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Apex Life Sciences

Cell Therapeutic Supervisor (Cell Culture, Cell Processing, Clean Room, ISO, cGMP)

Post Date:Dec 29, 2017Type:Contractor
Start Date:12/29/2017Salary:
Location:US-NJ-Warren New Jersey Job Reference:803995
Skills:
 

Job Description:

Cell Processing Supervisor (Cell Culture, Cell Processing, Clean Room, ISO, cGMP)

Leading Biopharmaceutical is in search of a Cell Processing Lead company hiring multiple Cell Processing/ Manufacturing Associates for 5 advancement job opportunities; the new hires will utilize their knowledge of Cell Culture, Aseptic Processing, ISO, cGMP and GDP, to secure long-term full time employment within the growing Biopharmaceutical field! We are looking for skills, committed, positive, dynamic individuals looking for a long-term growth potential!!

Job Type: Full-time

Duties:

  • Act as a senior operator with supervisory presence in the production facility to guide and facilitate the manufacturing of products to support clinical and commercial timelines. 
    • Assume responsibilities as a lead operator for at least one product line, which includes serving as the primary GMP representative during early development and transfer activities. 
    • Leads the compliance efforts associated with at least two of the major areas of GMP compliance (i.e. Document Management, Batch Record Review, Nonconformance Reporting, Training, Facility Management, Equipment Qualifications/Maintenance, etc…) 
    o Responsible for systems maintenance, upgrades, and accuracy. 
    o Addresses related issues as necessary during internal audits. 
    o Promotes improvements in these areas to achieve greater process efficiencies. 
    • Assists with development, implementation, and deployment of training to new employees. 
    • Draft Standard Operating Procedures (SOPs) and/or production batch records associated with new processes that are transferred from Bioprocess Development into Manufacturing Operations 
    • Represents the department on cross-functional/interdepartmental teams tasked with complex projects 

  • Requirements:
  • B.S. in Biology, Biochemical, Chemical, or Biomedical Engineering or related discipline
  • Experience in a Supervisory or Lead role
  • Minimum of 5 years of relevant experience in a laboratory or Cell Culture Processing environment.
  • Minimum 1-3+ years hands-on experience with Cell Culture, Aseptic Processing, Clean Room, Sterile Gowning ISO, GMP, GDP
  • Proficient in Microsoft Office Suite and basic computer applications
  • Experience working in an Aseptic or Sterile Processing Environment, cGMP gowning, de-gowning environment
  • Experience in cGMP cell culture manufacturing, and cell therapy preferred.
  • Aseptic processing in ISO biosafety cabinets.
  • Cell expansion using incubators and single use bioreactors.
  • Cell washing, cell separation techniques and use of automated equipment.
  • Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.
  • Experience with SAP, Trackwise, etc. desired

Keywords: Cell Culture, Aseptic Processing, Clean Room, Sterile Gowning ISO, GMP, GDP, Manufacturing technician, production technician, biological manufacturing, bioprocessing, biotechnology manufacturing, biotechnology, cGMP, gowning, de-gowning, cell sorting, clinical, sterilization.

FOR IMMEDIATE CONSIDERATION, please:

  1. Send resume to: [Click Here to Email Your Resumé] 
  2. Put 'Cell processing Supervisor' in the subject line
  3. Or Give us a call @ 732-636-1497

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [Click Here to Email Your Resumé] or 844-463-6178.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [Click Here to Email Your Resumé] or 844-463-6178.





Contact Information
Apex Life Sciences



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