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Senior Lyophilization/Tech Transfer Process Engineer (cGMP – Fill Finish - Pharmaceutical) JD820672

JD820672

DPS is looking for an experienced Senior Process and Operations consultant to work with a pharmaceutical client in the Boston, MA area. Ideal candidates should have previous experience supporting fill/finish and lyophilization processes for clinical scale manufacturing and interacting with Contract Manufacturing Orgnizations (CMOs). This individual should have previous expertise working with lyophilization scale up at Experience at a GMP fill/finish site.

Category:
Engineer Process / Food / Dairy Science
Location:
Massachusetts
Years of Experience Req.:
7+
Date Posted:
15/06/2020
Days Remaining:
23
Employment Type:
Full-time
Education Level Req.:
Bachelors

Senior Lyophiliz440735.426253ation/Tech Transfer Process Engineer (cGMP – Fill Finish - Pharmaceutical)         JD820672

Lexington, MA area

 

Summary:

 

DPS is looking for an experienced Senior Process and Operations consultant to work with a pharmaceutical client in the Boston, MA area. Ideal candidates should have previous experience supporting fill/finish and lyophiliz440735.426253ation processes for clinical scale manufacturing and interacting with Contract Manufacturing Orgniz440735.426253ations (CMOs). This individual should have previous expertise working with lyophiliz440735.426253ation scale up at Experience at a GMP fill/finish site.

 

Responsibilities:

  • Act as a drug product contract manufacturing technical expert and leader to provide leadership and solutions when troubleshooting drug substance freez440735.426253ing/thawing, formulation, filling vials/syringes/devices, lyophiliz440735.426253ation, inspection, and transportation.
  • Provide process development expertise for commercial drug product processing in specific areas such as Sterile processing, Process Characteriz440735.426253ation, Tech Transfer and Validation.
  • Support commercial drug product manufacturing operations with technical evaluation of NC/CAPA, scale up, validation, and technology transfer.
  • Develop and troubleshoot drug product processes and transfer technology to external sites.
  • Identify and implement operational opportunities for current and new sterile operations.
  • Travel to domestic and international contract manufacturing sites as required.

 

Qualifications:

  • Minimum 7+ years’ experience in process and manufacturing within a GMP environment.
  • Advanced degree in a scientific discipline (preferably Chemical Engineering).
  • Experience with gene or cell therapy operations is strongly preferred.
  • Must have strong knowledge of lyophiliz440735.426253ation and scale up processes.
  • Project management skills including the ability to manage multiple projects and evaluate project resource requirements.
  • Strong knowledge of Quality systems, CMOs, and Tech Transfer.
  • Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion.
  • Excellent problem solving and communication skills with the ability to effectively report to senior management.
  • Detail oriented with excellent verbal and written communication skills.
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