HEAD OF DRUG PRODUCT MFG AND DEVELOPMENT

 

Partner Therapeutics (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 being a cancer company begins and ends with the patient.  We strive to support patients throughout their treatment journey and offer therapy options that are right for them and their loved ones.

 

PTx has acquired worldwide rights to Leukine® (sargramostim).  As the only FDA approved GM-CSF available in the U.S., we believe Leukine offers important and differentiated benefits to cancer patients and are excited by the opportunity to effectively re-introduce it to the oncology community with its current label and future expansion indications.  Despite no commercial support for over a decade, Leukine is currently used in academic centers and group practices throughout the country.  There is significant scientific interest in Leukine with over 100 ongoing ISTs.

DEPARTMENT DESCRIPTION

PTx is seeking a qualified candidate to oversee drug product manufacturing and development activities including label and packaging, at multiple contract manufacturing organizations (CMO).  Job responsibilities include, overall life cycle management of DP’s, responsibility for partner evaluation and selection, insuring the appropriate DP capacity and flexibility is in place, 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.

PTx has locations in both Lynnwood, WA and Lexington, MA. This position could be based at either site and will require travel to current and future external CMO facilities in North America and possibly elsewhere. 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. This position will report to the SVP of supply chain.

KEY RESPONSIBILITIES:

Lead a cross-functional team (CMO QA, QA, QC, Validation, Supply Chain, Regulatory, Finance and Manufacturing) to ensure an uninterrupted product supply for key products manufactured at CMO’s.  Ensure processes and manufacturing operations at the CMO’s are consistent and compliant with established quality standards and relevant regulatory requirements.  Support the selection of additional CMO’s and will lead Tech Transfer Teams throughout the planning and execution phases. 

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

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

  • Oversee process improvement initiatives including purchase of capital equipment

  • Support regulatory submissions related to the CMO

  • Be actively involved in the evaluation, selection and implementation of new DP and L&P CMO’s.

  • Lead the DP manufacturing strategy activities for all PTx products

This role currently has no direct reports to manage, but the ideal candidate must embody considerable leadership skills to be successful (including effective interpersonal and cross-functional communications both written and verbal, relationship building, agility and adaptability).

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. Demonstrated success in being able to work at C level and executive levels in order to recommend and gain agreement for required changes. Ability to create a vision and strategy for DP manufacturing and oversee implementation of what is agreed to.

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

  • Demonstrated experience in overseeing commercial label and packaging CMO’s

  • Experience in supporting Drug Supply Chain Security Act (DSCSA) compliance thru L&P CMO’s

  • Ability to work independently and collaboratively within a CMO environment

  • Ability to manage and support multiple projects and activities

  • Experience with process and product transfer activities

  • Demonstrated success in leading cross functional teams

  • 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

REQUIREMENTS

  • 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 protein purification, batch formulation, sterilization, depyrogenation, filtration, aseptic filling, lyophilization, label and packaging and visual inspection

  • Demonstrated experience and success in managing CMO’s

To be considered for the position, please send your resume to info@partnertx.com

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(781) 218-9394

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19 Muzzey Street

Lexington, MA 02421

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© 2017 Partner Therapeutics, Inc.