External Quality Control Associate Manager

Location
19104, Philadelphia
Salary
Commensurate to Experience
Posted
May 13, 2021
Ref
KKP
Required Education
Masters Degree/MBA
Position Type
Full time

Piper Companies is seeking an External Quality Control Associate Manager in Philadelphia, PA to join a cell therapy leader committed to developing off-the-shelf cell therapies to expand patient access and provide an unparalleled opportunity to advance the course of cancer care.

 

 

Responsibilities:

  • Plan, schedule, coordinate shipping, and manage all outsourced QC testing and data in collaboration with process and analytical development, QC laboratory, and manufacturing teams
  • Review analytical method and qualification protocols/SOPs and executed testing certificates of analysis or reports for scientific and regulatory compliance
  • Work with contract testing laboratories (CTLs) to establish statements of work and quotes, as well as timelines and scheduling, for outsourced testing needs
  • Set up and manage sample/batch release and stability testing workflows in LIMS, issue certificates of analyses and stability reports for Quality Assurance review and approval
  • Document all CTL protocols, reports, COAs in internal quality management documentation database
  • Provide technical/troubleshooting support for CTL lab investigations and deviations with timely resolution and prepare in-house documentation
  • Track and report key performance metrics routinely to upper QC management
  • Ensure that the external QC activities comply with all relevant regulatory requirements, as well as support audits/inspections and author relevant sections of regulatory filing documentation

 

Qualifications:

  • BS or MS degree in a relevant biological, technical, or engineering field, with 10-12 years for BS, or 7-10 years for MS, of relevant professional experience. 
  • Prior experience in cGMP biopharmaceutical QC laboratory (cell therapy or biologics) testing
  • Strong working knowledge of current ICH, CFR, and GMP regulations and practices
  • Strong working knowledge of a variety of analytical testing platforms for biologics and/or cell-based therapies
  • Experience in SOP drafting, data review, and laboratory investigations/deviations
  • Experience with working with contract testing laboratories as both a technical subject matter expert and business operation lead
  • Excellent technical, communication, writing, and project management skills
  • Ability to lead and work independently with technical staff, both internal and external stakeholders