4509 Associate Manufacturing Technical Specialist

Duties
The production facility makes pharmaceutical proteins from mammalian cells using large-scale production techniques.
The contractor’s group provides technical support and stewardship for cell culture operations of the process, which focuses on mammalian cell culture growth and production of drug substance.
We play a key role during all aspects of the product lifecycle, from transfer into the manufacturing facility through commercialization and ongoing monitoring of operations, to ensure consistent process performance.

Responsibilities/activities may include, but not limited to:
Working with engineers and specialists to learn the science behind the cell culture operations of the manufacturing process.
Responsible for writing protocols, executing studies (small scale and large scale), and writing reports to support process characterization and validation activities per Validation Project Plan and Tech Transfer Activities.
Assisting in laboratory operations, including media and bioreactor preparation, maintaining analytical equipment and monitoring of cell culture step performance.
Completing small scale experiments for scale down bioreactor operations.
Responsible for coordinating technical meetings (ie. setting up the meetings, communicating agenda, and drafting minutes).
Assist in review of User Requirement Specifications, Critically Assessments, System Impact Assessments, and Risk Assessments.
Project debug and implementation support.
The position may involve some work during non-business hours.

Skills
Contractor must possess good problem solving, interpersonal, communication, and team skills. Contractor must be a self starter with a strong focus on quality, details, and results.
We care more that this person possesses these soft skills than their technical skills.
We will teach them what they need to know.
Previous experience with small scale cell culturing and/or working in a laboratory setting is a bonus.

Education
To be eligible for this position, contractor must have completed BS or higher degree at an accredited college or university and 0-3 years of experience in process validation and/or cell culture operations.

PLEASE NOTE: Our client has mandated COVID-19 vaccination for their workforce, all external personnel providing services to our client are required to comply with this requirement.