Supply Chain Manager in Summit, NJ at Apex Life Sciences

Date Posted: 2/15/2018

Job Snapshot

Job Description


 Drug Product Manufacturing - CMO, Sterile, Aseptic, 

Job Description

The successful candidate will manage the manufacturing and clinical supply chain for a range of therapeutic protein products in clinical development 

  • Will interface with CMOs, Quality, supply chain, development and other partners to effectively manage scheduling, manufacture, release and logistics of investigational materials to support clinical trials. 
  • Will work with teams and be responsible for mfg. site selection, process fit, request for proposal and business operational documents (CDAs, DSAs etc.) 
  • Will work closely with drug product development group to support manufacturing process development, scale-up and technology transfer activities. 
  • Will interact effectively with members of the Biologic Development and Operations department, and with other stakeholders (Investigational Materials Supply Chain, Quality, Analytical Development/QC, Regulatory CMC, Commercial, and Clinical organizations). 

SKILLS AND KNOWLEDGE REQUIREMENTS: 

  • BS/MS in Pharmaceutical Sciences, Chemical Engineering or Biological Sciences with 2-5 years’ experience in Pharmaceutical industry, or equivalent. Ph.D. with 1-2 years’ relevant experience and interest in a manufacturing and operations career will also be considered. 
  • Experience in technology transfer and working with Contract Manufacturing Organizations (CMO) desirable. 
  • Experience in working in a cGMP environment desirable. 
  • Experience in clinical supply chain management and clinical packaging and labeling.
  • Strong desire to learn operational aspects of drug product manufacturing and supply chain required. 
  • Familiarity with sterile/biologic drug product manufacturing processes and unit operations from drug substance storage to secondary packaging is required. Familiarity with primary packaging (e.g., glass, non-glass materials) a plus. 
  • Knowledge of sterile drug product unit operations, aseptic / clean room technology and microbiology desirable. 
  • Working knowledge of statistics, data mining and trending for manufacturing process robustness analysis desirable. 
  • Familiarity with Global regulatory, cGMP, cGLP, and ICH requirements. 
  • Demonstrated skills in project management and handling multiple projects simultaneously 
  • Knowledge of global drug development process. 
  • Strong written and verbal communication skills, good interpersonal skills, ability to multi-task, and a strong desire to learn, contribute and collaborate 
  • *35% travel - both US and International

FOR IMMEDIATE CONSIDERATION, please:

  1. Send email to grucci@apexlifesciences.com 
  2. Put ' Drug Product Manufacturing' in the subject line

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 employeeservices@apexsystemsinc.com or 844-463-6178.