Scientist#25-65626
Durham, NC
All On-site
Job Description
Location: Durham, NC
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
Max bill rate: ***
Interview Process: Onsite interview, 1 panel interview, 1 hr
Job Overview:
We are seeking an experienced external contractor to perform data review of laboratory experiments conducted at the *** Durham facility. This role requires scientific peer review of laboratory notebooks and regulatory documents.
Key Responsibilities:
1. Laboratory Data Review:
o Scientific data review of laboratory documentation and data to appropriate standards (GMPs, SOPs, protocols, methods).
o Good understanding of data integrity and ALCOA+ (Attributable, Legible, Contemporaneous, Original, and Accurate) principles.
o Peer review of results and documentation of product development studies including statistical data reports (JMP).
o Peer review of method validations and analytical technical transfers.
o 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.
EEO:
Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of - Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.
Durham, NC
All On-site
Job Description
Location: Durham, NC
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
Max bill rate: ***
Interview Process: Onsite interview, 1 panel interview, 1 hr
Job Overview:
We are seeking an experienced external contractor to perform data review of laboratory experiments conducted at the *** Durham facility. This role requires scientific peer review of laboratory notebooks and regulatory documents.
Key Responsibilities:
1. Laboratory Data Review:
o Scientific data review of laboratory documentation and data to appropriate standards (GMPs, SOPs, protocols, methods).
o Good understanding of data integrity and ALCOA+ (Attributable, Legible, Contemporaneous, Original, and Accurate) principles.
o Peer review of results and documentation of product development studies including statistical data reports (JMP).
o Peer review of method validations and analytical technical transfers.
o 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.
EEO:
Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of - Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.
Job ID: 486849892
Originally Posted on: 7/25/2025
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