Associate Director QC, Bioanalytics

Are you passionate about significantly improving the future of medicine? Do you believe that people are the most important asset of any company? If so, join AmplifyBio! 

AmplifyBio is a leading contract research organization with a comprehensive range of services that span from being an outsourcing partner for discovery stage R&D work, a preclinical CRO performing safety efficacy and toxicology studies for small molecules and advanced therapies alike, and, most recently, an expansion into manufacturing services for cell, gene, and mRNA-based therapeutics. 

The AmplifyBio ecosystem is comprised of three distinct business units: ADOC (South San Francisco, CA)– Amplify's Discovery, Optimization, and Characterization laboratories: ASET (West Jefferson, OH) – Amplify's Safety, Efficacy, and Toxicology Site; and the most recently opened AMEC (New Albany, OH) – Amplify's Manufacturing Enablement Center.  

About ADOC South San Francisco, CA.  AmplifyBio’s discovery optimization and characterization unit (ADOC) establishes critical product characterization benchmarks, optimizes efficacy, and identifies new targets and strategies for clients preparing to scale up the production of therapeutic candidates. The site also houses GMP manufacturing suites, and quality labs available to clients. Based on broad experience in cell and gene therapy manufacturing, this group seeks to address the widening gap between R&D and manufacturing CMC. 

AmplifyBio is seeking to hire an Associate Director Quality Control, Bioanalytics to join our growing team!!!

What You’ll Do Here: 

• Manage bioanalytical testing services provided to AmplifyBio clients, in support of process development, product manufacturing, product release, and stability evaluation. 
• Oversee the day-to-day operations of QC Bioanalytics group, including personnel and equipment supporting the client’s manufacturing in the GMP manufacturing facilities.
• Review records of testing and studies performed by the QC Bioanalytics group to assure accuracy, completeness, and in conformance with the applicable procedures and regulatory compliance.
• Ensure adherence to cGMP practices applicable to QC laboratory operations and testing performed by QC Bioanalytic group.
• Manage the technical transfer, qualification, and validation of analytical procedures for AmplifyBio clients including commissioning and qualification of laboratory equipment used in the QC Bioanalytics laboratory.
• Implement and maintain quality systems and assures their area of responsibilities comply to those system. 
• Supervise personnel to achieve optimal productivity and proficiency, including setting personnel goals in alignment with department and company objectives.
• Foster an empowering environment where team members develop innovative solutions that improve performance, gains team support for change.
• Establish expectations for collaboration within the team and model effective collaboration with other teams and departments and build strong partnerships that lead to improved results.
• Assure staff are appropriately trained to perform their work assignments and responsibilities.
• Assure the safety of all staff working within designated spaces, including providing training and oversight of related activities and responding to safety inspections and audits.

We Would Love to Hear from You If: 

• Minimum of a Bachelor of Science degree in at least one of the biological sciences (e.g. Molecular Biology, Cell Biology, Biochemistry) or related field of study, with at least 10 years of relevant experience or 6 years with graduate degree.
• Minimum of 5 years of experience supervising, mentoring, and training personnel in a laboratory setting.
• Have had hands-on experience  sufficient to serve as a Subject Matter Expert in bioanalytical assays, including but not limited to flow cytometry/FACS, PCR (qPCR/ddPCR), immunoassays, or bioassays, or other bioanalytical methods.
• Experience managing a GMP laboratory operation and personnel performing drug product and drug substance release testing, including investigation and resolution of non-conformance and out of specification.
• Experience with conducting drug product and drug substance stability studies in accordance with ICH Q1A.
• Experience performing or managing analytical procedure qualification/validation and technology transfer from R&D environments and external laboratories to QC.
• Experience supporting regulatory and/or client audit programs.
• Exp