Process Engineer – Technology Transfer

AppTec has a long history of providing biopharmaceutical contract testing services and has become one of the premier contract organizations offering biopharmaceutical manufacturing and testing services.  We are located in a new facility in Philadelphia at the Naval Business Center.

 

As a Process Engineer ? Technology Transfer in our Process Development group, you will be responsible for technical oversight during the transfer of technology from clients to AppTec.  This includes facilitating the transfer of technology from the clients to AppTec, coordinating the verification of the transferred process at AppTec and preparing a ?Technology Transfer report? summarizing Technology Transfer activities and results.  You will also be responsible for the internal technology transfer from Process Development to Manufacturing and coordinating the preparation of the Technology Transfer package.

 

You will provide technical support to Manufacturing during the first Toxicology / engineering run to insure proper tech transfer and scale up and provide additional technical support to internal departments as needed throughout the project period.  You will also be responsible for coordinating / monitoring technical activities for the project and working with the Project Manager and other functional departments within AppTec.

 

You will review Manufacturing Batch Record (BR) and track the progress of Process Development and other technical activities by providing periodic summary of the progress of the project to all functional departments.  You will also function as a technical liaison between clients and AppTec as a key member of the Project Team.

 

You will be responsible for providing Process Development input to large scale manufacturing runs and for collecting, reviewing and charting manufacturing run data and comparing with Process Development results.  You will provide a summary report on the performance of the scaled up manufacturing run.
You will also Identify the raw materials to be used and develop the associated commodity specifications for the identified raw materials working with internal departments.

BS in Engineering, Biological or Protein Sciences and 8 or more years of relevant experience in biopharmaceutical industry or equivalent training and/or experience are required.  In addition, qualified candidate must have hands on experience with large scale biopharmaceutical manufacturing in a cGMP environment and small scale process development - both upstream mammalian cell culture and downstream purification of therapeutic proteins / antibodies.

 

If you are interested in joining our dynamic team, e-mail your resume with salary requirements to: procengjobs.phila@apptec-usa.com .  We are an Equal Opportunity Employer. Direct applicants only - no agencies please. Visit us at: www.apptec-usa.com.