff to ensure that the team applies compliant, efficient engineering solutions to projects.

  • Prepare departmental operating and capital budgets.  Develop and implement hardware and software life cycle management plans.

  • Exert influence in the development of overall objectives and long range goals of the organization.

 

PROBLEM SOLVING:

  • Provide technical solutions to a wide range of difficult problems through individual efforts as well as strategic leveraging of outsourced personnel including management of infrastructure and application support vendors.  Solutions are imaginative, thorough, practical and consistent with organization objectives.

  • Responsible for driving work plans and providing technical direction to staff that meet the short and long term business goals of internal functional areas.

  • Ensure that the works of individual information systems efforts are integrated into the corporate information strategy and architecture.

 

TRAINING/DEVIATIONS/COMPLIANCE:

  • Utilizing quality systems to measure, analyze, and improve team performance.

  • Lead staff meetings, providing updates of department activities and project statuses.

 

PARTNERING WITH DIRECT AND INDIRECT MANAGEMENT CHAIN TO PROVIDE THE FOLLOWING:

  • Designing of department training plan and managing its execution.

  • Ensuring inspection readiness of assigned areas.

  • Overseeing completion of investigations and deviations.

 

PARTNERING WITH QA TO PROVIDE THE FOLLOWING:

  • Ensuring all deviations and CAPA’s are closed in a timely manner

  • Oversight for deviations and department documentation changes

  • Ensuring that Automation and IT related documentation is compliant and inspection ready

  • Participating in inspections conducted by external regulators

  • Complying with requirements from corporate safety program including Health and Safety regulation and OSHA requirements

 

PRODUCTION:

  • Responsible for ensuring automation, quality relevant and business critical systems are available to support operations and production schedules

  • Overseeing departmental projects impacting production and ensuring that the appropriate approvals and validation requirements are implemented.

 

CONTINUOUS IMPROVEMENT:

  • Developing and implementing performance metrics for enterprise wide technology solutions

  • Working collaboratively with inter-department and cross-functional teams to lead necessary changes in a timely and productive manner

  • Partnering with client groups to troubleshoot and drive resolution of process issues and proactively driving projects to improve the impact of automation and IT solutions on all functions of the facility

  • Plays a proactive role in developing and applying new approaches to information management

 

LEADERSHIP QUALIFICATIONS:

  • Minimum 5 years leading direct reports

  • Experience developing personnel for higher levels of performance

  • Experience leading cross-functional teams

  • Experience developing and maintaining a culture of quality, safety and continuous improvement

  • Motivate, inspire, build, and retain highly effective manufacturing teams while managing for high performance and developing others. They are versatile learners and courageous decision makers

 

BASIC QUALIFICATIONS:

  • B.S. in Computer Science or Engineering related field or a combination of technical training and relevant work experience

  • Minimum 10 years as a practicing professional involved in the support, design, and/or implementation of network infrastructure, end user support systems and associated business support software solutions

  • Experience developing and managing operating expense and capital budgets

 

PREFERRED QUALIFICATIONS:

Working knowledge of process automation desired but not necessary, including:

  • Experience in the support, design, and/or implementation of industrial process control and data acquisition and archiving systems including familiarity with field I/O devices

  • Automated process experience including utility operations (pure water systems, compressed air, steam and clean steam, etc.), building automation systems (HVAC, dynamic room pressurization, chillers, etc.), autoclaves, CIP systems, fermentors, MF/UF, LC, HPLC and or other filtration systems

  • Control system software experience including Allen Bradley: ControlLogix, SLC500, RSView ME, PanelBuilder; GE Fanuc: iFix, iHistorian, RTIP, Proficy Change management

  • Preferred quality experience including performance in a cGMP manufacturing environment and a strong understanding of quality systems

  • Experience with computer software validation including familiarity with computer system life cycle management practices and Good Automation Manufacturing Practices (GAMP)

  • Experience implementing technical solutions on an enterprise wide basis

  • Experience with both on premise and cloud based infrastructure and business applications, including but not limited to Office 365 and SAP ERP. Experience in a regulated environment (Biotech, Financial, etc.)

  • CCNA, VMW, VCP and MCP certification or above

 

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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Lexington, MA 02421

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