Biotechnology Engineer

Biotechnology Engineer
Location: Lexington, MA - onsite
Contract: 12 months duration                                                                                                                                                                                  Shift: M-F, 8am -5pm

Job Role Primary Duties:
As a key member of the Manufacturing Sciences – Commercial Manufacturing Support Laboratory group, this individual will be responsible for providing technical and scientific support of upstream, clarification and ultrafiltration processes for commercial production of Biologics, including process and product investigations/troubleshooting, continuous process improvement and life-cycle management, technology transfer and process validation. This individual may contribute as a member of various cross- functional teams and may interact with other departments including Manufacturing, QA, QC, PD, Engineering and RA.
Responsibilities:

• Assist in the design and execution of upstream experiments for process characterization to support technology transfer and continuous process improvements to improve robustness, capacity, and productivity.

• Provide technical expertise to plan, design and conduct experiments, analyze data, and document results.

• Provide high quality of written study proposals, research and development reports, and investigation reports.

• Provide technical expertise in troubleshooting and root cause analysis for process discrepancies and quality investigations of a complex technical nature
Education and Experience Requirements:
This individual will have a minimum of:
• A BS in Biochemistry or Chemical Engineering or related disciplines
• Minimum of 2 years' work experience in the biotechnology industry.
• Ability to work in a fast-paced environment with demonstrated capacity to juggle multiple tasks and demands.
 

Preferred Requirements:
• Hands-on experience in cell culture or depth filtration, ultra-filtration in lab or at manufacturing scale.
• Knowledge of GMP working environments
Key Skills, Abilities, and Competencies:
• Have basic knowledge of mammalian cell culture

• Independently design and execute cell culture experiments related to characterization of cell culture parameters

• Apply engineering principles in scaling up from bench to pilot plant or GMP manufacturing scale.

• Manage and maintain data in an organized manner. This includes keeping proper GLP lab documentation, authoring technical reports, tech transfer documents and preparing scientific presentations as needed.

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• Demonstrate teamwork/collaboration and the ability to communicate appropriately and effectively.

• Be customer focused, results oriented, science driven and embrace values.

• Have the attitude to proactively learn new technologies and manage changes in cell culture process development and improvement.