Technology Transfer Engineer/ Scientist

NewAgeSys, Inc.

Rochester, NY, USA Remote / WFH

Nov 15

* Req Number: 4479
* Req Title: Technology Transfer Scientist II
* Client: A major pharma company
* Work Address: 100 Indigo Creek Drive USRO1, 14626 United States, Rochester, NY Duration: 13 Months
* Hours per Week: 40.0

*Position Summary: *

* The individual is responsible for the execution of the process transfer and launch implementation activities associated with the introduction of new products using the Product Delivery Process (PDP.)
* The individual must balance the needs of the key customer base within Operations and Research & Development and ensure the timely introduction of the new product against the key milestones to meet product launch dates.

*Responsibilities: *

* Translation of development formulations into manufacturing documentation to support process transfer activities with a thorough understanding of operational needs and ability to translate these needs and influence process design.
* Responsible for representing operations within cross functional new product development project teams during all phases of the PDS (for equipment or assays) system.
* Interface between the product development team and operational value centers and soliciting operational feedback on proposals generated within the project team. Demonstrated ability to independently generate and executes plans to meet overall project schedule.
* Ability to update plans and identify corrective actions to resolve schedule conflicts to meet project agreed deliverables.
* Responsible for leading the cross functional NPI Plant team meetings. Responsible for the physical handover of production process to operations ensuring all current factory processes are utilized where possible.
* Support the product support representative to conduct front line trouble shooting of any in-process failures associated with new production processes utilizing the non-conformance procedures during all phases.
* Execution of operational launch implementation activities including co-ordination of the completion of the Device Master record (DMR) and generation of change control documentation.
* Identify and implement process improvements related to tech transfer work.
* Actively solicits opinions and ideas from others.
* Transfer methods according to the Operational Requirements Document (ORD) to ensure the verification of process CTQ’s and define the process latitudes for new processes.
* Perform other work-related duties as assigned.

Qualifications:

* Degree in Chemistry, Biochemistry, Biology or similar discipline preferred or minimum of 5 years experience in a Tech Transfer, Operations or Product Development/Support role within a GMP manufacutring facility.
* Minimum of 5 years of experience in an Operational or Technical environment. Demonstrated ability to successfully deliver against project timelines.
* Track record of contributing to cross-functional teams within a regulated environment. Position is primarily site-based, with less than 5% travel per year.

Job Types: Full-time, Contract

Schedule:
* 8 hour shift

Education:
* Bachelor's (Required)

Experience:
* Technical Transfer/Product Development/ Technical Operations: 3 years (Required)
* CGMP: 2 years (Required)
* Formulations: 1 year (Preferred)

Work Location: One location

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