Upstream Engineer

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, specifically on executing process characterization studies implementing ATF (alternative tangential filtration) using qualified scale down models. Job Function and Description75 % of Time - Assist in design and execution of continuous process improvements, aimed at improving robustness, capacity, and productivity, specifically on executing small scale or pilot scale studies to incorporate ATF perfusion to replace existing centrifuge process.

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, specifically on executing process characterization studies implementing ATF (alternative tangential filtration) using qualified scale down models. This individual may contribute as a member of various cross- functional teams and may interact with other departments within Client, including Manufacturing, QA, QC,
• PD, Engineering and RA.

Responsibilities
Job Function and Description

• 75 % of Time - Assist in design and execution of continuous process improvements, aimed at improving robustness, capacity, and productivity, specifically on executing small scale or pilot scale studies to incorporate ATF perfusion to replace existing centrifuge process. Provide technical expertise in identifying opportunities/areas, planning, designing and conducting experiments, analyzing data and documenting results towards continuous process improvement, including reducing recurring deviations, and increasing level of safety and/or compliance.
• 15 % of Time - Provide high quality of written study proposals, research and development reports, and investigation reports.
• 10 % of Time - 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 1 year work experience in the biotechnology industry.
Ability to work in a fast-paced environment with demonstrated capacity to juggle multiple tasks and demands.

**Preferred**
Hands-on experience in cell culture and/or depth filtration, ultra-filtration in lab or manufacturing scale.
Hands-on experience with bioreactor ATF perfusion operation
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.
Demonstrate teamwork/collaboration and the ability to communicate appropriately and effectively.
Be customer focused, results oriented, science driven and embrace Client values.
Have the attitude to proactively learn new technologies and manage changes in cell culture process development and improvement.

Complexity and Problem Solving
The individual will be expected to:
Execute cell culture or clarification process improvement, troubleshooting and manufacturing technical support.
Assist in analyzing complex technical problems, then finding and implementing solutions.
Apply fundamental scientific and biological principles to practical technical challenges.
Under supervision, plan and execute experimental studies.
Work closely with his/her supervisor and coworkers in managing multiple work streams and projects.
Provide input to departmental management towards making functional decisions.

Internal and External Contacts
Internally, this individual will represent the group to support manufacturing, as a customer with close interactions with the internal business partners including PD, QA, RA and ENG within client.
Externally, this individual will interact with vendors and suppliers who may supply raw materials or equipment both used in small-scale development lab and in large- scale manufacturing.