Consultant Biologics Drug Product Manufacturing
Newark Metro Area, New Jersey
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 Biologics Development and Operations department, and with other stakeholders (Investigational Materials Supply Chain, Quality, Analytical Development/QC, Regulatory CMC, Commercial, and Clinical organizations).
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