Senior Specialist, Biologics Downstream Operations

Job Description

Job Description: 

We are seeking an experienced and motivated scientist/engineer to join the Biologics Downstream Operations team within BioProcess Research and Development (BPRD). The successful candidate will be charged with operations leading downstream pilot plant activities, including fed-batch, antibody-drug conjugate processing and continuous processing operations. The candidate may have the opportunity to identify operational improvements to increase efficiency, respond to non-standard requests, or implement new technology and update laboratory procedure documents to standardize the improvement. Candidate is expected to work in a team atmosphere in close collaboration with bioprocess development scientists, facility engineering, lab automation and safety groups. 

The ideal candidate should have experience with small - scale and/or large - scale bioprocess equipment, including bioprocess chromatography skids, normal and tangential flow filtration techniques, viral filtration & inactivation techniques. The incumbent must be able to lead a small team (3-5 persons), work well with others, and communicate effectively both written and orally. Candidate may be requested to work during non-business hours/days to support extended growth and production activities. 

Candidate will participate in a range of activities including, but not limited to:

• Oversee purification activities for a range of biologics therapeutic molecules, including but not limited to mAb, fusion proteins, and antibody-drug conjugates.

• Facilitate knowledge transfers between development and operations teams.

• Batch documentation within an electronic laboratory notebook system.

• Participate in scheduling discussions within the operations team and scientists.

• Collaborate with development colleagues on the implementation of novel technologies and process analytical tools.

• Work collaboratively with pilot plant operations, upstream and solution prep teams.

• Work collaboratively with process development scientists from across BPR&D.

• Support safety and training initiatives.  

Education: 

• MS in Chemical/Biochemical/Biomedical Engineering/Biology/Chemistry with 5+ year or BS with 7+ years of hands-on industry experience

Required Experience and Skills: 

• Strong skills in laboratory experimentation and documentation, with demonstrated ability to write clear comprehensive operating procedures. 

• Solid hands-on experience with large scale purification operations 

• Ability to lead a team.

• Proven record of training peers.

• Strong communication and interpersonal skills to work in cross-functional team environments. 

• Strong troubleshooting skills.

Preferred Experience and Skills: 

• Experience with Bioprocess Skid and BioSMB

• Experience with Akta Ready/Flux

• Experience with Pendotech TFF System

• Experience with both fed batch and continuous processing.

• Experience with DeltaV, and Unicorn

• Ability to work with lab automation teams on improvement projects.

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