Job Description

Job Responsibilities:

• Author technical reports, policies, and Standard Operating Procedures.
• Author/review, format, and revise reports, protocols, analytical method validations, and CMC sections for regulatory submissions.
• Author investigations, deviations, change controls, and other non-conformance records.
• Work with vendors to coordinate testing and arrange shipments as needed.
• Compile and review scientific data for completeness as needed.
• Perform trending and evaluation for continuous monitoring of stability data and shelf-life extension.
• Use of LIMS database including protocol setup, data entry/approval, and data trending.
• Process invoices, purchase orders, and other agreements. Interact with finance and vendors to confirm work and adjust budget forecasts.
• Coordinate document review, approval, and archiving.
• Participate in analytical lab activities, on an as needed basis.

Skills:

• Proficiency in Scientific Writing/Technical Writing,
• Experience in Empower chromatographic data system,
• Experience with LIMS, SAP/SRM, Track Wise, and Veeva,
• Experience in GMP/GLP and/or a regulated industry.

Education/Experience:

• At least 2-3 years scientific/analytical lab experience, preferably in the field of protein therapeutics or monoclonal antibody therapies.
• Proficient in scientific/technical writing.
• Experience in Empower chromatographic data system
• Experience with LIMS, SAP/SRM, Track Wise, and Veeva.
• Excellent oral communication, interpersonal and technical writing skills.
• Excellent organizational skills, demonstrate attention to detail.
• Experience in GMP/GLP and/or a regulated industry.
• Strong background in Microsoft applications such as Word, Excel, SharePoint a must.
• Advanced Excel knowledge is a plus.
• BS in Chemistry, Biology or a related scientific discipline.

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