SR. PROCESS ENGINEER

 

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 Northpointe Production group is seeking a qualified candidate to support drug substance and drug product manufacturing activities at multiple contract manufacturing organizations (CMO).  This person will report and resolve manufacturing issues as part of a multifunctional team and will act as the subject matter expert for resolution of manufacturing exceptions and CAPA’s.  Job responsibilities include periodic performance of data trending to ensure manufacturing is in a state of control, the identification of opportunities for improvement, the performance of periodic process performance reviews,  and the maintenance of operational control strategy (OCS) documents for network CMO’s.  This individual will lead multifunctional transfer teams.

The position will be based in Lynnwood, WA, and will require travel to current and future external CMO facilities in North America.  The candidate must have excellent working knowledge of the regulatory requirements for aseptic processing including the 2004 FDA Guidelines on Aseptic Processing as well as the 2009 EU EudraLex Volume 4, Annex 1 requirements. 

 

POSITION OVERVIEW/KEY RESPONSIBILITIES:

Work in cross-functional teams (CMO QA, QA, QC, Validation, Supply Chain, Regulatory and Manufacturing) to ensure an uninterrupted product supply for key products manufactured at CMO’s.  This individual will monitor and trend aseptic filling, capping, visual inspection and packaging operations as required.  A key responsibility will be to ensure processes and manufacturing operations at the CMO are consistent and compliant with established quality standards and relevant regulatory requirements.  This person will lead Tech Transfer Teams throughout the planning and execution phases. 

Specific responsibilities include the following:

  • Provide technical support and guidance for the design, scale-up, optimization, monitoring, and/or operation of the established manufacturing process validated at the CMO

  • Track and trend key process control elements (PCE), inputs, and yields to ensure current processes are in control and to identify opportunities to improvement

  • Perform periodic statistical analysis of trended PCE data and present data

  • Work with other SME’s to ensure data integrity is maintained and data is controlled

  • Oversee process improvement initiatives including purchase of capital equipment

  • Ensure compliance to standards and cGMP’s

  • Provide technical support at selected CMO.  This includes resolution of manufacturing deviations and implementation of approved CAPA.

  • Support regulatory submissions related to the CMO

 

*Key responsibilities may differ among employees with the same job title and may change over time, in accordance with business needs.

 

NO DIRECT REPORTS

 

LEADING PEOPLE

  • Motivate, inspire, and build highly effective teams while managing for high performance and developing others.   This individual is a versatile learner and a courageous decision maker.

 

LEADING THE BUSINESS

  • Operate in an evolving, complex and dynamic environment, providing clear direction and instruction to teams, and continuously looking internally and externally for best practices and areas for improvement.

 

BASIC QUALIFICATIONS:

  • BS or advanced degree in Engineering, Chemistry, Pharmacy or related Biological Science

  • 10-15 years’ experience in a manufacturing environment for therapeutic protein bulk manufacturing with specific knowledge of key unit operations including batch formulation, sterilization, depyrogenation, filtration, aseptic filling, lyophilization and visual inspection

 

PREFERRED QUALIFICATIONS:

  • Understanding of the principles and differences between conventional filling technologies and Advanced Aseptic Techniques

  • Understanding of the principles, equipment and qualification requirements for formulation, sterile filtration and lyophilization processes

  • Understanding of the primary packaging components used in vial filling and how these components are normally processed in a filling operation

  • Ability to review documentation describing pharmaceutical processes and provide insight into the technical as well as regulatory appropriateness of the process being described

  • Understanding of the concepts and regulatory requirements of various sterilization techniques including Steam, Vaporized Hydrogen Peroxide, Gamma Sterilization, Dry Heat, and Filtration

  • A basic understanding of the microbiological issues encountered in aseptic filling and the risk mitigation strategies and techniques employed to assure drug product sterility

  • Ability to work independently and collaboratively within a CMO environment

  • Ability to manage and support multiple projects and activities (Project Management skills)

  • Experience with process and product transfer activities

  • Lead GAP analysis, FMEA risk assessments and perform Root Cause analysis, as necessary

  • Demonstrated experience with design, execution and close out of process improvement studies

  • Experience in trending and statistical analysis

  • Excellent written and verbal skills

 

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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