Scientist, Upstream cGMP Manufacturing

Organization
Catalent Pharma Solutions
Job Location
Madison, WI
Job Description

This position will perform a variety of laboratory procedures in cGMP Manufacturing. The position will perform daily work assignments accurately and in a timely and safe manner. The position will serve as a lead for technical advice and perform multiple complex projects at a time.

Primary Location
United States-WI-Madison

Organization
Advanced Delivery Technologies (ADT)

Schedule
Full-time

Requirements:
Qualifications

- Ph.D. in Biotechnology, or related field with at least 2 years of laboratory experience

- MS in Biotechnology, or related field with at least 3 years of industry laboratory experience

- B.S/B.A. in Biotechnology, or related field with at least 5 - 8 years experience in a laboratory environment

- Associates Degree/Certificate/D?iploma? in laboratory science with minimum of 7 years experience in a laboratory

Experience:

- Aseptic technique experience

- Mammalian cell culture experience is preferred

- cGMP documentation and experience

- Experience writing standard operating procedures

- Experience mentoring junior staff regarding laboratory procedures

Knowledge/Skills Requirements:

- Demonstrates a solid understanding of multiple applicable techniques such as:

o Responsible for performing purification process steps including aseptic processes, buffer preparation, chromatography and filtration steps

o Ability to execute, document, and schedule cGMP manufacturing activities

o Ability to operate within a clean room environment

o At least 5 years experience operating, maintaining, and troubleshooting stirred vessel bioreactors, incubators, chromatography columns, filtration apparatus and proven purification expertise with varied proteins

- Ability to cross-train on techniques across multiple groups

- Communicate effectively and follow detailed written and verbal instruction; ability to clearly communicate and provide mentorship to other groups and clients as necessary

- Ability to peer review data to ensure data is well organized with complete documentation

- Ability to interpret data, analyze trends and provide insight into potential issues and subsequent solutions

- Proficient in the operations of a computer with MS-Excel, MS-Word as well as programs for multiple pieces of laboratory or manufacturing equipment

- Positive attitude and ability to work well with others as a technical lead

- Ability to write SOPs and reports independently

- Ability to complete investigation, deviation, and change control forms independently...cont

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