|This position is responsible for leading, identifying, and managing the activities required to manufacture clinical and commercial drug products and/or finished product in accordance with all internal and external regulations. This entails development of process operations, establishing appropriate suppliers and managing the technology transfer, scale-up and validation activities. This may include the planning and coordination of the drug product/finished product supply plan and/or drug products for formulation, fill/finish operations which may include labeling and packaging. In addition, this requires the managing of the internal and external resources needed to support these activities. (Internal resources may include managing exempt and/or non-exempt positions). This position is also responsible for ensuring cGMP compliance for all documentation, both internal and external, relating to these production operations including any supporting documents required for regulatory submissions. The individual in this position will also manage the validation activities related to drug substance and/or drug product manufacturing. On-site oversight of the manufacturing activities at the manufacturing sites may be required. This will require domestic and/or international travel.
This position requires a Master's (PhD degree preferred) in a scientific discipline or equivalent in a related field and 10+ years of relevant clinical/commercial pharmaceutical industry experience (8+ years with a PhD). Experience in drug product and finished product manufacturing, aseptically produced parenteral manufacturing and solid oral dosage form manufacturing operations, clinical supply, and managing external contractors and previous direct supervisory experience is also required. Commercial production experience is preferred.
|Cell Therapeutics, Inc.|
State or Province