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Job Details:

Duration: 09 months contract

Note: Remote- up to travel 25% to holly springs, NC

Job Summary:

+ Highly versatile and experience subject matter expert able to contribute as an individual or to lead teams across a wide range of drug substance technical areas. Responsible for aspects of the successful preparation, strategy, and execution of Technology Transfer, Process Scale-up, Clinical & Commercial Manufacturing Support, Process Performance Qualification (PPQ) during the start-up a of new Drug Substance production facility. Responsible for also being able to enable CMC Regulatory file drafting and support, commissioning and qualification of equipment, utilization of process models, process characterization, and process optimizations and troubleshooting. The qualified candidate will lead technical teams across various disciplines and objectives.

+ Some examples of Additional Responsibilities: Work cross-functionally with individuals and project teams in Process Development, Manufacturing, Quality, and Facilities and Engineering; Create and assess process technical assessments to support deviations and validations; create and execute to project plans and schedules; develop, execute, and review technical documents, validation documents, specifications, development plans, characterization plans, and verification and validation plans; provide deep technical assistance for junior engineers.

Must Required Skills:

+ Broad set of expertise across Drug Substance DS with extensive experience, including: Technology Transfer, Process Scale-up, Clinical & Commercial Manufacturing Support, Process Performance Qualification (PPQ), CMC Regulatory file drafting and support, commissioning and qualification of equipment, utilization of process models, process characterization, and process optimizations and troubleshooting.

+ Essentially someone at Principal Engineer or Director level in their current role

+ Strong technical and management skills, will need to deliver as an individual and team lead

+ Strong collaborations skills, track record of team environment success

About US Tech Solutions:

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.