Engineer, GMP Biotech Process Tech transfer (JP14599) jobs in United States
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3 Key Consulting, Inc. · 3 months ago

Engineer, GMP Biotech Process Tech transfer (JP14599)

3 Key Consulting is hiring an Engineer for a consulting engagement with a leading global biopharmaceutical company. The role focuses on supporting senior staff in developing and characterizing drug product technologies, as well as assisting in process validation and technology transfer to manufacturing plants.

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H1B Sponsor Likelynote

Responsibilities

Apply fundamental engineering and scientific principles to resolve issues and evaluate effects of process improvements, equipment, scale, and raw materials
Assist in the design and execution of experiments in order to characterize and enable implementation of new capabilities and process changes such as filling, lyophilization and analytical technologies
Support technology transfer leads during the transfer of drug products into manufacturing sites (clinical and commercial), including make-a-batch exercises, process parameter risk assessments, process transfer documents, and change control assessments
Support development and maintenance of technology transfer tools (clinical and commercial)
Effectively communicate results of characterization studies, experimental execution and technology transfer initiatives
Author/review/data verify technical documents, such as technical protocols, technical assessments, technical reports and draft standard operating procedures or guideline documents
Conduct analysis of data generated, including statistical analysis using applicable software
Development of digital tools and models by leveraging data analytics and programming skills
Support at scale characterization and/or process validation runs as person in plant

Qualification

Tech transfer experienceGMP environment experienceBiologic drug product knowledgeCGxP familiarityChemical EngineeringBiotechnologyPharmaceutical ScienceProject management skillsCommunication skillsCritical thinkingProblem solvingAttention to detailSelf-motivated

Required

Master's Degree - 0 -2 years industry experience
Bachelor's Degree - minimum of 2 years industry experience
Bachelor's degree in any scientific or engineering discipline with 1 – 3 years professional working experience
Solid working experience with standard software tools such as Microsoft Office
Excellent project management skills and ability to escalate relevant issues to project lead and line-management
Strong cross functional team player with good communication skills (oral and written)
Ability to work independently and as part of a team with internal and external partners
Good computer and organizational skills with strong attention to detail
Self-motivated with a positive attitude

Preferred

Tech transfer experience
Preferably from BioPharma Industry
Familiarity with cGxP and experience in drug product / drug substance manufacturing or process development
Knowledge of and hands-on experience with various drug product technologies
Displays critical thinking, problem solving and independent research skills
Ability to learn new techniques, perform multiple tasks, keep accurate records, follow instructions, and comply with company policies

Benefits

With benefits

Company

3 Key Consulting, Inc.

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3Key Consulting specializes in the rapid recruitment and placement of business and IT professional within the life sciences and healthcare industries.

H1B Sponsorship

3 Key Consulting, Inc. has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2020 (6)

Funding

Current Stage
Growth Stage

Leadership Team

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Ahmad Hussein
CEO, Executive Talent Acquisition, Business Development Leader
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Company data provided by crunchbase