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Manufacturing Scientist III

Location Greenville, ノースカロライナ州, アメリカ合衆国 Job Id R-01305172 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、 Office、 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. Lead client calls, prepare necessary documentation (including but not limited to work orders, protocols, summaries, with minimum supervision), and provides scientific justification as needed and update status of project work.
 

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.

  • Crafts technical/scientific process/product/project activities to implement strategies and technical solutions that meet client expectations.

  • Drives the creation of processes and equipment design for clinical, scale up, and/or registration batches, including technology transfer of projects 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.

Support manufacturing operations, change controls, investigations as (SME), resolve accurate CAPAs.

  • Design and complete studies, lead tech transfer, commercial scale-up and support process validation.

  • Represent the organization on formal technical and scientific forums.

  • Lead and/or participate in problem solving and project work for formulations, equipment and processes.

  • Write/revise manufacturing and filling work orders for existing and new processes with no supervision.

  • Write reports, protocols, and summaries.

  • Lead projects with minimal to no supervision, can review and plan all technical aspects of the project to meet appropriate timeline and project goals.

  • Assess material changes and change impact.

  • Support creation of proposals and timelines for projects, leading relevant client meetings.

  • Review new bid quotes, protocols, technical documents, results, and reports.

Keys to Success
Education:

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

Experience:

  • Bachelors and 4+ 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:

  • Excellent knowledge of pharmaceutical processes, technology transfer, process development, and scientific methodology as related to the pharmaceutical industry.

  • Detailed knowledge of Good Manufacturing Practices.

  • Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint).

  • Effective written, interpersonal, and presentation skills, including leading technical discussions with internal and external clients.

  • Ability to work on multiple projects simultaneously.

  • Ability to keep current with scientific literature and industry trends.

  • Ability to develop 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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