MSAT Scientist I

NCBioImpact; Greenville (NC); On-site; USD 70,000 - 100,000; Full time

Job summary

NCBioImpact in North Carolina seeks a Scientist to support technology transfer by developing manufacturing processes for injectable products. You will design experiments, set formulation pathways, and prepare technical documentation for scale-up and transfer to client lines.

You will collaborate with cross-functional teams to create processes, equipment concepts, and protocols for clinical, scale-up, and registration batches, with strong GMP knowledge and 1+ year of related experience preferred.

Qualifications

• Bachelor's degree in a related physical science required.
• 1+ year of related experience preferred.
• Equivalents of education and meaningful work experience may be considered.

Responsibilities

• Support technology transfer by performing manufacturing process development for injectables.
• Use experimental design to establish formulation processes and scale-up pathways.
• Prepare work orders, protocols, summaries, and technical documentation for client projects.
• Participate in problem solving and project results for formulations, equipment, and processes.

Skills

Scientific method

GMP knowledge

Problem solving

Communication skills

Data analysis

Project coordination

Education

BS in Chemistry / Biochemistry / Biology / Pharmaceutical / Engineering or related physical science

Tools

Microsoft Office

Job description

Work Schedule

Standard Office Hours (40/wk)

Environmental Conditions

Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Support 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), 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.
• Works on technical/scientific process/product/project activities to implement strategies and technical solutions.
• Assists in the creation of processes, single use systems, and equipment designs for clinical, scale up, and/or registration batches, including technology transfer of projects from clients.
• Makes decisions that involve direct application of technical knowledge.

A Day in the Life.

• Support completion of studies, tech transfer, commercial scale-up and support process validation.
• Actively participate in problem solving and project results for formulations, equipment and processes.
• Write/revise work orders for existing processes, FORMs, reports, memos, and protocols.
• Support projects, implement change control actions.
• 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, Engineering or related physical science.

Experience:

• Bachelors and 1+ year of related experience PREFFERED.
• Experience in a CMO or Pharmaceutical product development field PREFERRED.

Equivalency:

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

Knowledge, Skills, Abilities:

• Excellent knowledge of scientific methodology and development as related to the pharmaceutical industry.
• 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.