Biologics Manufacturing Project Lead
Newark Metro Area, New Jersey
- Biologics Drug Product Manufacturing Consultant - Project Management - Tech Transfer
The successful candidate will manage the manufacturing and clinical supply chain for a range of therapeutic protein products in clinical development
- 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 Biologics Development and Operations department, and with other Celgene 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 preferred. 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