Scientist

Description

Duration: 6 months, extension and/or conversion to FTE possible based on performance and business needs.

Schedule: Core hours 9 to 4, 5 days a week, 8 hrs a day.

Onsite/Remote: 60% in the office after training

Job Overview:

• We are seeking an experienced external contractor to perform data review of laboratory experiments conducted at the Client Durham facility.
• This role requires scientific peer review of laboratory notebooks and regulatory documents.

Key Responsibilities:

Laboratory Data Review:

• Scientific data review of laboratory documentation and data to appropriate standards (GMPs, SOPs, protocols, methods).
• Good understanding of data integrity and ALCOA+ (Attributable, Legible, Contemporaneous, Original, and Accurate) principles.
• Peer review of results and documentation of product development studies including statistical data reports (JMP).
• Peer review of method validations and analytical technical transfers.
• Transcription checking of regulatory submissions, reports, and / or JMP tables / plots.

Required Skills:

• BS or MS in Chemistry, Pharmaceutical Sciences, or a similar applicable discipline.
• Experience with HPLC in a GMP / QC setting, Empower software preferred.
• Experience with Inhalation testing products, large and small molecule preferred.
• Strong understanding of GMP and FDA guidelines for pharmaceutical manufacturing and validation.
• Strong organizational skills for managing multiple priorities.
• Effective communication and interpersonal skills for coordination with lab personnel, and management.