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Manufacturing Scientist II (Technology Transfer)

Location Greenville, ノースカロライナ州, アメリカ合衆国 Job Id R-01305126 Job Type フルタイム Category 研究開発 Remote すべてオンサイト
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JOB DESCRIPTION

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards、 Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Complete Technology Transfer activities by performing manufacturing process development for Injectables products to commercial lines. Using experimental design, establish formulation processes, product pathway and select components for successful scaleup. Support client calls, prepare documentation (including but not limited to work orders, protocols, summaries, with minimum supervision), and provides scientific justification and update status of project work as needed.

Discover Impactful Work!

  • Technically supports day-to-day operations in the Formulation, Filling, and/or Freeze Drying areas of the Steriles plant.
  • May be involved in clinical stage of drug development.
  • Works on technical/scientific process/product/project activities to implement strategies and technical solutions that meet client and expectations.
  • Assists in the creation of processes and equipment design for clinical, scale up, and/or registration batches, including technology transfer of projects to and from clients.
  • Evaluates and designs manufacturing processes and supports problem solving as needed within defined procedures and practices.
  • Makes decisions that involve direct application of technical knowledge.

A Day in the Life.

  • Complete studies, tech transfer, commercial scale-up and support process validation.
  • Represent the organization on internal technical discussions.
  • Actively participate in problem solving and project results for formulations, equipment and processes.
  • Write/revise manufacturing and filling work orders for existing and new processes.
  • Write reports, protocols, and summaries.
  • Lead projects with a moderate level of supervision, complete change control actions in a timely manner.
  • Review and plan technical aspects of the project to meet timeline and project goals.
  • Support manufacturing operations, change controls, investigations as SME,
  • Collects data for statistical analysis. Can support interpretation and summary of data.

Keys to Success

Education:

  • Bachelor’s of Science in Chemistry, Biochemistry, Biology, Pharmaceutical or related physical science.

Experience:

  • Bachelors and 2+ years of related experience, or, related Master’s degree.
  • Experience in a CMO, Technology Transfer, or Pharmaceutical product development PREFERRED

Equivalency:

  • Equivalent combinations of education, training, and meaningful work experience may be considered.

Knowledge, Skills, Abilities:

  • Detailed knowledge of pharmaceutical processes technology transfer and process development.
  • Detailed knowledge of Good Manufacturing Practices.
  • Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint). Excellent critical and logical thinking skills.
  • Effective written, interpersonal, and presentation skills, including running technical discussions with internal and external clients.
  • Ability to work on multiple projects simultaneously.
  • Ability to acquire knowledge and skills in pharmaceutical processes, equipment, instrumentation, and procedures.
  • Ability to keep current with scientific literature and industry trends relating to process technologies.
  • Ability to run technical solutions.
  • Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand and walk; ability to lift and/or carry light objects of up to 25 lbs. for brief periods.
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