Bioassay Lead

Bioassay Lead
Location: North Carolina
Salary Range: $120-135k

HireMinds is helping our client build a new manufacturing site in North Carolina and seeking your expertise in leading a team and focused in Bioassay Analytical services role.  As the Lead on the bioassay team, you’ll help recruit and lead a team of skilled bioanalytical scientists in managing laboratory functions and conducting bioassay and cell-based assay testing. Your role involves ensuring regulatory compliance, providing scientific insight, and maintaining a reputation for excellence in support of client priority projects. We’re looking for a leader with demonstrated management experience, a strong understanding of bioassays, cell-base assays, and excellent communication skill to help build this team. 

You’ll Be Responsible For:
•    Development and Management of a team of technicians. 
•    Assist in buildout of new lab and planning and coordination of laboratory tasks with the Site Head and Quality team. 
•    Ability to implement lean process management principals and protocols. 
•    Guide the team on troubleshooting technical issues. 
•    Plan lab timelines to ensure on-time delivery of analytical results. 
•    Experience as Subject matter expert in Bioassay critical GMP cases. 
•    Ability to implement SOPS and team compliance with GMP, cGMP, and other Quality requirements. 
•    Help steer relationships as main point of contact for customer audits and inspections by authorities. 
•    Assist in the process of creating realistic quotes for analysis services within scope and budget balancing customer and company demands. 

You’ll Bring With You:
MS or Ph.D. in Cellular Biology, Biochemistry, or Related disciplines with industry experience in CRO/CDMO environments.
•    A track record of Assay development and delivery in GMP, cell biology/biochemistry, analytical sciences. 
•    Experience in mentoring and leading teams. 
•    Expertise with in vitro GMP potency testing from early development to routine batch releases, functional bioassays, ligand binding assays and best instruments, technologies, and practices. 
•    Experience with implementation and use of Software such as SoftMaxPro, Gen5, PLA 3.0, and LIMS tracking systems. 
•    Deep knowledge of relevant ICH and USP chapters and industry best practice. 
•    Strong communication and coaching skills as a mentor exhibited in past experience.