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 ADOCSouth 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 anAssociate DirectorQuality 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.
• Experience with a Lab Information Management Systems and Quality Management Systems are preferred.
• Experience managing GMP analytical laboratory equipment throughout equipment lifecycle, including commissioning, IQOQ, PQ, and decommissioning.
• Ability to be organized, multitask, communicate effectively with a team of diverse individuals, and a desire to learn new skills.
• Highly self-motivated with strong work ethic and drive to lead process improvements and capability expansion within designated lab areas.
• Excel in a fast-paced team environment, handles multiple tasks concurrently, and delivers in a timely fashion.
• Strong interpersonal skills, highly collaborative within a multi-discipline team and contributes to a supportive and positive work environment.

At AmplifyBio we're committed to growing and empowering an inclusive community within our company and industry. This is why we hire and cultivate diverse teams of the best and brightest from all backgrounds, experiences, and perspectives across our organization.

AmplifyBio is an equal opportunity employer, and we value diversity at our company. We don't discriminate on the basis of race, color, citizenship status, national origin, ancestry, gender (including gender expression and gender identity), sexual orientation, age, weight, religion, creed, physical or mental disability, marital status, veteran status, political affiliation, or any other factor protected by federal, state, or local law.

Why You Will Love Working Here:
We take the health and happiness of our employees seriously and consistently evaluate new ways to Amp up our benefits to provide an amazing place to work. From a wellness program to financial planning and legal assistance, we make sure to take care of our own.

• Health, Dental, and Vision insurance that starts on your first day at AmplifyBio!
• Competitive Compensation Package
• We take work-life balance seriously and we back it up with a FLEIXIBLE PTO program!
• Generous paid parental leave
• Wellness and Self-Care Programs
• 401(k) match
• Tuition Reimbursement
• EAP/work-life support system
• A fun work environment where everyone’s voice matters
• We are just getting started! More benefits on the way!
• An Opportunity to Change the World!!!

When you join our team, you will be a part of groundbreaking work while collaborating with our clients, research scientists, study directors, lab technicians, and specialists across a variety of disciplines. The future for AmplifyBio is as great as the combination of our imaginations and actions, and we hold ourselves accountable for our choices and results. We have a bias for action, excellence, and, especially, the health and safety of our employees.