Job Description:

Our client is seeking a Senior QC Analyst to join their expanding team in the RTP area. The Analytical Method Lifecycle Senior Associate will support the overall management and delivery of phase appropriate analytical method verification/qualification/validation and method transfer between clients and Resilience stakeholders. The Method Lifecycle Senior Analyst will ensure that all aspects of method lifecycle are conducted at the site in compliance with cGMP regulations, relevant compendial requirements, company policies, standards and procedures and safety standards. The Analytical Method Lifecycle Senior Analyst will support all site activities to ensure timely and successful execution of method lifecycle activities at the site. Specific activities include authoring/executing/review of study design, protocols and reports associated with analytical method qualification/validation/transfer. 70% of time will be executing studies outline in protocols.

Must Haves:

• Bachelor's Degree in STEM or related
• 5 years of experience in cGMP manufacturing
• Direct experience and understanding of ELISA, cell-based bioassays, molecular based assays such as PCR and ddPCR, kinetic binding assays, and particle sizing by DLS.
• Experience with real-time PRC and digital droplet PCR

Pluses:

• Experience with CE-SDS and AUC
• Previous experience in analytical technology transfer for biopharmaceuticals

Responsibilities:

• Support the site’s Analytical Method Lifecycle program encompassing all Quality activities to support method transfers and validation.
• Interface directly with client stakeholders for quality or compliance issues associated with analytical methods.
• Contribute to product specification development and ensure alignment with method capabilities.
• Support QC method/analytical investigations (OOS/OOT) at the site.
• Review and approve SOPs as required.
• Performs all other related duties as assigned.