Would you like to apply your experience in managing a GMP testing laboratory and knowledge of cGMP and regulatory requirements for cell-based products, particularly CAR T-cells? If so, join our Cell Therapy as an Associate Director, MS&T Analytical Team. The selected candidate will lead the cell therapy analytical method transfer from internal and external development organizations to support clinical-stage cell therapy product production and release by GMP regulations. This includes lot release... more details
Would you like to apply your experience in managing a GMP testing laboratory and knowledge of cGMP and regulatory requirements for cell-based products, particularly CAR T-cells? If so, join our Cell Therapy as an Associate Director, MS&T Analytical Team. The selected candidate will lead the cell therapy analytical method transfer from internal and external development organizations to support clinical-stage cell therapy product production and release by GMP regulations. This includes lot release and stability tests, critical reagents qualification, and analytical method validations. The team engages with analytical development and several cross-functional teams including clinical, regulatory, QA, and manufacturing.
You will be accountable for developing, managing, and retaining bench strength and leadership across the analytical functions within MS&T through coaching, mentoring, and providing development opportunities to the team members. Success in these areas will require strong technical/scientific and management leadership skills, experience with the commercialization of biologics, analytical technologies, project management, and the ability to project cross-functional influence.
What you will do:
Work collaboratively within the cell therapy technical operations (CTTO) group, analytical development, and RMC QC to manage the analytical transfer to QC operation.
Ensure that the analytical GMP laboratory is efficient and compliant with regulatory, industry, and AstraZeneca standards.
As a key member of the MS&T analytical sciences team, you will provide strategic direction to ensure GMP compliance is met in all analytical activities.
Lead and develop a team of scientists responsible for GMP lot release and stability testing, management of critical reagent and stability-related activities, sample chain of custody, and analytical tech transfer.
Drive lot release activities to maintain short vein-to-vein times.
Represent the analytical GMP function in cross-functional leadership team meetings related to manufacturing, analytical development, compliance, and lot release.
Author, review, and approve SOPs, protocols, reports, and other relevant documentation.
Represent RMC MS&T Analytical Sciences during regulatory and internal inspections.
Work collaboratively with the Analytical Development team to ensure that analytical methods are appropriate and meet current regulatory requirements.
Minimum Qualifications:
BS/MS/PhD in Cell or Molecular Biology, Immunology, Biological Sciences, Biotechnology, Biochemistry, or related field.
B.S. with a minimum of 8 years of experience, M.S. with a minimum of 5 years of experience, or Ph.D. with a minimum of 3 years of experience.
Prior experience managing a GMP testing laboratory and knowledge of cGMP and regulatory requirements for cell-based products, particularly CAR T-cells.
Demonstrated ability to lead a team responsible for multiple project activities and ability to set the proper priorities to implement them effectively.
Expertise with methods and techniques for analysis of cell therapy products, such as Flow Cytometry, ELISA, qPCR, dPCR, cell culture, cell count and viability measurement, and cytotoxicity assays.
Ability to author, review, and approve CMC documentation for health authority responses and for regulatory filings.
Excellent written and verbal communication skills in a cross-functional environment.
Demonstrated ability to make decisions under pressure that balance patient safety, compliance, and supply.
Strong critical thinking skills.
Strong interpersonal skills and demonstrated ability to effectively work across a large organization.
Preferred Qualifications:
Prior experience performing/leading analytical testing of multiple products with short turn-around times.
Experience with cell therapy regulatory inspections.
Experience with Labware Laboratory Information System (LIMS).
Why AstraZeneca
At AstraZeneca, we are leading our Operations function at an exciting time of growth and evolution. We pioneer new approaches and processes across our sites, empowering our teams to foster a Lean mindset and sustainable practices. Every change we make is to deliver better outcomes for our patients. We are the champions of Lean, ensuring our teams understand and embody the benefits it can bring. Our manufacturing sites are environments of constant and rapid change. It's a place to expect the unexpected. There's rarely an obvious answer to the varied challenges we face, so it takes adaptability, flexibility, and patience to thrive here.
Ready to make your mark? Apply today and be part of a team that’s redefining the science of medicine!
Date Posted
03-Jul-2024
Closing Date
17-Jul-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.