drjobs Scientist III, Manufacturing Sciences

Scientist III, Manufacturing Sciences

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1 Vacancy
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Job Location drjobs

Greenville - USA

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Able to lift 40 lbs. without assistance Adherence to all Good Manufacturing Practices (GMP) Safety Standards Cold Room/Freezers -22degreesF/-6degrees C Laboratory Setting Loud Noises (Equipment/Machinery) Office Rapid flashing lights Some degree of PPE (Personal Protective Equipment) required (safety glasses gowning gloves lab coat ear plugs etc.) Standing for full shift Strong Odors (chemical lubricants biological products etc.) Will work with hazardous/toxic materials

Job Description

Location/Division Specific Information:
Greenville NC/Drug Product Division.
Shift: 8:00am4:30pm Monday through Friday with overtime as needed.
NOTE: Some off-hours may be required.
Discover Impactful Work:
As a Scientist III you will support sterile manufacturing processes for both traditional aseptic and isolator manufacturing environments. Responsibilities include scaling new processes supporting product validation and post-approval qualifications and supporting routine operations to ensure timely product release. You will serve as the technical representative on client projects and collaborate with analytical quality and project management teams to drive successful process development commercialization and day-to-day operations.
Key Responsibilities:
  • Collaborate with cross-functional teams to support product and process development in commercial manufacturing.
  • Lead technical planning and client interactions ensuring alignment across multiple projects.
  • Apply risk-based approaches to process scale-up and commercialization developing mitigation strategies.
  • Prepare batch records protocols and reports for development validation and routine production.
  • Act as technical steward for assigned products supporting routine manufacturing.
  • Investigate new scientific methodologies for controlling raw materials intermediates and final products.
  • Implement strategies and technical solutions to meet client needs.
  • Identify and document deviations from standard operating procedures (SOPs) quality standards or regulatory guidelines.
  • Conduct product investigations and develop CAPAs.
  • Analyze deviation trends and provide insights for continuous improvement.
Preferred Knowledge/Skills:
  • Knowledge of scientific methodology and development in the pharmaceutical industry.
  • Understanding of Good Manufacturing Practices.
  • Proficiency in Microsoft Office Suite.
  • Excellent critical thinking problem-solving and technical writing skills.
  • Effective communication and presentation skills with the ability to lead technical discussions.
  • Ability to evaluate data develop technical solutions and make recommendations.
  • Knowledge of regulatory requirements (e.g. FDA EMA ISO) and industry standards.
  • Proficiency in quality management systems (QMS) and relevant software tools.

Qualifications:
Bachelors Degree required ideally in Chemistry Biology or a related physical science with a minimum of 5 years of relevant experience. An equivalent combination of education and relevant experience may be considered.
Physical Requirements:
  • Stand for extended periods.
  • Handle chemicals and operate various laboratory equipment.
  • Lift up to 40 pounds without assistance.
  • Adhere to all Good Manufacturing Practices (GMP) Safety Standards.
  • Work in cold room/freezer environments (-22F/-6C).
  • Work in laboratory and office settings.
  • Use personal protective equipment (PPE) such as safety glasses gowning gloves lab coat and ear plugs.
Benefits:
We offer competitive remuneration annual incentive plan bonus healthcare and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative forward-thinking organization and outstanding career and development prospects. We offer an exciting company culture that stands for integrity intensity involvement and innovation!

Employment Type

Full-Time

Company Industry

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