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Planet Pharma · 23 hours ago

Engineer

Planet Pharma is a company focused on drug product technologies and manufacturing capabilities. They are seeking an Engineer to support senior staff in developing and characterizing these technologies, executing characterization studies, and assisting in technology transfer projects.
BiotechnologyHealthcarePharmaceuticalHealth Care
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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 Minitab, JMP etc
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

Process validationTechnology transferProject managementSAPData analysisMeticulous documentationGroup managementCritical thinkingProblem solvingCommunication skills

Required

Solid experience with software tools beyond Microsoft Office, like SAP or Smartsheet's
Excel in group management, deadline adherence, and meticulous documentation skills
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 Minitab, JMP etc
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

Preferred

B.S. in scientific or engineering discipline with 1-3 years experience or M.S. in scientific or engineering discipline with 0-2 years experience
Familiarity with cGMP and experience in drug product / drug substance manufacturing or process development
Knowledge of and hands-on experience with various drug product technologies
Displayed 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
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

Company

Planet Pharma

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Planet Pharma is a pharmaceuticals company.

H1B Sponsorship

Planet Pharma 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
2022 (3)
2021 (5)
2020 (5)

Funding

Current Stage
Late Stage

Leadership Team

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Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
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Emma Morris
President, PPG Advisory Partners
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Company data provided by crunchbase