Technology Transfer Specialist

 Summary:  This position is responsible for the preparation of documentation and reports in support of projects in Technical Services at a Scientist level.  Primary responsibilities include writing of protocols and reports, sampling, testing and monitoring of batches in addition to the coordination and scheduling of batches to meet timelines. 

 

Essential Duties and Responsibilities include the following. Other duties may be assigned.

Essential Function

Prepare documentation to support site transfer, alternate vendor submission and/or development batches, including but not limited to protocols, reports, process summary sheets etc.

 

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Perform blend sampling, in-process sampling and testing to support batch manufacture.

 

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Work with Operations to successfully manufacture and package batches.

 

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Participate and/or lead project teams as required.

 

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Organize and execute projects with little or no supervision.

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Able to implement change, increase productivity and enhance performance in response to ever changing business needs. 

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Train operations personnel on new technology, equipment or products to assure successful transfer from research to operations. 

ÖSupervisory Responsibilities:

None.

 Education and/or Experience:

·  Minimum B.S in Pharmaceutical Science, Engineering or Technology or equivalent.

· Minimum of 5+ years of Pharmaceutical Manufacturing or Technical Services/Validation/Process Development related experience.

 

To perform this job successfully, an individual should have:

·  Proficiency in running and setting up compression, blending, granulation, coating, drying and encapsulation equipment at both a Pilot and Manufacturing scale.

·  Proficiency in operating and maintaining both Pilot scale and Production scale equipment.

·  Working knowledge of cGMP’s and SOP’s.

·  Effective communication skills including written and verbal.

·  Strong computer skills including Word and Excel.

·  Good analytical, problem solving, organizational and training skills.

·  Some travel to alternate sites required as necessary.

 

 

Physical Demands/Work Environment The physical demands/work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.